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February 2015 Vol.13 Issue 7 Mumbai Price ` 150

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Vaccines

South 2015 10-12, December 2015

Chennai, India

Gujarat 201621-23, January 2016Ahmedabad, India

Pharma Bio World4 February 2015

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INTERVIEW

“Global collaborative approach is required to develop new biologics”– Dr Harish Iyer, CEO, Shantha Biotechnics

FEATURESVaccines – Enhancing Global Value and Prioritizing Safety, Efficacy and Delivery – Dr Madhusudan P Dabhole

Molecular Pharming in Plants for Vaccines– Kathleen Hefferon

Considerations while Selecting Peptones for Biotechnology Applications – Dr Chris Potter

The Future of Pharmaceutical Processing & Packaging– Dr Johannes Rauschnabel

Best Practices in Coding Innovative Pharmaceutical Packaging– Richard Nemesi

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Budget 2015: Wish List for the Pharma Sector– Sanjay Sanghvi, Suhas Sagar

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In consonance with ‘Make in India’ campaign, Shantha opened its new insulin manufacturing unit at Telangana. The press release talks about manufacturing of 60 million cartridges of Insuman in next 2-3 years. Which are the targeted international markets for Insuman and key challenges that need to be addressed?

The Insuman is a tech transfer project from Frankfurt; we need to ensure that the cartridges are made in an affordable way while maintaining global quality standards. We will need the support of the government for necessary permissions to have this manufacturing facility approved. Our production facility will manufacture Insuman for the Indian market initially, and later expand to other markets such as the EU.

Shantha biotech has re-launched its paediatric pentavalent vaccine Shan5 very recently. According to information available in the public domain, when WHO had cancelled Shantha’s blockbuster vaccine in 2011, it opened up opportunities for makers of the same vaccine like Panacea Biotech, Serum Institute, Novartis etc. Now, what are the strategies you planned to recapture pentavalent vaccine market for Shan5 in India and globally?

Shantha will continue its mission of increasing the availability of vaccines to the developing world. We

will achieve this through increasing our capacity of affordable and quality vaccines. At the same time, we will continue investing in technology, equipment and our employees to further strengthen our competitive edge to become an important, reliable supplier of Shan5 and other vaccines.

May we have your comments on the pros and cons on producing combination vaccines. How do you see the market shaping up for these in terms of demand and affordability in India and globally?

Combination vaccines reduce the number of injections required to protect infants from deadly preventable diseases. As a consequence, the pain caused to babies is reduced - reducing the emotional pain caused to their parents as well. Apart from this, combination vaccines also reduce the cold storage required in the supply chain as multiple vaccines are stored in one bottle.

G loba l l y, the t rend has been to move towards combination vaccines; the introduction of pentavalent vaccine in the Universal Immunization Program (UIP) in India is an example of this. With a birth cohort of 27 million babies, there is a significant demand for vaccines in India and it will expected to grow up to 100 million doses as more states take up this vaccine in their expansion program.

“Global collaborative approach is required to develop new biologics”

In an exclusive interview with Pharma Bio World, Dr Harish Iyer, CEO, Shantha Biotechnics discusses various factors, trends and strategies to be adopted to make a significant impact in the growth and progress of the ever changing Indian biologic industry.


interviewTo what extent , is an unvaccinated individual a potential health hazard for others?

Unvaccinated individuals pose a threat to themselves and others. You can take the examples of whooping cough outbreaks (caused by pertussis) in California in 2013 where unvaccinated children spread the disease. Incidentally, whooping cough is one of the diseases that are prevented by a pentavalent vaccine such as Shan5. Recent (2014) measles outbreaks in the US, almost 15 years after the disease was thought to be eliminated, highlight concerns connected with unvaccinated individuals.

May we have your comments on the whole anti vaccine movement that has spread out creating fear about the potential side effects of vaccines?

Va c c i n a t i o n i s t h e m o s t s u c c e s s f u l intervention in public health. We need to make people understand the benefits of vaccination and educate them about the importance of vaccination as well.

The most recent and best example that you have is of Polio. The Polio immunization program was taken up on a war footing in India, and the result is that we have had no polio cases reported in the last two years. On a global level, the number of cases reported was 350,000 in 1988 to just a few 100s now.

Albeit the fact that India is one of the biopharmaceutical hubs, why don’t we have not much indigenous vaccines to our credit? What are the challenges that we need to address to realize the vision 2025 to reach USD 100 billion industry?

As a country, India has developed a few indigenous vaccines and brought them to market: the first oral cholera vaccine for mass immunization (Shanchol), the first indigenously developed rotarvirus vaccine (Rotavac) and the meningococcal A vaccine (MenAfrivacA). These vaccines have been

developed using a broad internat ional network of col laborators from both the northern and southern geographies, global funding agencies, and with the ability to transfer technologies between regions. Such vaccines are expected to have a significant impact on public health in the poorer parts of the world: we must take credit for this. In a broader sense, this g loba l co l labora t ive approach wi l l be required to develop new products - No single geography or institution possesses all the requisite capacities and capabilities - whether they are vaccines or other biologics.

The overal l expenditure on healthcare is India is 4 per cent of GDP and public spending is just around 1 per cent: a fraction of the overall spending. In order to achieve the 2025 v is ion, we need to have the necessary climate to enable many aspects:

• Moveup thevaluechain fromgenericsto innovat ion , and f rom t rad i t iona l pharmaceuticals and vaccines to include biologics

• Increase heal thcare spending f romthe current low of 1 per cent to invest upwards of 5 per cent of GDP in the health of the population

• Policiesandregulationsshouldencourageentrepreneurship and formation of new firms that can create new products for the public

• Co l l a bo r a t i o n be tween a cadem i aand indus t r y and ac t i ve l y p rov ide opportunities for scientists to work in partnerships through various platforms

What is your observation on ethicality of vaccine clinical trials conducted in India? How do you compare these with the ones carried out in developed countries?

Clinical trials are often required by law to allow medicines to obtain regulatory authorization for commercial supply. Such trials in India allow the medical community to understand how these vaccines behave in the Indian population and ult imately allow our population to have access to the newest products which impact public health. These studies have to be carried

out as per our laws to get approval in India. All the clinical trials have to be done with the appropriate oversight (eg; Institutional Ethics Committees, etc.), under appropriate Good Clinical Practices (GCP) and no one should tolerate any deviation from the set standards. These rules and laws are in place to protect all the subjects that undergo these trials and also to ensure the reliability of the conclusions of the clinical study.

What are the emerging new t rends in vaccine development process and vaccine platforms?

Vaccines are undoubtedly one of the greatest achievements in the f ield of medicine. However, vaccine development tends to be conservative as it is an intervention in relatively healthy populations.

C o u n t r i e s a n d g l o b a l o r g a n i z a t i o n s (eg; GAVI, BMGF) have now identi f ied vaccination as a critical aspect of their public health and have understood its importance in combating endemic disease and potential outbreaks, reducing mortality in people of all ages, but particularly in infants. To start off, there has been a significant coverage globally in very basic vaccines such as DTP, polio. Newer vaccines are being introduced to reduce childhood diseases as well: a case in point is India, where there have been four new vaccines that were added to UIP, including vaccines against Japanese E n c e p h a l i t i s , r o t a v i r u s , r u b e l l a a n d polio (injectable).

Techno log ica l l y, i n te rms o f de l i ve ry vaccines, there is an incipient trend to move towards more thermostable formulations for vaccines to be stable out of cold chain in poorer countries.

New vaccines and associated technology will need to be developed in the future to play a critical role with existing diseases such as Malaria, AIDS or with emerging deadly diseases such as Ebola or even a potential future global threat such as pandemic influenza.


Vaccines – Enhancing Global Value and Prioritizing Safety, Efficacy and Delivery

The story of vaccines did not begin with the first vaccine – Edward Jenner’s use of material from cowpox pustules

to provide protection against smallpox. Rather, i t begins with the long history of infectious disease in humans, and in part icular, with early uses of smal lpox material to provide immunity to that disease.

Evidence exists that the Chinese employed smallpox inoculation (or variolation, as such use of smallpox material was called) as early as 1000 CE. It was practiced in Africa and Turkey as well, before it spread to Europe and the Americas.

Edward Jenner’s innovations, begun with his successful 1796 use of cowpox material to create immunity to smallpox, quickly made the practice widespread. His method underwent medica l and techno log ica l changes over the next 200 years, and eventual ly resul ted in the eradicat ion of smallpox.

Lou is Pas teur ’s 1885 rab ies vacc ine was the nex t t o make an impac t on human disease. And then, at the dawn of bacteriology, developments rapidly followed. Antitoxins and vaccines against diphtheria, tetanus, anthrax, cholera, plague, typhoid, tuberculosis, and more were developed through the 1930s.

The middle of the 20th century was an ac t ive t ime fo r vacc ine research and development. Methods for growing viruses in the laboratory led to rapid discoveries and innovations, including the creation of vaccines for polio. Researchers targeted other common childhood diseases such as measles, mumps, and rubella, and vaccines for these diseases reduced the disease burden greatly.

“Historically vaccines were produced at a relatively low price and sold with a low

The vaccine market is growing rapidly, with many new challenges including the need for vaccines to counter new emerging threats such as Ebola, Chikungunya and new pandemic influenza strains as well as to counter old enemies including HIV, TB and malaria. And some vaccine research is beginning to focus on non-infectious conditions such as addiction and allergies. Innovative techniques now drive vaccine research, with recombinant DNA technology and new delivery techniques leading scientists in new direction.

profit margin. They were add-ons to other products-mostly drugs-that pharmaceutical manufacturers were producing,” explains Neal Halsey, professor of pediatric infectious diseases and international health at Johns Hopkins Bloomberg School of Public Health. “The people working in vaccines described themselves as the stepchild of others, and they had to fight hard for the resources to develop new vaccines.”1

There are many factors that make vaccine production tricky, and thus less lucrative: Live vaccines are troublesome to manufacture, and they’re closely regulated by the FDA for quality control. Public agencies often buy vaccines at capped prices (though research has shown that doesn’t necessarily make companies exit the market, because they buy at high volumes). Altogether, a combination of high production costs, low market prices, and heavy regulation may have con t r i bu ted t o occas iona l vaccine shortages.

By now, the numbers on the recent US measles outbreak are well known. In 2014, Amer ica had more than 600 cases of measles—the highest number in 20 years. In the month of January 2015 alone, 84 people in 14 states reported having measles.

GBI research reports that companies in the vaccine sector will be competing for a slice of USD 52 billion market by 2016.

Vaccine Safety

More than two centuries have passed since the first successful vaccine for smallpox was developed. We’ve come a long way since. Today’s vaccines are among the 21st century’s most successful and cost-effective public health tools for preventing disease and death . Thanks to immunizat ions , debilitating and often fatal diseases like polio, that were once common, are now

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only distant memories. Currently there are vaccines available to protect children and adults against at least 17 diseases, which cause serious afflictions such as paralysis, loss of hearing, infertility and even death.

One o f the most impor tan t ques t ions is - what kind of studies is performed to determine that any vaccine is safe? And what ev idence is there tha t vacc ines a re espec ia l l y sa fe i n i n fan ts , sma l l children, pregnant mothers, the elderly, and those with asthma and compromised immune systems?

According to the statutes of the FDA’s Public Health Service Act, vaccine manufacturers are required to prove a vaccine complies with three cri teria before approval and launch: safety, purity and potency.

Vaccines face a tougher safety standard t h a n m o s t p h a r m a c e u t i c a l p r o d u c t s because they are given to healthy people, of ten chi ldren. What they stave off is unseen, and many of the diseases are now rare, wi th thei r effects forgot ten. Improved safety means that researchers are sometimes searching for vanishingly sma l l r i s ks . A l t hough vacc ines mus t undergo s t r ingent safe ty tes ts before distribution, technological advances have made modern vaccines purer and safer than their historical counterparts. Most developed countries have switched to the inactivated polio vaccine and stopped using whole-cel l pertussis (whooping cough) vacc ines, which are made f rom k i l led bacteria and cause relatively high rates of arm swelling, febrile convulsions and periods of limpness or unresponsiveness.2

Vaccine Bioprocessing

Va c c i n a t i o n s a r e t h e m o s t e f f e c t i v e weapons in the f ight against infectious d iseases. However, deve lop ing nove l vaccines alone is not suff ic ient to win t he ba t t l e and the deve lopmen t and m a n u f a c t u r e o f e c o n o m i c a l l y p r i c e d vaccines in sufficient quantities represent real research challenges. Swiss researchers

have developed a new bioprocess which increases the vaccine yield by a factor of fifty compared to conventional techniques.

After virus cultivation, the allantoic fluid of the egg is harvested using manual or automated vacuum systems and is then usually clarified by centrifugation to remove cellular debris. The production process will vary from manufacturer to manufacturer, but the next stages normally include a whole virus purification and concentration step and inactivation. Purification may be by zonal centrifugation on a density gradient or by column chromatography, while chemical inactivants employed include formaldehyde and betapropiolactone.

To produce the spl i t v irus and subunit vaccines the whole v i rus is subjected to d isrupt ion wi th a sur factant , which solubilizes the viral membrane. For subunit vaccines the internal subviral core of the virus is separated from the surface proteins on the basis of their differing sedimentation rates. With split virus vaccines, the choice and use of surfactant ensures that the subv i ra l co re i t se l f i s d i sassemb led . Diafi ltration normally ensues to remove surfactant and other media components from the product terminating in a sterile filtration step to yield a monovalent bulk solution. Monovalent bulk solutions of each

of the three vaccine strains are blended together a t the appropr ia te s t rength , producing the final trivalent vaccine. The quantity of immunoreactive hemagglutinin in each dose is standardized to contain the amount recommended, which is usually 15 micrograms per strain. Neuraminidase of each strain is typically not quantified but must be shown to be present in the vaccine. The vaccine may be presented in single or multi-dose vials or pre-filled syringes.

The l ive virus vaccines are formulated t o c o n t a i n 1 0 6 . 5 - 7 . 5 m e d i a n t i s s u e culture infectious doses of live attenuated influenza virus reassortant of the strains recommended by the U.S. Public Health S e r v i c e f o r t h e u p c o m i n g i n f l u e n z a season. The reassortant comprise the hemagglutinin and neuraminidase from the desired wild type strains with the remaining influenza genes originating from a “cold adapted” parent. With cold-adaptation the virus replicates efficiently at 25°C but is restricted in replication at 37-39°C. Thus the virus can replicate in the nasopharynx, thereby inducing protective immunity, but is prevented from infecting the upper and lower respiratory tract. (Source – IFPMA).

Viral harvests used in the manufacture of this vaccine are produced by inoculating each of the three reassortant seed viruses

Figure 1: Vaccine manufacturing process (Merck Millipore).


“Vaccine efficacy studies can measure outcomes beyond disease attack rates, including hospitalizations, medical visits, and costs.”

into specific pathogen-free eggs which are incubated to permit virus cultivation. The allantoic fluid of these eggs is harvested, clarified by centrifugation and stabilized with buffer containing sucrose, potassium phosphate and monosodium glutamate. Each lot of v i ra l harvest is tested for the cold adapted phenotype (can grow a t 25°C) , t he t empe ra tu re sens i t i ve phenotype (restricted replication at 37-39°C) and the a t tenuat ion phenotype (restr icted replication in the upper and lower respiratory tract of ferrets) and is also tested extensively by in vi tro and in v ivo methods fo r advent i t ious and contaminating agents. Viral harvests from the three strains (H1N1, H3N2 and B) are subsequently blended and diluted as required to the desired potency to produce trivalent bulk vaccine. The bulk vaccine is then filled directly into individual sprayers for nasal administrat ion. The sprayers are labeled and stored frozen at -15°C. (Source – IFPMA).

Innovations in Assessment of Vaccine Efficacy

Efficacy and safety of vaccine products are carefully assessed before marketing authorization by regulatory authorities is given. Pre-marketing evaluation is usually carr ied out by the way of randomized clinical trials (RCT). Populations involved in RCTs can vary greatly. The number of subjects to be enrolled in a RCT depends on several factors but it is mainly determined by the expected statistical power that the results should have in relation to specific end points (eff icacy to protect against specific severity levels of the disease.3

Va c c i n e e f f i c a c y i s b e s t m e a s u r e d by doub le -b l ind , randomized, c l in ica l controlled trials, such as those performed for both the pentavalent and monovalent rotavirus vaccines. Such vaccine efficacy trials represent the “best case scenarios” of vaccine protectiveness under controlled condit ions and are commonly required before a new vaccine is licensed by the Food and Drug Administration and other

global regulatory authorities. The outcome data (vacc ine e f f i cacy) genera l l y a re expressed as a proportionate reduction in disease attack rate (AR) between the unvaccinated (ARU) and vaccinated (ARV) study cohorts and can be calculated from the relative risk (RR) of disease among the vacc inated group wi th use o f the following formulas:

The advantages of a vaccine efficacy study include rigorous control for biases afforded by randomization, as well as prospective, active monitoring for disease attack rates and careful tracking of vaccination status; often there is, at least for a subset of the study population, laboratory confirmation of the infectious outcome of interest and a sampling of vaccine immunogenicity

Vaccine eff icacy studies can measure outcomes beyond disease attack rates, including hospitalizations, medical visits, and costs. The external val idi ty of the resul ts of a vacc ine eff icacy s tudy to a larger, nonstudy populat ion may be lowered by differences between the study cohort and the population as a whole. For example, a rotavirus vaccine might be efficacious in a study population restricted to certain inclusion and exclusion criteria but might be less effective in a population at large which is different in critical ways from the study cohort.

New Vaccine Candidates

To develop new vaccines against some of the world’s biggest killers, including HIV, malaria, and tuberculosis, scientists must be able to evaluate promising candidates.

Some of the most promis ing potent ia l vaccines are made from weakened l ive versions of the infectious agent. As a result, they cannot be studied in human tr ials unless researchers can be confident that the weakened vaccines will be safe. Vaccine researchers need improved and reliable animal tests that can help them evaluate potential vaccines before they are tested in humans.

Policy and investment decisions regarding new health technologies are often complex. They require a careful balancing of multiple perspectives and differing objectives. On some occasions, policymakers or analysts approaching these decisions have access to cost-effectiveness or cost-benefit analyses to help guide their decisions, but almost invariably such analyses are inadequate.

Recent advances in dec is ion-suppor t systems have offered ways to embed a range o f d i f fe ren t p re fe rences and parameters into formal modeling structures, known as multicriteria decision analysis. The Institute of Medicine (IOM) has released a software tool called SMART Vaccines, short for Strategic Multi-Attribute Ranking Tool for Vaccines. This early-stage prototype-the use of which needs to be evaluated by interested par t ies - i s g rounded on mu l t ia t t r i bu te utility theory.

The major challenge to develop vaccines using defined and single antigens is finding molecules able to stimulate appropriate immune responses t ha t can l ead t o resistance. However, a strategy that could accelerate the achievement of an effective vaccine would be the association of different recombinant an t igens tha t p rev ious ly resulted in partial protection or even the use of pools of antigens known as multivalent or mult iepitope vaccines. This strategy was evaluated for some researchers using

ARU-ARV ARU

Efficay = x 100

(1-PR) x 100Efficay =


associations of synthetic peptides or even DNA-based vaccines but their approach did not engender higher levels of protection when compared to the use of a single antigen. This demonstrates that no additive or synergistic effects were obtained from the different antigens selected in those s tud ies but i t cou ld be re la ted to the specific combination of antigens and/or the type of immune response resulted from this association and do not exclude the possibility of success using other antigens.5

For example - the advent of technologies that allowed large-scale studies of genes and proteins had a remarkable impact on the screening of new and potential vaccine candidates of Schistosome mansoni. Mass spectrometry- (MS-) based proteomics, transcriptome, and genome of S. mansoni offered a vast repertoire of potential targets for vaccine and drug therapies. Despite this possibility to generate information about DNA and protein sequences, it remains an obstacle how to select them and which molecules would have the highest potential among thousands or hundreds of potential candidates. In this postgenomic scenario, bioinformatic technologies have emerged as important tools to mine transcriptomic, g e n o m i c , a n d p r o t e o m i c d a t a b a s e s . These new approaches have the potential to accelerate the ident i f icat ion of new generation of vaccine candidates that may induce greater protection than the previous schistosome ant igens studied to date. Specific algorithms allow the identification of molecules containing transmembrane domains, signal peptides, signal anchors, and other posttranslational modifications that can be used as predictors of excretory-secretory products or components exposed to the surface of the S. mansoni tegument.5

Vaccine Delivery Technologies

Today, most vaccines are delivered via in t ramuscular or subcutaneous routes using a needle and syringe. In the future, novel delivery technologies may enhance the reliability and effectiveness of vaccines, while also improving the safety of delivery.

Additionally, methods such as intradermal del ivery hold promise for reducing the quantity of vaccine required for an effective dose-potentially helping to decrease costs for immunization programs.

Second, although in the past most vaccines have been designed to stimulate antibody responses aga ins t sur face molecu les of bacter ia or viruses, new generat ion vaccines are increasingly designed to elicit cel lu lar immune responses, especial ly o f the Th1 type. Such responses are considered paramount for targeting chronic in fect ious d iseases that may have an intracellular stage (associated for example with HIV1, herpes viruses, hepat i t is C virus, Hel icobacter pylor i , Plasmodium falciparum, Mycobacterium tuberculosis), but also for the development of therapeutic vacc ines against cancer, auto immune diseases or allergies. New vaccines are also being developed to elicit mucosal immune responses in humans, for example to protect against pathogens such as influenza virus, HIV1, HSV or human oncogenic or wart-associated papilloma viruses. Unlike most of the tradit ional vaccines, these efforts require the recruitment of cellular or mucosal immune effector mechanisms and necessitate the exploration of new routes of administration, new formulations, and new adjuvant systems. Third, improving vaccine administration generally, either for the physician, or more importantly for the customer, towards pain-free and safe needle-less devices is likely to represent a major driver in the future vaccine market.6

Vaccination and Quality of Life

Va c c i n a t i o n i s o n e o f t h e g r e a t e s t breakthroughs in modern medicine. No o the r med ica l i n te rven t i on has done more to save lives and improve quality of life. There will be many more potentially lifesaving vaccines in the years to come. Research is thriving, with more than 150 new vaccines currently being tested.

Investment in research and development, largely by the pharmaceutical industry,

has resulted in a broad range of vaccines targeting over 25 infectious diseases.

During the last 30 years scientists have made further breakthroughs by harnessing the power o f b io techno logy, gene t i c decoding and in format ion technology, and the pace of vaccine development has accelerated. As a consequence, the vaccine industry has recently introduced a number of new vaccines such as those against cervical cancer (human papillomavirus), meningococcal infection, pandemic-potential influenza, pneumococcal diseases, rotavirus diarrhea and varicella zoster.

We will soon have an improved pneumococcal vaccine that offers protection against more strains of the disease, a new meningitis B vaccine for babies and there’s promising work on longer-lasting vaccines against flu. As Edward Jenner said - The deviation of man from the state in which he was originally placed by nature seems to have proved to him a prolific source of diseases.

References

1) Bourree Lam, Vaccines are profitable, so what? The Atlantic, 2015.

2) Roberta Kwok. The real issues in vaccine safety. Nature, 473, 436-438, 2011.

3) Pier Luigi Lopalco, Assessing Vaccines and Vaccination Programmes in the Field, Italian Journal of Public Health. 2009.

4) Geoffrey A. Weinberg and Peter G. Szilagyi, Vaccine Epidemiology: Efficacy,

Effectiveness and the Translational Research Roadmap. Volume 201, Issue 11, P 1607-1610, 2010.

5) Carina S. Pinheiro, Computational Vaccinology: An Important Strategy to Discover New Potential S. mansoni Vaccine Candidates. Journal of Biomedicine and Biotechnology. 2011.

6) Philippe Moingeon, Charles de Taisne and Jeffrey Almond, Delivery technologies for human vaccines, British Medical Bulletin, 2002.

Contact:[email protected]


Molecular Pharming in Plants for Vaccines

Vaccine development today requires a n a s s o r t m e n t o f i n n o v a t i v e techno log ies tha t can address

many of the wor ld ’s most chal lenging pub l i c hea l th i ssues . Of these , p lan t derived pharmaceuticals have slowly but steadily progressed out from the sidelines and into real time. With the race for novel vaccines and therapeutic agents to combat emerging and difficult-to-treat infectious diseases and cancers, it is not surprising that p lant-based expression p lat forms are f inal ly coming into the forefront of research and development.

T h e r e c e n t u s e o f t h e d r u g Z M a p p , composed of a trio of monoclonal antibodies and der ived f rom tobacco plants, was developed by Mapp Biopharmaceutical, Inc. and used to t reat Ebola pat ients. ZMapp is one current example of the immediate and pressing roles that plant-based vaccines are now ready to take on. This article focuses on the current state of plant derived vaccine development and its role in remolding the pharmaceutical industry to better address diseases not only pertaining to industrialized countries, but also of the world’s rural poor.

P lant made vacc ines and therapeut ic agents such as monoclonal ant ibodies have been developed as tools for the past two decades, initially in academic settings, but more recently within the corporate arena. With developing countries in mind, much of the research and development has progressed with complete freedom to operate and with as few intel lectual property barriers as possible. Plants were chosen to develop as pharmaceut ica l bioreactors for a number of compell ing reasons . P lan t -de r i ved b io log i cs a re eff icacious, safe and easy to produce en masse. Pharmaceut ica ls that have been grown in plants offer new answers to the constant chal lenge of providing

In this article, author describes the emerging role of plant molecular pharming as a promising technology for the manufacture of pharmaceutical products indicated for chronic and infectious diseases.

medicines which can survive at ambient temperatures, are inexpensive and are t ranspor tab le to remote pa r t s o f t he world, often without a well- established medical infrastructure. This init ial drive paved the way for other opportunities for the use of plant-based vaccines, with a breadth of scope that includes providing vaccines against global pandemics such as influenza virus to large-scale protection aga ins t po ten t i a l b i owar fa re agen ts , and even to the newly promising field of personalized medicine.

Although the first vaccines were originally expressed from transgenic plants, the field has moved rapidly toward the use of plant virus expression vectors for optimal e x p r e s s i o n l e v e l s . W h i l e t r a n s g e n i c plants have the dual advantage of stably producing the antigen in question as well as generating seed, which can be stored for future growth, they also have several drawbacks. For example, transgenic plant product ion requires t issue cul ture and plant regeneration procedures which can be lengthy, and publ ic perception over GMO technologies remains a contentious, highly politicized issue.

The util ization of plant virus expression vectors , on the o ther hand, does not require the use of GMO technology; rather, recombinant viruses can be used to infect large numbers of conventionally grown plants or plant cell culture. These virus vectors have been designed with their movement and coat proteins removed, thus disabling the virus from spreading to unwanted plants or weedy relatives. The infection process is extremely rapid, and depending on the plant virus/host system used, can take a few days to a little over a week for large amounts of the desired protein to accumulate. Moreover, the yield of vaccine protein that can be generated by infecting plants with recombinant virus

Kathleen HefferonUniversity of TorontoToronto, Canada


vectors can be much greater than what is achieved by expressing the vaccine via transgenic plants. Furthermore, plant virus vectors can be introduced by exposing the target plant to a vacuum and infiltrating every leaf with a suspension of Agrobacterium harboring the virus expression vector. In this way, every plant cell can be infected synchronously, so that expression of the vaccine protein can be optimized for a given system.

Plant virus expression systems have been developed based on positive sense RNA viruses such as the well characterized, rod-shaped Tobacco Mosaic Virus (TMV), the icosahedral bipartite RNA virus Cowpea Mosaic Virus (CPMV) and single- stranded DNA geminiviruses such as Tobacco Yellow Dwarf Virus (TYDV). Each of these vectors has been ‘deconstructed’ into its essential genomic components required for replication, to simplify cloning and expression strategies.

These vector systems based on p lant virus vectors have been commercialized and are available for use. For example, the MagnICON vector system of ICON Genetics is based on a TMV vector and has been developed for the high expression of biopharmaceuticals and industrial proteins. TMV has also been developed as a vector by Fraunhofer USA to generate a vaccine against H1N1 influenza virus. Similarly, Medicago, Inc., has expressed pandemic flu virus antigens on the surface of CPMV virus-like particles (VLPs). Clinical trials for both Fraunhofer and Medicago’s flu vaccines are currently well underway.

These up and coming plant virus-based expression platforms have been in the pipelines for years and are well known to those in the field, however, the efforts of ZMapp to combat the Ebola epidemic have brought the technologies into the spotlight and under public scrutiny. ZMapp consists of a combination of monoclonal antibodies that were generated in tobacco plants at Kentucky Bioprocessing, LLC., using the TMV expression strategy described above. Al though the drug had not yet entered c l in ica l t r ia ls , i t was used to treat a few infected patients during the Ebola outbreak in West Africa in 2014. Deve lopment o f the drug was funded b y t h e D e f e n s e A d v a n c e d R e s e a r c h Pro jec ts Agency (DARPA) o f the US. ZMapp brought the potent ia l of p lant-based vaccines and pharmaceuticals to combat emerging diseases into the front and center.

While plant-based vaccines will be more efficacious, faster and cheaper to produce in the future, there will certainly be hurdles to overcome, as there are with all new vaccine strategies. Today, vaccines and other biopharmaceuticals based on plant expression vectors offer an alternative approach that could make a signif icant impact the world over. Importantly, the net effect of that impact could influence and improve the lives of the some of the poorest people on the planet. Watching more and more plant-made vaccines enter the marketp lace, as wi l l happen overthe nex t few years , w i l l there fore be something that the whole world can look forward to.

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Considerations while Selecting Peptones for Biotechnology Applications

Peptones are part ia l ly hydrolysed p ro te in p repa ra t i ons . The te rm ‘ p e p t o n e ’ m o s t o f t e n r e f e r s t o

hydrolysed proteins produced by enzyme digestion, however it is also used more l o o s e l y t o d e s c r i b e a c i d h y d r o l y s e d proteins and extracts. Peptones contain a mixture of peptides and amino acids, and the s i ze and compos i t i on o f the components can vary widely.

S o m e p e p t o n e s m a y i n c l u d e h i g h m o l e c u l a r w e i g h t p e p t i d e f r a g m e n t s greater than 3,000 Daltons, while products o f ac id hydro lys is a re more l i ke ly to be of low molecular weight. The key to appropriate sourcing lies in understanding that products from the same raw material source but from different manufacturers - o r e v e n d i f f e r e n t g r a d e s f r o m t h e same manu fac tu re r – a re sub jec t t o considerable variability in their molecular weight profi les. Consequently, they wil l behave differently in a given proces

Why Enzyme Digestion?

In comparison with alternative methods of hydrolysing proteins, enzyme digestion allows greater control of the process and has the particular advantage that it does not denature amino acids or v i tamins. Enzyme d igest ion c leaves prote ins at speci f ic amino acid si tes, producing a mixture of free amino acids and peptides. It also takes place at moderate temperatures (around 30oC), avoiding the risk of non-specific thermal degradation.

The process is however relatively slow and demands a r igorous approach to r a w m a t e r i a l s e l e c t i o n a n d p r o c e s s cleanliness. Without this rigour, microbial growth and contamination with endotoxins and other by-products is a danger.

Peptones are a cost-efficient source of growth-promoting nutrients and are used in a variety of microbial fermentation and mammalian cell culture applications. Peptones have also been proven to help reduce end-product variability and increase vaccine yield. In today’s markets there are many sources of peptones, sometimes traded simply as commodities. Ensuring quality and consistency for bioprocessing can be a challenge. This article discusses some key considerations when selecting a peptone product for a specific application.

What Acid Hydrolysis Offers?

Acid hydrolysis is an inexpensive method of producing protein hydrolysates that is faster than enzymat ic methods and therefore less prone to microbial growth. I t is though a moderately severe, non-spec i f i c p rocess t ha t can c l eave a l l pept ide bonds in a protein ’s structure as well as destroying some of the amino acid residues present. Serine, cystine, th reon ine and t ryp tophan may a l l be lost as a result of acid hydrolysis, and convers ion o f asparag ine to aspar t i c acid and glutamine to glutamic acid also occurs . The necessary neut ra l i sa t ion processes can also result in hydrolysates containing high concentrations of salt.

W h i l e a c i d h y d r o l y s e d p r o t e i n s a r e commonly used in microbiological culture media, peptones are generally preferred for biotechnology applications.

Use of Alkali Hydrolysis

Alkali hydrolysis is also used to produce protein hydrolysates, sometimes as a pre-treatment for acid or enzymatic hydrolysis. Complete protein hydrolysis using alkali me thods can , however, resu l t i n t he destruction of cysteine, serine, threonine and arginine.

What is Meant by Extract?

T h e t e r m ‘ e x t r a c t ’ - y e a s t o r b e e f extract for example - is sometimes used in terchangeably wi th ‘peptone’ . I f the extraction process uses proteases, then the extracts are t rue peptones. Some yeast extracts are produced by autolysis, a process whereby the yeast cel ls are broken down by their own intracel lular enzymes when the cells die. The resulting

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products are different from those found in trypsin digested yeast for example.

The Importance of Feedstocks

A wide variety of feedstocks are used in the production of protein hydrolysates. They include raw materials as diverse as casein, lactalbumen, baker ’s yeast, meat, animal organs, soy, wheat, rice, pea and cottonseed. The resulting peptones contain proteinaceous material, but it is important to understand that there will also be non-proteinaceous elements including cell constituents such as carbohydrates, nucleic acids and lipids. These can make up as much as 30 per cent of the peptone’s dry weight.

Another signif icant consideration when selecting raw materials is that some have a high bioburden, potent ia l ly resul t ing in the presence of tox ic bacter ia l by-products including endotoxins. Endotoxins can a f f ec t ce l l g row th , espec ia l l y i n m a m m a l i a n c e l l c u l t u r e s , a n d present a r isk of contaminat ion of the p r o d u c t ( v a c c i n e , f o r e x a m p l e ) i n downstream processing.

Peptones fo r mammal ian ce l l cu l tu re s h o u l d b e t h o r o u g h l y t e s t e d f o r t h e presence of endotoxins.

Applications and Economic Benefits of Peptones

Peptones for mammalian cel l cul ture : In mammalian cell culture, peptones are used to replace or supplement amino acids, bovine serum or foetal calf serum ( F C S ) . To d a y ’s g r o w i n g d e m a n d f o r peptones reflects their potential to deliver both cost savings and increased yields, and the current challenges in sourcing TSE-free FCS.

T h e r e p o r t e d a b i l i t y o f p e p t o n e s t o increase yields (sometimes by more than 100 per cent) , compared wi th def ined media in vaccine and antibody production involving mammalian cel ls, is not ful ly understood. Some aspects have been

studied and the effect is not due to the amino acid content alone. I t has been proposed that the var ious non-pept ide extracts present as by-products in some peptones are nutr i t ious to cel ls. Small peptides present in growth media have also been shown to promote higher yields of expressed proteins compared with the corresponding pure amino acids.

In a study by Paspulet i et al 1, feeding cells with tetra-alanine resulted in fewer cells but a 25 per cent higher antibody yield, compared with using free alanine. Feeding cells with a tripeptide of glycine and lysine (Gly-Lys-Gly) gave much slower ce l l g rowth and a 66 per cent h igher monoclonal antibody yield than feeding with the corresponding free amino acids.

The cells fed with amino acids began to die after only four days, whereas the cells fed with the tripeptide were stil l growing after 14 days. Cell death is undesirable because cel l contents and breakdown products become concentrated in the supernatant requir ing their removal in downstream processing, and are ultimately toxic to the remaining live cells.

Example of supplementing mammalian cell culture with known peptone: The effect of supplementing a mammalian growth medium with peptones is exemplified in the following. BME (Basal Medium Eagle) was supp lemented w i th FMV (Foot & Mouth Vaccine) peptone (Lab M Ltd, UK) and FCS. Cell counts were performed at day four. Supplementation was shown to be optimal at 5 g/L of FMV peptone.

I n summary, t he use o f pep tones i n mammal ian ce l l cu l tu re can inc rease y ie lds o f expressed p ro te ins , reduce media costs and lower the levels of cell necrosis products in the supernatant.

“Endotoxins can affect cell growth, especially in mammalian cell cultures, and present a risk of contamination of the product in downstream processing.”


Peptones for classical and recombinant fermentation: In microbial fermentation, peptones are a source of nitrogen, amino ac ids and o the r nu t r i en t s . Se lec t i ng peptones for their ease of use, effect on cell metabolism and impact on downstream processing can reduce production costs and maximise yield.

This applies to the microbial production of bulk fermentation products, such as enzymes and amino acids, and for the biotransformation of precursor substrates. Recomb inan t and b i opha rmaceu t i ca l p r o d u c t s h a v e p r e d o m i n a n t l y u s e d fermentat ion media containing casein-based peptone digests but the trend now is for peptones of non-animal origin.

Peptones for microbial vaccine production: Producing live vaccines requires cultivation of live attenuated and immunogenic strains of the original pathogenic organism. For inac t iva ted who le ce l l vacc ines good b iomass product ion is necessary. For s u b - c o m p o n e n t v a c c i n e s , h i g h - l e v e l expression of the component is needed. W i t h m e t a b o l i t e v a c c i n e s , e f f i c i e n t expression of pathogenic i ty factors is crucial.

Historically, proteose peptone (enzymic digests of peptone) and acid hydrolysed c a s e i n h a v e b e e n u s e d t o e n h a n c e p r o d u c t i o n o f b a c t e r i a l t o x i n s i n fermentation cultures. Selecting peptones with low iron content has been shown to s i gn i f i can t l y imp rove t he y i e l d o f several such toxins. High levels of toxin p roduc t i on have a l so been ach ieved with vegetable peptones, such as those based on enzymatic digests of soy. Using peptones in microbial fermentation can increase yields of expressed proteins and increase biomass.

Choosing Peptones for Biotechnology

T h e r e a r e a n u m b e r o f s p e c i f i c requirements for peptones intended for

use in biotechnology applications. They shou ld be f r om a ce r t i f i ed TSE- f r ee source, be low in endotoxins and exhibit good cell growth and viability, as well as good reproducibility.

The issue of endotoxins is critical. Not only do they inhibit the growth of mammalian cells, they cause pyrogenic reactions in animals or humans if not removed from the vaccine product during downstream process ing. Ideal ly mammal ian t issue culture grade peptones wi l l have been tested to ensure endotoxin levels below 4 EU/mL for a 20 g/L solution (2 per cent).

The FDA provides guidance for industry on the ‘Characterization and Qualification of Cell Substrates and Other Biological Ma te r i a l s Used i n t he P roduc t i on o f Vi ra l Vacc ines for In fec t ious Disease Indications’. Materials used in the culture of cell l ines for human vaccine production should be shown to be free of adventitious agents ( in fect ious agents and TSEs) . The onus is on the vaccine producer to demonstrate compliance.

The European Directorate for the Quality o f Medic ines (EDQM) Cer t i f i ca t ion o f Substances Division issues certificates of suitability to the European Pharmacopeia

general chapter 5.28 and the monograph of ‘Products with risk of transmitting agents of animal spongiform encephalopathies no. 1483 of the European Pharmacopoeia’2.

M i c r o b i o l o g i c a l t e s t i n g i s h e l p f u l i n demonstrat ing a low b ioburden in the dehydrated peptone. Some manufacturers hea t t rea t t he raw mate r ia l s t o food standards as a precaution.

F o r e x a m p l e , E U D i r e c t i v e C h a p t e r 1 o f Annex C t o D i r ec t i ve 92 /46 /EC re la t ing to the heat t reatment o f mi lk has been appl ied to raw mater ia ls for casein peptones. The term “tissue culture tested” usual ly refers to the test ing of ready-prepared steri le l iquid media for the presence of Mycoplasma. I t is not relevant to dehydrated peptones as they are steril ised before use.

Importance of Screening

Selec t ing peptones for b io techno logy applications is best done by screening p r o d u c t s f r o m r e p u t a b l e s u p p l i e r s . Peptones f rom di fferent raw mater ia ls contain different ratios of amino acids, and wil l also contain other substances. Even when comparing the same types of peptones from di fferent manufacturers

Pharma Bio World February 2015 33

there will be variations in the composition and molecular weight of peptides simply because of the different enzymes and/or processes used in production.

Manufacturers may provide amino acid p ro f i les , bu t these are o f ten ‘ t yp ica l ’ values rather relating to a specific batch. The amino acid profile is a characteristic property of the protein raw material and is reasonably consistent for good quality raw materials. Generally, it is not necessary to ana lyse the amino ac id pro f i le fo r each batch of peptone, prov ided that the peptones are of high quality. Some manufacturers may provide amino acid analyses for each batch at extra cost. The end user can then supplement the medium with indiv idual amino acids where the peptone is deficient in one or more amino acids, or a blend of several peptones may be used.

A cel l growth assay is a usefu l guide to compat ib i l i t y. Th is can screen ou t peptones that contain components that are inhibitory or toxic to cells. An important po in t t o no te i s t ha t wh i l e pep tones intended for use in microbial culture media may sometimes give good performance in mammalian cel l culture, batch-to-batch var iat ions that are of no consequence in microbial culture can have profound effects on mammalian cells.

Concentration Matters

P e p t o n e s b e c o m e i n h i b i t o r y a t h i g h concen t ra t ions . When used in med ia supplemented with serum and/or amino a c i d s t h e y a r e a d d i n g t o t h e a m i n o acid and peptide concentration already present . In the example c i ted above, where the medium contained 5 per cent FCS, the cell growth performance reduced at peptone concentrations above 5 g/L. The same peptones have demonstrated peak ce l l g row th i n o the r t es t s a t a concentration of 20 g/L.

Th e o p t i mum pep tone concen t ra t i on d e p e n d s u p o n a n u m b e r o f f a c t o r s : the cel l l ine, the base medium, serum supplementat ion and peptone type. As a guide, cell growth screening over the range 1-20 g /L o f peptone shou ld be sufficient, although optimal performance may lie outside this range for some media and some processes.

It is clear that the peptone supplementation giving the highest rate of cell growth does not always give the best product yield. Ultimately, the best yield may be achieved with a blend that provides a balanced mix of amino acids, small peptides and other biochemicals.

Batch-to-batch Performance

Even the best peptones cannot approach the reproducibility of chemically-defined media because the natural raw materials used in their production are inherently var iab le. Prote in hydro lysates have a var iety of industr ia l uses so peptones are often traded as a bulk commodity. Peptones for fermentation or cell culture need to be of consistent high quality so it is advisable to source from suppliers who offer microbial or cell culture grades manufactured in GMP facilities.

It is also worth noting that microbial culture grades may not be suitable for mammalian cell culture. Also any peptones with high sodium or sa l t leve ls are l ike ly to be acid hydrolysates not peptones and that peptones from different manufacturers, even premium grades, are usual ly not completely interchangeable.

Va l i d a t i n g t h e p e p t o n e i n y o u r o w n process is important as peptones that

work in one production process may not be optimal for another, even if the cell l ine or organism appears s imi lar. And f inally, the fact that a particular peptone is a premium product is often reflected in i ts higher price.

Conclusions

Peptones can supp lement o r rep lace am ino ac ids and se rum in i ndus t r i a l fermentation and cell culture applications, while providing lower cost and sometimes higher product yields. For secure culture and re l iab le y ie lds , i t i s impor tant to always specify peptones from reputable supp l i e r s , manu fac tu red unde r GMP condit ions and from materials that are certif ied TSE-free and low in endotoxins.

I t i s sa fe r to use the manufac tu re r ’s r e c o m m e n d e d g r a d e s f o r m i c r o b i a l and mammal ian ce l l cu l ture.Peptones intended for microbial culture may give poor or inconsistent results i f used for mammalian cell culture. Mammalian cell culture peptones that have been culture tested offer addit ional assurance.

References

1) Paspulet i ,V. K. & Demain, A. L. (eds). (2010) Protein Hydrolysates in Biotechnology. Springer Science and Business Media B.V., The Netherlands2) European Directorate for the Qual i ty of Medicines. Products with r isk of transmitt ing agents of animal spongiform encephalopathies. Monograph no. 1483 of the: http://www.edqm.eu/en/certi f ication-background-77.html [Accessed 17 Sep 2014]


“The optimum peptone concentration depends upon a number of factors: the cell line, the base medium, serum supplementation and peptone type.”


The Future of Pharmaceutical Processing & Packaging

In c r e a s i n g h e a l t h c a r e c o s t s , n e w legis lat ion and expir ing patents cal l f o r dec is i ve changes in the g loba l

pharmaceutical industry. New markets for specialty medicines, biopharmaceuticals and biosimilars are opening up, entailing oppor tun i t ies fo r fu r ther g rowth . The coming years will see markets across the globe implement new best practices and manufacturing concepts. What they all have in common is the need for safe, high-quality and consistent operations.

Having left the best part of the generic patent cliff behind, the patents of several large, biotech molecules are now about to expire, opening the doors for biosimilar production. Biopharmaceuticals and their successors all require intensive research and development, as well as sophisticated equipment and contaminat ion-free raw materials. Moreover, the use of high-potency pharmaceuticals has grown extensively, causing manufacturers to pay more heed to protecting all elements of the supply chain from their potentially harmful effects.

Due to ever-stricter guidelines for aseptic filling operations, manufacturers increasingly re ly on the use of isolators to reduce human contact with products. Compared to convent ional c leanroom product ion, isolators offer higher product quality, lower operat ing costs and signif icant energy savings, as well as a safe accomplishment of longer production cycles. The development of ready-to-fill sterile primary packaging sys tems in coopera t i on w i th l ead ing equipment manufacturers has improved aseptic filling operations and paved the way for the development of new, highly flexible filling and closing machines designed to handle pre-sterilized nested syringes, vials and cartridges.

Manufacturers of solid dosage forms have also recognized the need for containment solutions. They require closed containers or biological cabinets, and the use of rooms with specially designed air handling and

Which major trends will shape the future of pharmaceutical processing and packaging operations? This article detects some major trends and explains what they mean for equipment manufacturers.

secure operating procedures. Some drug manufacturers have already built entire containment facilities, where building and equipment are optimally fine-tuned to one another. Involving the equipment supplier at an early planning stage ensures flexible, modular and space-saving solutions.

A concept that benefits this approach is continuous processing. Adopted by other industries many years ago, pharmaceutical c o m p a n i e s o n l y r e c e n t l y s t a r t e d t o apprehend the benef i ts o f cont inuous processing in terms of cost, time, space and material savings. As opposed to batch manufactur ing, cont inuous processing impl ies manufactur ing and processing materials without interruption. This concept will only work if it is based on a thorough understanding of the process interaction between the different unit operations. The FDA, for instance, st rongly advocates continuous processing and has pointed out that the approach is consistent with the agency’s Quality by Design (QbD) efforts.

QbD a ims at def in ing the qual i ty and e f f i c i e n c y o f a p r o d u c t b e f o r e i t i s manufactured, and considers Process Analyt ical Technology (PAT) – bui lding q u a l i t y i n t o p r o d u c t s d u r i n g t h e manufacturing process – as an integral part of QbD. With a comprehensive control strategy for material , process and end product, these approaches can lead to reduced product loss, less product ion f luctuat ions and faster t ime-to-market. When the FDA issued its PAT guidance in 2004, it triggered the development of new technologies for the in-line elimination of variable product quality. Novel inspection d e v i c e s , f o r i n s t a n c e f o r c a p s u l e s , simultaneously inspect all quality features like weight, foreign particles and length in real-time and at high throughput rates.

Secondary packaging and end-of - l ine equ ipmen t a l so p lay a ma jo r ro le i n ensuring pharmaceutical product quality. Many countries are currently developing

Dr Johannes RauschnabelChief Pharma Expert at Bosch Packaging Technology


and imp lement ing new gu idance and legislation to implement serialization codes for pharmaceuticals. The European Union’s Directive 2011/62/EU (Falsified Medicines Directive), to name only one of the many

i m p o r t a n t l e g i s l a t i v e d e v e l o p m e n t s , stipulates the implementation of uniquely coded, ser ia l ized packs for a lmost a l l prescr ip t ion drugs, whi le at the same t ime demanding tamper-proof closures

that indicate whether a package has been previously opened or tampered with.

Pharmaceutical manufacturers are facing major cha l lenges to imp lement these regulations in time. They must establish new procedures for the management and storage of serial numbers, which in turn requires the adaptation of highly sophisticated packaging processes in line with global strategies. This calls for a complex software architecture that will integrate the serial numbers consistently on all levels – from devices, line processes and line management to production and en te rp r i se con t ro l . A mu l t i - l aye r and modular machine and software concept is obviously the safest option. It must be compatible with exist ing l ine concepts, allowing for the development of a complete system that complies with the industry’s overall demand for safe, high-quality and consistent operations.


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Best Practices in Coding Innovative Pharmaceutical Packaging

After a long period of industrialized e c o n o m i e s ’ d o m i n a t i o n o f t h e p h a r m a c e u t i c a l m a r k e t , t h e

emerging countries are outgrowing their developed peers. The rapid ly growing demand for medicines in Africa, Asia and Latin America (dubbed as “pharmerging economies” by IMS Health) is a fact that has to be addressed by the packaging indust ry. Creat ing packaging that wi l l resonate in the local market is cr i t ical to success in emerging markets. This is driving innovation in packaging, and in turn coding and marking technologies, presenting pharmaceutical manufacturers with more options than ever. However, a s u c c e s s f u l g l o b a l p h a r m a c e u t i c a l expansion strategy is built on a foundation of best pract ices that wi l l help ensure products are safe to use for pat ients across the globe.

A longs ide the i r i nc reas ing economic weal th is a notable r ise in heal thcare s p e n d i n g a m o n g e m e r g i n g m a r k e t s . Investments in the health care system, made by government, non-governmental o r g a n i z a t i o n s ( N G O s ) a n d p r i v a t e sec to r a re fue l l i ng the g rowth o f the pharmaceutical market. The combination o f s t r e n g t h e n i n g e c o n o m i e s a n d a n e x p a n d i n g m i d d l e c l a s s i s t h e m a i n stimulator for pharmaceutical expansion. By 2016, pharmaceutical spending in Asia Pacific is expected to grow at a12.5 per cent compound annual growth rate (CAGR) through 2016, followed by Africa at 10.6 per cent and Latin America at 10.5 per cent over the same period. At the same time the developed markets of North America, Europe, and Japan will see more modest s ing le-d ig i t spending growth between 2014 and 2017 (Source: IMS Heal th) . The g l oba l f ocus on pha rmaceu t i ca l expansion in emerging markets is driving an urgent need for global serialization and traceability, to secure both supply chain integrity and patients’ safety.

This article discusses the importance of coding in pharmaceutical packaging, especially in the areas of Africa, Asia and Latin America (the emerging markets) where the demand for medicines has grew rapidly.

Coding is Fundamental

With total global spending on medicines projected to reach over USD 1 tr i l l ion b y 2 0 1 7 ( S o u r c e : I M S H e a l t h ) , t h e demand for s tandardized ser ia l izat ion of pharmaceut ical packaging becomes a crucial matter. At the moment, most industrialized economies are strengthening their legislation relating to the preventing falsification of pharmaceutical packaging and p ro tec t i on o f pa t i en ts ’ sa fe ty. I t i s a U S D 7 - b i l l i o n p r o b l e m f o r t h e pharmaceutical industry with thousands of packaging l ines needing to change. Yet without precision coding and marking t echno logy, se r i a l i za t i on e f f o r t s w i l l b e i n e f f e c t i v e a n d , i n w o r s t c a s e s , can lead to cost ly product recal ls and potential fines. Therefore pharmaceutical packaging manufacturers invest ing in “pharmerging” markets have to be aware of the challenges lying ahead and secure their business by implementing the latest coding and marking technologies.

Pharmerging Packaging Growth

C o r r e c t p r o d u c t c o d i n g i s v i t a l f o r pharmaceutical packaging manufacturers – large and smal l – in terested in the emerging markets. The latest technologies available on the market enable companies to embrace more innovative packaging so lu t ions by expand ing the i r p roduc t portfolio, both in the range of materials used and in product ion eff ic iency. For example b l is ter packs are the fastest growing package type in pharmerging markets due to product protection, patient compl iance, and suppor t o f da i ly and weekly dosages.

At the moment coding technologies are applied primarily on secondary packaging (eg, cartons), but the market is expressing a growing interest in coding on primary

Richard NemesiGlobal Vertical Manager for Pharmaceutical and Medical Devices, Videojet


packaging, such as b l is ters. As such, a range of pr in t ing so lut ions are now available to code both types of packaging, however, manufacturers need to consider the substrate characteristics and available print area first when selecting the right techno logy. Subst ra te charac ter is t i cs as wel l as upt ime and code resolut ion r e q u i r e m e n t s c a n a l l i m p a c t w h i c h print ing solut ion is optimal for a given serialization initiative.

Successful Printing for Track and Trace

A f t e r e n s u r i n g a p p r o p r i a t e p r i n t i n g capabi l i t ies, the next step is capturing p roduc t i n fo rma t i on ( such as dev i ce and production identif iers) so it can be t racked th roughout the supp ly cha in . Stable product control is vital to avoid false rejects. Two different methods are considered best pract ice: in tegrat ing the Print & Inspect system directly into t he ca r tone r o r t h rough a ded i ca ted transport system.

A compl imentary s t ra tegy is requ i red to manage the vas t a r ray o f p roduc t information created throughout the supply cha in . Th is can be ach ieved th rough aggregat ion, where un ique codes are created on outer packaging that is linked to all the units within. Aggregation avoids the opening of cases and scanning while the products are moving across the supply chain. Downstream in the supply chain, when a case or pallet code is read, an inference is made that all the individual units linked to the outer case are contained inside. Obviously this makes code quality and data integrity paramount. In order to aggregate cartons/bottles into cases, the serial number reading should be coded at the last possible moment, preferably once the product is already inside the case, to guarantee data integrity.

F ina l l y, the manufac tu re r shou ld use a u t h o r i t a t i v e d a t a s o u r c e s , s u c h a s manufacturing execution systems (MES), supervisory control and data acquisition (SCADA), enterprise resource planning (ERP) or similar. This way the company ensures that proper information is pulled to the pr in ter automat ica l ly when the job is selected. According to UPS report (“Pain in the Chain” 2013), 56 per cent of healthcare companies have found that IT investments, including bar coding and e-pedigree technology, have helped them to successfully address product security.

Flexibility is the Key

S i n c e t h e g l o b a l t r a c k a n d t r a c e ser ia l i za t ion regu la t ions are evo lv ing

constant ly ( inc lud ing Lat in and Nor th America, South-East Asia and Europe), careful consideration of the local market is key to success. Pharmaceutical packaging manufacturers must invest in a printing solution capable of addressing today and tomorrow’s regulatory demands, as well as specific local needs. Given the rapid growth and uncertain regulatory future, the chosen printing solution should be flexible to make the producer ’s l i fe easier. Ideally, your technology provider will offer an operator-f r iendly standard inter face compat ib le across pr in t ing technolog ies that can simpl i fy user experience regardless of technology. As 50-70 per cent of coding errors result from incorrect data entry, a centralized message management removes the task of message creation from the l ine, and helps ensure the r ight codes get on the right products. Therefore the right printer can be a productivity driver in the face of growing complexity of global pharmaceutical market.


“The global focus on pharmaceutical expansion in emerging markets is driving an urgent need for global serialization and traceability, to secure both supply chain integrity and patients’ safety.”


guest column

Budget 2015: Wish List for the Pharma Sector With union budget 2015 at hand, the pharmaceutical industry has immense expectation from the finance minister. This article wraps up the domestic pharmaceutical industry’s hopes and recommendations for the budget 2015.

The recent times have witnessed a sustained effort by the government to push India as a value proposition

for global manufacturers. This trend is perhaps best exhibited by the ‘Make in India’ campaign which signifies a gradual shift of focus from the services sector to the manufacturing sector. In this backdrop, the importance of the domestic pharmaceutical sector as the top science and innovation based sector, job provider and revenue generator cannot be overemphasised.

The domestic pharmaceutical industry, which is presently valued at USD 25.87 billion is expected to grow at a compounded annual growth rate of 14 per cent to reach a turnover of USD 47.06 bi l l ion by the year 2018 spurred by aggressive rural penetrat ion by drug makers, increased gove rnmen t spend ing on hea l t h and growing health awareness among people. Needless to say that this projected growth s to ry w i l l requ i re s ign i f i can t a id and assistance from the government.

With the hope that the government takes note of the immense potential that the pharma sector possesses, we have listed down some of the key measures which form part of the domestic pharma industry’s wish list for the 2015 budget.

Policy Measures

> In line with the recommendation of the expert commit tee on Universal Heal th Coverage under the chairmanship of Dr K Srinath Reddy, the government may increase public expenditure on healthcare to 2-3 per cent of the GDP. In the past such measures have been undertaken. eg, in 2005, the government introduced the National Rural Health Mission to improve healthcare delivery in 18 high-focus states. This increase in public expenditure wil l

result in an expansion of the healthcare sector, increasing the recourse to medical aid by the populace and the consequent expansion of the pharma sector.• Recent news reports have suggested

that the Ministry of Health and Family Welfare’s budget allocation is likely to face a massive cut of ` 6,000 crore on account of non-utilisation of its previous budgetary a l locat ion. However, the Minister of Health and Family Welfare had assured that no flagship programme will be affected due to such cut. In the backdrop of such suggestions, it is hoped that the government doesn’t reduce the budgetary allocation but rather work on proper utilisation of the same.

> As i t is essent ia l that Ind ia should preserve i ts image as a manufacturer of quality pharmaceutical products, the government should introduce measures to assist upgradation of small and medium pharma enterprises to WHO-GMP standards and introduce programmes for the training of professionals in these enterprises. This will result in boosting of exports by Indian pharmaceutical units and consequently, making inroads in the overseas markets. While there is a Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) a l ready in p lace, i t is yet to take off . The government should ensure that the implementation of PTUAS is expedited. Furthermore, greater cooperation in the form of consultancy and training between Indian and overseas regulatory agencies would help existing exporters better understand GMP requirements of such markets as well.

> Health expenditure in India is chiefly financed individually, and this is reflected in the paltry per-capita spending on health in India. Health insurance is thus crucial to the growth of the pharma sector in India. The government should, therefore, introduce

Sanjay SanghviPartner, Khaitan & Co

Suhas SagarAssociate, Khaitan & Co


guest columnmeasures that make heal th insurance affordable for people and reduce reliance on out-of-pocket expenditure, while also promoting schemes such as the Rashtriya Swasthya B ima Yo jna. Th is w i l l have a direct impact on the consumption of pharmaceut ical products, which would otherwise not have been affordable for patients in India.

>The government should implement the earlier announced plan to set up a venture capital fund to provide seed funding for pharma research and development (R&D) to bolster drug inventions and strengthen the pharma infrastructure.

> The government can establish ‘pharma parks’ based on the model adopted for Software Technology Parks with state-of-the-art infrastructure faci l i t ies and a beneficial taxation regime for incentivising t he manu fac tu re o f pha rmaceu t i ca l s in India.

> In order to realise the full potential of the rural markets, the government should work wi th pharma companies through public – private partnership models so as to: improve hygiene and infrastructure conditions, improve primary health centres and improve accessibility of medicines.

Some Tax Measures

> The Ind ian market has so far been dominated by ‘branded generics’ and the pattern seems set to continue unless R&D activities are incentivised in order to make the production of patented drugs more commercial ly viable in a cost-sensit ive market like India. The Indian income tax law currently provides for a weighted tax deduction of 200 per cent on expenses incurred for in-house R&D activities. The government should increase this weighted deduction to 250-300 per cent.

> T h e g o v e r n m e n t s h o u l d c o n s i d e r extending the weighted tax deduct ion on R&D to cove r expenses i ncu r red o n o u t s o u r c i n g t o c l i n i c a l r e s e a r c h organisations (CROs). It can also expand the de f in i t i on o f R&D expend i tu re to include incidental costs, whether incurred in India or overseas (eg, consultancy fees for patents and product registrations in foreign countries). In light of the increasing

use of CROs and the inroads being made by Indian pharmaceutical corporations into the overseas markets, such a measure would be welcomed.

> The government should consider allowing accelerated tax depreciation on capital expenditure incurred in constructing R&D laboratories or manufacturing faci l i t ies that are accredited or approved by reputed international organisations.

> A real game-changing initiative could be to in t roduce a spec ia l In te l lec tua l P roper ty ( IP ) taxa t ion reg ime, under which the income from l icensing of IP developed through R&D in India is taxed at a concessional rate.

This, in addit ion to providing weighted deduction for R&D expenses, would result in Indian companies l icensing their IP around the world and thereby attracting income in Ind ia , wh ich in tu rn wou ld augment overal l tax revenue f rom the pharma sector.

The Union Finance Minister should take his government’s “Make in India” campaign to the next level by taking steps to boost indigenous research. He should give impetus to R&D in the pharmaceutical sector through incentive-linked funding to companies engaged in in-house research and special tax rebates on income from patents, as is the practice in many European countries.

"Government should Give Impetus to Pharmaceutical Export and R&D" – Pawan Chaudhary, Chairman & Managing Director, Venus Remedies

This will help India come up with low-cost innovative solutions in critical care segments like antimicrobial resistance and oncology. The government should take measures to accelerate the pace of growth in the pharmaceutical sector through incentives to exporters, like exemption under Section 80HHC. There is also an urgent need to rectify the inverted structure of excise duty in the pharmaceutical industry.

Temporary tools of taxation like surcharge and education cess should be replaced by a more rational tax structure based on a wider tax base. The government also needs to slash Minimum Alternate Tax (MAT) rates, which are so high that they have started impacting the cash flows of companies. Since many pharmaceutical companies have subsidiaries overseas and are subject to international taxes, safe harbour rules should be extended to cover sales of pharmaceutical products.

“The government should consider extending the weighted tax deduction on R&D to cover expenses incurred on outsourcing to clinical research organisations.”

Considerations when selecting 1.indd 41 20-02-2015 20:38:02


guest column

> The tax holiday, currently granted to an undertaking deriving profits from business of operating and maintaining a hospital located anywhere in India, should be extended from 5 years to 10 years. The government should also consider re-setting the clock on this tax

holiday, so that it starts at the point when the hospital starts making profits, rather than at the date of commissioning and functioning of the hospital. This will result in strengthening of the medical infrastructure in the country, which wi l l prov ide an ind i rect f i l l ip to

the pharma sector by way of increased institutional drug sales.

> The Ind ian pha rmaceu t i ca l sec to r possesses immense potential for growth. However, the government should continue to invest in healthcare and pharmaceutical infrastructure, increase expenditure on healthcare, bolster innovat ion, partner with private companies and incentivise the sector through fiscal measures in order to help the industry achieve new heights. It is a burning desire of the industry that the upcoming budget provides a framework for the execution of such measures by the government.

References

1) Source: Indian Brand Equity Foundation, http://www.ibef.org/industry/pharmaceutical-india.aspx

2) Source: “Indian Pharma 2020 Propell ing Access and Acceptance, Real iz ing True Potential”, a report by McKinsey &Company

3) Section 35(2AB) of the Income Tax Act, 1961


Considerations when selecting 1.indd 42 20-02-2015 20:38:06


marketing initiative

With the new AdCap® product family, Sanner GmbH, a manufacturer of high-quality

plastic packaging for pharmaceutical, medical and healthcare products, offers a 360 degree solution for the highest moisture protection within the package. AdCap® combines the advantages of conventional desiccant capsules and canisters, and ensures optimal moisture adsorption and exceptional stability. AdCap® is easy to handle, universally applicable and complies with global requirements for drug and patient safety.

The new AdCap® product family consists of drop-in desiccant capsules for the protection of moisture-sensitive products. They are best suited for solid pharmaceuticals such as tablets and capsules, as well as food supplements. AdCap® is the consistent further development of the predecessor “360° Capsule” from Sanner. “During our strategic realignment, we placed an even stronger focus on one of our core competencies – the product category Pharma Desiccant Packaging. This already brought forth the new AdPack® desiccant pillow packs. Now we have enhanced the development of our desiccant capsules and established

the AdCap® product family,” explains Sanner CEO Holger Frank.

360 degree moisture protection with unique grid structure

AdCap® is available in three different sizes: apart from the proven one gram version, Sanner now also offers the desiccant capsules with fillings of two and 2.5 grams. The choice of filling materials has also been extended: AdCap® is available with silica gel, molecular sieve and blends. AdCap® combines the advantages of conventional capsules and canisters. The high squeeze stability prevents desiccants from leaking, even under high pressure. At the same time, AdCap® offers effective all-round moisture protection.

The desiccant capsules not only adsorb moisture through a cardboard disc on the top, but also through a unique grid structure on the side of the capsule. even when the capsule is lying on the cardboard side, this ensures moisture adsorption without losing effectiveness after filling within the container – regardless of the capsule’s position inside the package. Moreover, the distinct design of AdCap® offers the

highest patient safety, as its unique grid structure eliminates potential confusion with capsules or tablets, and prevents accidental ingestion. Additionally, the good printing quality increases the readability of the safety instructions.

Cost-efficient product integration

AdCap® desiccant capsules are suited for application all around the world. Because they are dimensioned according to market standards, the capsules are cost-efficient and compatible with standard dispensing equipment and filling lines. AdCap® is delivered in easy-to-handle quantities in aluminum bags. This entails a lower weight and less residue per packaging unit. The desiccants ensure a dust-free application. AdCap® complies with all relevant European and FDA (Food and Drug Administration) regulations for contact with food and drugs. The products are also listed in a Type III Drug Master File (DMF).

AdCap® was presented for the first time at CPhI Worldwide in Paris in October 2014 & in CPhI India in Dec 2014.

Sanner of India

New AdCap® Desiccant Capsules from SannerThe highest patient safety and 360 degree moisture protection for pharmaceuticals and food supplements…

New AdCap.indd 43 20-02-2015 19:23:35

press release


Essel Packaging (Guangzhou) Ltd, Essel Propack’s China arm has been recognized as ’2014 Outstanding Collaboration Supplier ’ by global healthcare company GlaxoSmithKline (GSK) on 27th January 2015 at Tianjin, China.

The maiden certification has been awarded to Essel Propack after GSK’s annual supplier performance evaluation by considering a five-point criterion of – Assurance of supply, Quality, Cost, Service and Innovation. Essel Propack China was rated maximum score in 4 out of 5 of these criteria.

Essel Propack China has a long standing supplier relationship with GSK in China which dates back to 2008, when it started supply to Australia, followed by China in 2011. In 2014, Essel Propack China also started serving GSK in ASEAN markets.This award has been conferred to EPL China for outstanding work delivered for their premium ‘Sensodyne’ brand among all suppliers to GSK across categories.

The company sees huge growth potential in China due to which it inaugurated its fifth plant in the country in Suzhou (East China) for the non-oral care category in December 2014. With this award, EPL is confident of gaining more wallet share from existing clients in oral care, while adding new customers in the non-oral care category.

Essel China Accla imed as Most Preferred Supplier by GSK

India’s leading health care management & research institute, IIHMR Bangalore, signed a Memorandum of Understanding (MoU) with the Netherlands world-renowned Maastricht University’s Faculty of Health, Medicine and Life Sciences (FHML). The scope of activities between the two will focus on innovative student-centred and outcome-based learning methodologies, research as well as exchange of faculty and students. To provide higher education of the highest quality the two partners will apply innovative student-centred and outcome-based learning methodologies. Both parties will share knowledge, experiences and educational research results and to support each other in further educational development. Among other things this mutual support will include curriculum development, the development and application of innovative methodological approaches such as problem-based learning, student assessment, educational quality assurance, programme content development, internationalisation of the curriculum, student support service, and management of education.

IIHMR Bangalore Signs MoU with Maastricht University of Netherlands

Excel Gas & Equipments, India’s leading project management company that operates in the field of gas piping installation for all research laboratories has recently received huge contracts from IOCL, Novartis, GVK Bioscience, Syngenta and Indian Institute of Science Education & Research.

Catering to the requirements of over 15 major industrial sectors and while talking about the pharmaceutical industry in particular, the company has got the opportunities to execute projects of most of the multinational companies as well. In the pharmaceutical industry, the company has executed projects from concept to commissioning for major players like Cipla, Dr.Reddy’s, Biocon, Novartis, Mylan, Pfizer, GVK, Syngenta, Hikal and many more.

Exce l Gas & Equ ipments Wins Contracts from Top Giant Corporations

At PlastIndia 2015, Clariant is highlighting its new ‘REMAFIN-EP’ range of polyethylene (PE) and polypropylene (PP)-based masterbatches. This range of white masterbatches and compounds is targeted for use in production of pharmaceutical containers for parenteral, ocular, and nasal drugs. It complements a range of colors and additives for medical devices and pharmaceutical packaging introduced under Clariant’s MEVOPUR brand.

Sandeep Puri, Head – Masterbatches, Clariant in India said, “Pharma and construction – two significant industries in India, are at the core of Clariant’s innovation pipeline. And now, with Clariant’s broader footprint in India in terms of Masterbatches production, distribution and sales in India, we are fully geared up to support these burgeoning industries.”

Clariant Masterbatches Address Challenges of Indian Pharma Industries

Prantik Mukherjee (née Mukhopadhyay), a young and dynamic industry professional has joined Finar Limited, an Ahmedabad based leading manufacturer of Laboratory and Fine Chemicals as the Director Sales (Lab Business). Prior to joining Finar, Mukhopadhyay was Director - Sales of Merck Millipore Lab Business (a German multinational & a world leader in life sciences). Mukhopadhyay has an industry experience of over 24 years and has held significant portfolios in the Life Sciences Sector (Laboratory Chemicals, Chromatography, Clinical Diagnostics, Specialty Chemicals & Lab Instruments).

Prantik Mukherjee Joins Finar as Director-Sales

Press Release.indd 44 20-02-2015 19:24:33

press release


On 5 February 2015, just days after gaining US Food and Drug Administration (FDA) breakthrough approval for Ibrance (palbociclib) in breast cancer, Pfizer entered into an agreement to purchase generic drug maker Hospira for USD 90 per share in cash, or approximately USD 17 billion, representing about a 40 per cent premium above Hospira’s stock price. The deal comes a number of months after Pfizer ’s failed attempt to acquire AstraZeneca, a move that signaled the company was trying to stem its losses from the patent cliff through inorganic growth means. The purchase of Hospira is expected to be immediately accretive to Pfizer ’s earnings, adding nearly USD 4 billion in sales to Pfizer ’s Global Established Pharmaceutical (GEP) segment sales of almost USD 25 billion. Hospira’s top-line has been relatively flat over the past six years, growing by a Compound Annual Growth Rate (CAGR) of only about 2 per cent. However, the company’s Specialty Injectable Products business, of primary importance to Pfizer, continues to perform well.

While Hospira’s generic specialty injectables product line will be seamlessly integrated into Pfizer ’s GEP business, Hospira’s biosimilar activities are also of key importance to Pfizer ’s strategic objective. Hospira currently markets three biosimilars in Europe – Retacrit (erythropoietin zeta), Nivestim (filgrastim), and Inflectra (infliximab), the first biosimilar monoclonal antibody to be approved in Europe. Meanwhile, Hospira also has a number of biosimilars in its late-stage pipeline, including trastuzumab (Herceptin), currently in Phase III, which is being evaluated for breast cancer. This is hugely complementary to Pfizer ’s own ongoing activities in biosimilar development, with biosimilars of Herceptin, Rituxan and Remicade currently in the pipeline. Although biosimilars have been available in Europe and elsewhere for several years, the US FDA only recently created an approval process for the drugs, which will fuel demand for biosimilars as patents on expensive brand-name biologics expire. Pfizer hopes that by adding Hospira to its portfolio, it will be better positioned to capture a share of the biologics market.

The 3-day BioAsia 2015 concluded amidst many significant agreements and Memorandum of Understandings signed between government and national & international organizations, thought provoking discussions bringing together a large number of industry leaders and government officials (State/Center and international), regulators and academic experts. The last day of the event started with the inauguration of the Healthcare Conferences by Mr. Pradeep Chandra, Special Chief Secretary, Govt of Telangana and Keynote Address was given by Prof. D. Prabhakaran, Vice President, Public Health Foundation of India.

In the course of the day, the jury also selected the best solutions developed during the 1st BioAsia Devthon. Three teams were given grants totaling Rs. 2 lacs for their solutions. All these teams will be working with BioAsia and Technology Business Incubator (BITS Pilani Hyderabad) to develop their prototypes further. TBI will provide them free incubation services for 6 months and monitor progress.

Bosch Packaging Technology, a leading supplier of process and packaging technology, has expanded its portfolio for the serialization of pharmaceutical packaging. In the fight against counterfeit drugs, many countries are about to implement legislation changes for a stricter labelling of pharmaceuticals. Consequently, drug manufacturers require safer and more flexible solutions.

“With our serialization concept, we offer customers more than just a machine,” explains Daniel Sanwald, product manager at Bosch Packaging Technology. “Bosch offers the complete package, which also includes the corresponding IT.” The CPS (Carton Printing System) forms the basis of all serialization solutions from Bosch. It has been continuously developed regarding flexibility and user friendliness. Depending on customer requirements, the system prints 1D or 2D data matrix codes on up to 400 folding cartons per minute. Thanks to an upgrade of the camera system, both codes can now be checked on different carton qualities even more reliably. If the contrast and readability of the data matrix codes do not conform with the required level of quality, the products are automatically sorted out. The machine is easy to operate from the front, so that mechanical components are easily and quickly accessible in case of format changes. An optimized threading of the labelling tape reduces downtime of the CPS 1900 to a minimum.

Pfizer’s Hospira Buyout Lays Foundation for Potential Generics Unit Spin-off

BioAsia 2015 Successfully Concluded

Bosch Expands CPS Portfolio for Pharmaceutical Packaging Serialization

Merck, a leading company for top-quality high-tech products in the pharmaceutical, chemical and life-science sectors, in collaboration with Emirates Diabetes Society (EDS) today announces the start of Merck Capacity Advancement Program (CAP) in Diabetes education for medical, nursing and pharmacy undergraduates and primary healthcare providers so that ultimately they act as Diabetes ambassadors across the UAE.

Merc k , EDS K i c k o f f Capac i t y Advancement Programme


press release


The Diagnostics Division of Siemens Healthcare has unveiled its latest point-of-care acute care analyzer for the management of patients with cardiovascular disease symptoms at Medlab in Arab Health 2015, Dubai, January 26-29. The company’s Stratus CS 200 Acute Care Diagnostic System is designed to enhance simple operation and instrument management at the point of care to help facilitate rapid decision making and optimal patient care.

The new Stratus CS 200 system has a user-friendly, touch screen interface that makes it easy to navigate through menus. A barcode reader eliminates the need for manual entry and reduces potential for error. The system also offers bi-directional connectivity, which allows for safe and secure results transmission with third-party data managers, and provides capability for remote operator lock-out and monitoring of calibration dates. In addition, the Stratus CS 200 system automatically spins whole blood into plasma for testing, reducing the risk of biohazard exposure and ensures results will be comparable to lab tests run on plasma samples.

The Stratus CS 200 system delivers a robust cardiac assay menu, including high-sensitivity Troponin I. First results are available in as fast as 14 minutes, and subsequent results available in as little as four minutes.

Siemens Launches New Point-of-Care Cardiac Analyzer

On 30 January 2015, the Delhi High Court set aside an order dated 13 January 2015 (Order) of the Indian Patent Office (IPO) rejecting a patent to Gilead Pharmasset Inc for a ‘blockbuster ’ Hepatitis C drug ‘Sofosbuvir ’ (brand name: Sovaldi).

The IPO had passed the Order rejecting the patent application based on Section 3(d) of the Patents Act (Act). Section 3(d) of the Act provides that no new form of an existing substance shall be patentable unless there is an enhancement of the known efficacy of that substance.

The Deputy Controller of Patents and Designs (Controller) observed that though modifications described in the patent application made Sovaldi “novel and inventive”, the application filed by Gilead did not prove its enhanced “therapeutic efficacy” compared to its “closest prior art” ie, WO2001/92282.

The patent application for Sovaldi had been opposed by four different entities, (i) Initiative for Medicines, Access & Knowledge (I-MAK) together with the Delhi Network of Positive People, (ii)

Delhi High Court Sets Aside IPO Order on Gilead’s Patent Application

Nigel Theobald, founder and CEO, N4 Pharma has announced the launch of two advanced technologies to expedite and enable reformulation of poorly soluble drugs and to improve the effectiveness of existing vaccines.

Based in Chellaston, Derbyshire, the N4Pharma proprietary technology platforms offer the potential for rapid, high multiple returns by reducing the associated risk, time and cost of developing new products for the pharmaceutical market.

Approximately 40 per cent of existing drugs and over 90% of new drugs have problems with solubility, often resulting in poor absorption rates of these drugs into the body. Cocrys, the N4 Pharma patented drug solubility process, significantly improves and advances the solubility of a wide range of drugs.

Furthermore, Cocrys is a commercially viable process for pharmaceutical companies as it is the only process that allows for the large scale manufacture of co-crystals using hot melt extrusion.

The second technology, Nuvac is an innovative vaccine delivery system that loads the vaccine antigen into a nano-carrier which improves the ability of the vaccine to kill virus cells, increase antibody production and reduce the number of doses required. Often effective vaccine protection requires numerous doses and this can lead to major issues implementing vaccine programs.

Through Nuvac N4Pharma is directly addressing a global public health priority for a new type of vaccine technology, something especially important for developing countries.

N4 Pharma Introduces Breakthrough Pharmaceutical Technologies

Natco Pharma, (iii) BDR Pharmaceuticals and recently, (iv) Sankalp Rehabilitation Trust.

According to the Act, the IPO was required to notify Gilead about the pregrant oppositions filed against their patent application, which it seems, they had failed to do. Thus, according to sources, procedural irregularity had taken place at the pre-grant opposition stage and therefore, the Delhi High Court had remanded the patent application back to the IPO. The Controller contended that he had not relied on claims made in the pre-grant opposition before passing the Order.

A written order has not yet been issued by the Delhi High Court. Further details/clarifications may emerge once the Order is made available.


press release


In the first fiscal year since joining the Romaco Group, Kilian Tableting GmbH’s order volume has gone up fifteen percent. As a result of acquiring Kilian, Romaco is now optimally placed to offer tableting and packaging solutions from a single source.

The incorporation of Kilian Tableting GmbH, based in Cologne, Germany, into the Romaco Group has been an outstanding economic success – this is the excellent news at the end of the first joint fiscal year. Driven by a fifteen percent rise in the order volume, Romaco Kilian has easily exceeded the original targets.

The united expertise of the Kilian, Siebler and Promatic product lines has helped the Romaco Group create groundbreaking synergetic effects that enable a direct connection between tablet presses and primary, secondary and final packaging solutions. Last year several contracts for integrated strip packaging lines were signed with customers in the U.S. and China. Romaco has achieved its stated objective of breaking into new pharmaceutical and healthcare markets following the formal takeover of Kilian Tableting GmbH with all-in-one solutions for tableting and packing pharmaceutical solids.

Kilian Gets off to a Successful Start in the Romaco Group

TAKE Solutions Ltd., a global business technology solutions provider, today announced the launch of the TAKE Academy of Life Science and Leadership (TALL) to cater to the talent needs of the Life Sciences industry. This is with an aim to create a well-informed and industry-ready workforce that is competent in an era of transparency, collaboration, continuously transforming regulatory standards, and for enabling better healthcare for the global patient population.

The Life Sciences industry is a knowledge industry that requires deep domain expertise, knowledge of emerging regulations, and strict enforcement of quality and compliance. The pace of change driven by increased automation leveraging cutting edge technology solutions and mandates by global regulatory agencies for safer and more effective drugs at affordable healthcare costs is extremely high. The training needs of the existing and new workforce have to be addressed and TALL delivers a differentiated curriculum to address this agenda.

With the overarching objective of addressing the skill and knowledge gap in the life sciences industry, the TAKE Academy of Life Science and Leadership works to enhance the proficiency of the existing workforce, enables technical

TAKE Launches ‘TALL’

expertise of students and reaches out to underprivileged youth to take up higher education through its “Earn while you learn” scheme. TALL’s hands-on approach to delivering industry-oriented curriculum along with providing candidates with the best of wet lab facilit ies as well as access to technology solutions via computer labs for real and practical experience to solving industry challenges is very unique. The academy has adopted innovative teaching methodologies in physical and virtual classrooms, to impart skills as well as self-empowerment through leadership training.

B&R Innovation Day 2015

B&R Automation is always recognized for its trend setting automation solutions. Innovation Day 2015 organized by B&R India on 9th January 2015 in Hotel Hyatt Regency, Pune served an ideal platform for deliberating on innovations for manufacturing industry.

B&R Innovation Day 2015 was attended by over 120 delegates from various industries encompassing end users, OEMs and integrators. B&R presented the innovations for 2015. There were eight presentations made by B&R experts.

P V Sivaram, Managing Director, B&R India spoke about “B&R Innovations to add Value” highlighting how technology can help us to benefit from the opportunities in the form of Industry 4.0 and Make in India initiatives. Other interesting presentations included topics like mapp Technology for modular application development, Plant Automation, Ultrafast Automation, Modular Industrial PCs, Extreme Ruggedness, Scalability+ and Redundancy. These presentations were supported by live demonstrations on all-in-one software platform - Automation Studio, plant and factory automation, new HMIs, multi-touch panels and Automations PCs, motions technology, and real time industrial Ethernet - POWERLINK.

Prominent guest speakers added value by shedding light on industry trends, overall plant efficiency and much more. A key note was delivered by chief guest Shirish Divgi, Managing Director, Ferromatik Milacron India. His presentation focused on customer expectations which act as fuel to innovations.

M Ramesh Babu, National Head – Projects, Hindustan Coca-Cola Beverages, delivered an informative speech on “Planning for future plant expansions – Scalability of automation – Trends vs Reality”. An engaging presentation on “Increasing importance of software in machine building” was given by Nikhil Baste, Founder Director, Technoshell Automations which highlighted how superior software is instrumental in better solutions.



pharma news

Lupin, Celon Ink Deal for Generic Advair Diskus

Pharma Major Lupin Limited, an innovation led transnational pharmaceutical company producing and developing a wide range of branded and generic formulations, and Celon Pharma SA have entered into a definitive agreement under which the companies will jointly develop fluticasone/salmeterol dry powder inhaler (DPI) product which is a generic version of GlaxoSmithKline’s Advair Diskus.

Lupin will be responsible for commercialization of the product. Celon will supply the product to Lupin for its commercialization in the United States, Canada, Mexico, and other key markets. GlaxoSmithKline’s Advair Diskus had global sales of over USD 7 billion as of last fiscal.

Lupin CEO Vinita Gupta said, “This collaboration is an important milestone in Lupin’s efforts to evolve its global inhalation pipeline. We are very pleased to partner with Celon given their experience in the development and manufacturing of fluticasone/salmeterol DPI in Europe. This coupled with Lupin’s expertise in inhalation product development and commercialization in the US and other markets will accelerate the development of generic Advair Diskus for global markets. We look forward to providing access to high quality, affordable fluticasone/salmeterol DPI as part of our strategy to deliver inhaled products to key markets.’

Actavis may Change Name to Allergan

Actavis plc has announced that it will adopt a new corporate name – Allergan – following the anticipated successful completion of the acquisition of Allergan, Inc. The Company said that it intends to use the Allergan name as its corporate name and for its global branded pharmaceutical portfolio, and will retain the Actavis name for select geographic regions and product portfolios.

The change in corporate name would be subject to approval by Actavis’ shareholders at its Annual General Meeting later this year.

Actavis will ask shareholders to approve its intention to adopt the Allergan name at its Annual General Meeting of Shareholders later this year. Pending shareholder approval, and formal adoption of the new corporate naming structure, Actavis will continue to operate under its current name and trade on the New York Stock Exchange under its present symbol – ACT.

Norgine’s Targaxan 550 Gets NICE Approval

Targaxan 550 (rifaximin-α 550mg), an innovative treatment for hepatic encephalopathy (HE), will be available to patients in England and Wales following its approval by the National Institute for Health and Care Excellence (NICE).

Hepatic encephalopathy is a serious and potentially life-threatening neuropsychiatric condition associated with advanced liver disease that affects around 10,000 patients in the UK. Norgine markets this innovative treatment which is licensed for the reduction in recurrence of episodes of overt hepatic encephalopathy in patients of 18 years of age and over. Peter Martin, Chief Operating Officer, Norgine said, “Norgine is very pleased that the true value of Targaxan 550 has been recognised. It is a reflection of the value this medicine brings to patients, carers and the healthcare system, as demonstrated in the real world data that was submitted. It is critical to have additional treatment options for hepatic encephalopathy as liver disease is increasing and there is currently no cure for HE apart from liver transplantation.”

Sanofi, Lead Pharma to Develop Therapy for Autoimmune Diseases

Sanofi has entered into a research collaboration and license agreement with Dutch biotech Lead Pharma to discover, develop and commercialize small-molecule therapies directed against the nuclear hormone receptors called ROR gamma t to treat a broad range of autoimmune disorders, including rheumatoid arthritis, psoriasis and inflammatory bowel disease, which are among the most common.

Under the terms of the agreement, Sanofi and Lead Pharma will collaborate during the early phase of research and development with a goal of identifying drug candidates and beginning human trials within 3-4 years. Lead Pharma will receive an upfront payment and is eligible to receive research, development, regulatory and commercial milestone payments.

Sanofi will be responsible for clinical development and have worldwide marketing and commercialization rights to any products that may be developed as a result of the collaboration. Lead Pharma is entitled to receive royalty payments on global sales from any such products. Further details of the financial terms have not been disclosed.

Recent findings that show the biological function of ROR gamma (t) can be moderated with small molecules have propelled this target to the cutting edge of drug discovery.

Pharma news.indd 48 20-02-2015 19:25:56


pharma news

Kinex Licenses Patents from Two Universities Kinex Pharmaceuticals has announced the exclusive licensing of global rights of three patents from The Hong Kong Polytechnic University and McGill University. These three patents covered the inventions by Professor Larry Chow and Professor William Chan including novel new chemical compounds that have nanomolar potency against a molecular target named Breast Cancer Resistance Protein (BCRP). BCRP is a protein pump known to pump drugs, including anticancer drugs, from cancer cells that can lead to drug resistance; and also to pump drugs back into gastrointestinal tract, which prevent some useful drugs to be delivered to their target. The development of this technology, if successful, will expand the current Kinex oral drug absorption development platform. That platform currently includes the inhibition of P-glycoprotein that Kinex licensed from Hanmi in 2011. The lead molecule, HM30181A, has been shown in clinical studies to enhance the absorption of anticancer drugs including paclitaxel and irinotecan into orally available drugs. The lead program, Oraxol (an oral form of paclitaxel), has demonstrated clinical efficacy and an excellent safety profile in patient studies.

Japan Approves Teijin’s Mucosolvan L TabletTeijin Pharma Limited, the core company of the Teijin Group’s medical and pharmaceutical business, has announced that Japan’s Ministry of Health, Labour and Welfare approved Teijin Pharma’s novel expectorant drug formulated as a reduced-size tablet, Mucosolvan L tablet 45 mg (ambroxol hydrochloride), on February 16. Teijin Pharma plans to launch the tablet this summer.

This sustained-release tablet measures just 7.5 mm x 6 mm, which is smaller and more easily swallowed than conventional once-daily expectorant drugs. It contains the same active ingredient as Mucosolvan L capsule 45mg, a once-daily product now on the market, and expected to have the same effect, especially when administered after dinner for the treatment of productive sputum the following morning.

The medical field has high expectations for the tablet’s reduced size, as expectorants are often taken with other drugs. The tablet is also expected to be effective for treating productive sputum in the morning.

Teva Launches Generic Lovenox & Zyvox

Teva Pharmaceutical Industries Ltd, a leading global pharmaceutical company, has announced the launch of the generic equivalent of Lovenox (enoxaparin sodium injection) in seven dosage strengths in the United States. Enoxaparin Sodium Injection, USP is used for prophylaxis of deep vein thrombosis (DVT) in patients undergoing abdominal surgery, hip or knee replacement surgery, or in medical patients with severely restricted mobility during acute il lness; and also for the treatment of acute DVT. Lovenox had annual sales of approximately USD 1.8 bill ion in the United States, according to IMS data as of November 2014.

Under a licensing agreement, Teva has partnered with Chemi SPA to leverage their internal research based technology in the development and manufacture of Enoxaparin Sodium Injection, USP.

Teva has also recently launched the generic equivalent to Zyvox (linezolid) Injection which is used for the treatment of infections caused by Gram-positive bacteria. Zyvox Injection had annual sales of approximately USD 464 million in the United States, according to IMS data as of October 2014.

US FDA Grants Orphan Drug Status to Bexion’s Saposin C

Bexion Pharmaceuticals LLC announced that the US Food and Drug Administration (FDA) has granted the company Orphan Drug designation for Saposin C, active ingredient in its proprietary drug BXQ-350 for the potential treatment of glioblastoma multiforme.

The FDA’s Office of Orphan Drug Products Development reviews applications for Orphan Drug status to support development of medicines for underserved patient populations, or rare disorders that affect fewer than 200,000 people in the United States. The successful application submitted by Bexion and the FDA granting of Orphan Drug status entitles the company to a seven-year period of marketing exclusivity in the United States for BXQ-350, if it is approved by the FDA for the treatment of glioblastoma multiforme. Orphan Drug status also enables the company to apply for research grant funding for Phase I and II Clinical Trials, tax credits for certain research expenses, and a waiver from the FDA’s application user fee, as well as additional support from FDA and a potentially faster regulatory process.

Bexion was previously awarded a prestigious Phase II Bridge Award (Small Business Innovation Research Grant; SBIR) from the National Cancer Institute (NCI) to support the manufacture and clinical testing of BXQ-350.

Pharma news.indd 49 20-02-2015 19:26:13


pharma news

Trimel Files NDA with Health Canada for NATESTOTrimel Pharmaceuticals Corporation has filed a New Drug Submission with Health Canada for NATESTO (testosterone) nasal gel for replacement therapy in men for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism).

“The fil ing of NATESTO with Health Canada represents another significant milestone for Trimel and the many patients this therapy aims to address,” said Tom Rossi, President and CEO of Trimel. “We believe that NATESTO meets an important unmet medical need for men suffering from ‘Low T’ and, if approved, we look forward to bringing this treatment to market in Canada.”

NATESTO is the first testosterone nasal gel fi led in Canada for approval, and is the first and only approved testosterone nasal gel in the United States for replacement therapy in adult males diagnosed with hypogonadism. The commercial rights to NATESTO in the United States and Mexico have been licensed by Trimel to an affil iate of Endo International plc. Endo intends to launch the product in the US, through its Endo Pharmaceuticals subsidiary, in this first quarter of 2015.

Sun Pharma’s Ranbaxy Acquisition Gets US FTC Clearance

Sun Pharmaceutical Industries Ltd and Ranbaxy Laboratories Ltd have announced that the US Federal Trade Commission (FTC) has completed its review of the proposed acquisition of Ranbaxy by Sun Pharma and has granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act).

The early termination of the waiting period under the HSR Act satisfies one of the essential conditions to the closing of the Ranbaxy acquisition.

Sun Pharma and Ranbaxy also announced that the FTC accepted a proposed consent agreement pursuant to which, Sun Pharma and Ranbaxy have agreed to divest Ranbaxy’s interests in generic minocycline tablets and capsules to an external third party.

Sun Pharma and Ranbaxy are working closely towards completion of the transaction and will comply with the conditions laid down in the FTC consent agreement within the specified time.

Zydus Cadila Completes SAD Phase I Studies for ZYAN1Zydus Cadila has completed the single ascending dose (SAD) range finding studies of ZYAN1 in healthy human volunteers as a part of the Phase I study currently ongoing in Australia. The molecule, ZYAN1 is an orally bioavailable hypoxia-inducible factorprolyl hydroxylase (HIF-PH) inhibitor being developed for the treatment of anemia. ZYAN1 has been designed to increase the natural production of erythropoietin (EPO) in anemic patients.

Anemia is a condition of having lower red blood cells or lower hemoglobin levels than is normal. Anemia is a serious medical condition linked to increased morbidity and mortality, and is commonly observed in patients with chronic kidney disease (CKD). Currently available agents for the treatment of anemia include injectable EPO stimulating agents (ESA’s) and intravenous iron supplements. The estimated global market for treatments for anemia related to CKD is USD 10 bill ion.

US FDA Accepts Pfizer’s ALO-02 NDA

Pfizer Inc has announced that the US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride), extended-release capsules, an abuse-deterrent formulation (ADF) opioid for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. ALO-02 is an extended-release oxycodone specifically designed to reduce abuse via the oral, intranasal (ie, snorting) and intravenous (IV) routes when crushed.

Prescription opioids are an important treatment option for patients with chronic pain, but the misuse, abuse, and diversion of these agents remains a serious and persistent problem. In 2013, according to the National Survey on Drug Use and Health, nearly 10 million US adults reported prescription pain reliever use for non-medical purposes in the previous year. Abuse deterrent opioid medications incorporate technology designed to make the product difficult to abuse, yet when used appropriately, provide patients with intended pain relief.

Pfizer believes that abuse deterrent formulation opioids, including ALO-02, are an important step toward helping to address the growing public health issue of opioid abuse in the US. Pfizer supports the appropriate use of opioid pain medications and is committed to research in this field. If approved, ALO-02 would become Pfizer ’s second abuse deterrent formulation opioid.

Pharma news.indd 50 20-02-2015 19:26:14

Pharma Bio World February2015 51

biotech news

Agilvax Inc has announced a collaboration with Switzerland based Humabs BioMed that will contribute to the rapid advancement of Agilvax’s ever expanding vaccine and immunotherapy pipeline. Humabs BioMed has established itself as an innovator and leader in the development of human monoclonal antibodies. Agilvax is excited to utilize antibodies developed from patient survivors of infectious and chronic diseases. The use of these therapeutic antibodies, which have been proven to be efficacious both in vitro and in in vivo, represent the ideal antibody source to identify virus-like-particle (VLP) vaccine candidates and immunotherapies using Agilvax’s innovative affinity selection technology. Affinity selection with Humabs’ antibodies will lead to the production of VLPs that induce high-titer, durable, and protective antibody responses that mimic the selecting therapeutic monoclonal antibody. Utilization of Humabs’ best-in-class antibodies will promote the successful development and commercial launch of vaccines and immunotherapies to combat diseases with unmet medical needs.

Lonza, TiGenix Sign Deal to Develop Stem Cell-based TreatmentLonza, a global leader in biological and cell therapy manufacturing and TiGenix, an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from allogeneic expanded adipose-derived stem cells (eASCs) in inflammatory and autoimmune diseases, have announced an agreement for the supply of TiGenix’s eASC product, Cx601. Under the agreement, Lonza will manufacture material for the Phase 3 trial of Cx601 in the US at Lonza’s cell therapy production facility in Walkersville, Maryland (US).

Cx601 is a locally-injected suspension of allogeneic expanded adipose-derived stem cells (eASCs) for the treatment of complex perianal fistulas in Crohn’s disease patients, currently in Phase 3 of clinical development in Europe. Following the positive feedback received at a meeting with the Center for Biologics Evaluation and Research within the US Food and Drug Administration (FDA), TiGenix is moving ahead with the development of Cx601 for the US market. To supply Cx601 for a Phase 3 trial in the US, and potentially for the US market when the product has been fully approved, TiGenix has chosen to partner with Lonza as its contract manufacturing organization (CMO). TiGenix will begin the process of technology transfer to Lonza in the coming weeks.

Certara, the global biosimulation technology-enabled drug development and drug safety consulting company, has announced that it will be launching version 8.0 of its D360 R&D “big data” platform for the biopharmaceutical industry at the 22nd International Molecular Medicine Tri-Conference to be held February 15-20 at the Moscone North Convention Center in San Francisco. Certara’s D360 R&D data platform solves big data challenges faced by scientists and IT staff throughout biopharmaceutical organizations by integrating and leveraging the large amount of diverse scientific data generated by sponsor companies and their outsourced partners to optimize crucial R&D decisions.

D360 provides scientific data integration, access, analysis, and visualization capabilities for early discovery through to the preclinical and clinical phases of drug development. D360 solves both intra and inter-domain research challenges by integrating data from multiple source systems to provide standard data views and data mining capabilities. In addition, D360 brings context and understanding to the data, enabling scientists to gain deeper insight and make better scientific decisions.

Certara Launches Version 8.0 of D360 R&D ‘Big Data’ Platform

Agilvax, Humabs BioMed to Develop Targeted Vaccines and Immunotherapies

Theravance Begins Patient Registry Study for VIBATIV(R)

Theravance Biopharma, Inc has announced enrollment of the first patient in the Company’s Telavancin Observational Use Registry (TOUR). The study is designed to assess how VIBATIV (telavancin), the Company’s proprietary FDA-approved antibiotic, is being used by healthcare practitioners to treat patients. By broadly collecting and examining real-world data related to VIBATIV treatment patterns, clinical effectiveness and safety outcomes in medical practice, the Company aims to create an expansive knowledge base to guide optimal clinical use and future development of the drug.

VIBATIV is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with in vitro potency and a dual mechanism of action whereby telavancin both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function. The drug’s proven efficacy against difficult-to-treat infections has been demonstrated in several large, multinational registrational studies, which involved one of the largest cohorts of patients with methicillin-resistant Staphylococcus aureus (MRSA) infections studied to date. Recently presented study analyses further supplement the extensive and well-documented evidence of the drug’s in vitro potency and in vitro activity against a broad collection of bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant.

Biotech news.indd 51 20-02-2015 19:26:57


biotech news

Synageva BioPharma Corp, a biopharmaceutical company developing therapeutic products for rare disorders, announced that the European Patent Office issued European Patent No. EP2613798 B1 relating to the treatment of lysosomal acid lipase deficiency (LAL Deficiency). This patent provides protection until 2031, not including any patent term extension.

In March 2014, the U.S. Patent and Trademark Office issued U.S. Patent No. 8,663,631 relating to methods of treating LAL Deficiency. The US patent also provides protection until 2031, not including any patent term extension. These patents complement existing and planned global patent portfolios covering the company’s LAL Deficiency program, which includes intellectual property directed to compositions of matter, methods of use and manufacturing.

Kanuma is a recombinant form of the natural, human LAL enzyme being developed by Synageva as an enzyme replacement therapy for LAL Deficiency. Kanuma has been granted orphan designation by the US FDA, the European Medicines Agency (EMA), and the Japanese Ministry of Health, Labour and Welfare. Additionally, Kanuma received fast track designation by the FDA, and Breakthrough Therapy designation by the FDA for LAL Deficiency presenting in infants.

Synageva Receives European Patent for Treatment of LAL Deficiency

Researchers have identified a new gene that is associated with sporadic Amyotrophic Lateral Sclerosis (ALS), or Lou Gehrig’s disease by using advanced DNA sequencing methods. ALS is a devastating neurodegenerative disorder that results in the loss of all voluntary movement and is fatal in the majority of cases. The next-generation genetic sequencing of the exomes (protein-coding portions) of 2,874 ALS patients and 6,405 controls represents the largest number of ALS patients to have been sequenced in a single study to date. Though much is known about the genetic underpinnings of familial ALS, only a handful of genes have been definitively linked to sporadic ALS, which accounts for about 90 per cent of all ALS cases. The newly associated gene, called TBK1, plays a key role at the intersection of two essential cellular pathways: inflammation (a reaction to injury or infection) and autophagy (a cellular process involved in the removal of damaged cellular components). The study was conducted by an international ALS consortium that includes scientists and clinicians from Columbia University Medical Center (CUMC), Biogen Idec, and HudsonAlpha Institute for Biotechnology.

New ALS Gene Identified

Janssen Research & Development, LLC (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has launched three new research platforms focused on disease prevention, disease interception, and the microbiome – areas of transformational medical innovation that are expected to change the healthcare landscape.

The new teams will collaborate closely with Janssen’s five Therapeutic Areas as well as external partners to underpin ongoing research and propel scientific knowledge in these areas of significant potential to change the way diseases are managed.

“The future of healthcare will increasingly depend on identifying and correctly interpreting the earliest signals of disease susceptibility, preventing or intercepting disease before it even begins, and using the latest scientific insights from promising, emerging fields like the microbiome, to transform medicine,” said William Hait, MD, PhD, Global Head, Janssen Research & Development.

Janssen Launches Research Platforms to Focus on Disease Prevention

GSK has acquired GlycoVaxyn AG, a specialist vaccine biopharmaceutical company based in Switzerland. Since forming a scientific collaboration in 2012, GSK has held a minority stake in GlycoVaxyn and has now acquired the remaining shares for USD 190 million in cash to take full ownership of the company.

GlycoVaxyn has developed an innovative biological conjugation platform technology which has the potential to play an important role in the development of new prophylactic and therapeutic vaccines for a range of bacterial diseases. This proprietary technology also has the potential to enable GSK to develop a simplified conjugate vaccine manufacturing process.

Under the terms of the transaction, GSK will additionally acquire a small number of early stage vaccines in development against bacterial infections such as pneumonia, Pseudomonas,Staphylococcus aureus and Shigellosis, supplementing the company’s existing vaccines pipeline.

GSK and the GlycoVaxyn management team are committed to an innovative collaboration and will work together over the next few months to develop ways of working that will maintain the autonomy and agility of GlycoVaxyn whilst delivering the scale and support that GSK can provide.

GSK Acquires GlycoVaxyn


Pharma Bio World February2015 53

biotech news

Provectus Biopharmaceuticals, Inc, a development-stage oncology and dermatology biopharmaceutical company, has held a Type C meeting with the US Food and Drug Administration to review certain operational aspects of the protocol for its planned phase 3 clinical trial of intralesional PV-10, its novel investigational drug for cancer, as a treatment for melanoma. The meeting was held by teleconference on January 29, 2015.

Eric Wachter, PhD, CTO of Provectus, stated, “As noted in our press release of December 22, 2014, when we submitted the protocol to the Agency in November 2014, we included a brief list of questions about certain operational aspects of the protocol. The FDA subsequently indicated that a formal meeting was appropriate to assure that these questions were addressed in a timely and comprehensive manner. As is typical for such meetings, we provided a more extensive list of questions in the formal meeting package. This led to a very thorough and helpful review of the protocol as a result of the meeting.”

Topics formally reviewed included subject eligibility requirements, primary and secondary study end points, and study lesion definitions and conventions for defining disease progression.

Provectus Discusses Operational Aspects of PV-10 Phase 3 Study

Marina Biotech, Inc, a leading nucleic acid-based drug discovery and development company focused on rare diseases, and MiNA Therapeutics Limited, the pioneer in RNA activation therapeutics, announced today that they have entered into a license agreement regarding the development and commercialization of small activating RNA (saRNA) based therapeutics utilizing MiNA’s proprietary oligonucleotides and Marina’s novel SMARTICLES nucleic acid delivery technology. MiNA will have full responsibility for the development and commercialization of any products arising under the Agreement and Marina Biotech will support preclinicaland process development efforts. Under terms of the Agreement, Marina Biotech could receive up to USD 50 million in total upfront, clinical and commercialization milestone payments, as well as royalties on sales, based on the successful outcome of the collaboration. Further terms of the Agreement were not disclosed.

Clinical achievements with SMARTICLES represent the combined experiences (a total of approximately 100 patients) of licensees ProNAi Therapeutics, Inc, Plymouth, MI and Mirna Therapeutics, Inc., Austin,TX.

Marina, MiNA to Develop saRNA-based Drugs

Galena Biopharma, Inc, a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major medical needs across the full spectrum of cancer care, has announced that its partner, Orexo AB, has filed a patent infringement lawsuit in United States District Court for the District of New Jersey, against Actavis Laboratories FL, Inc, Andrx Corporation, Actavis, Inc and Actavis Pharma, Inc.

The lawsuit was filed in response to the Abbreviated New Drug Application filed by Actavis. In its application, Actavis seeks to market and sell generic versions of Abstral (fentanyl) sublingual tablets in the U.S. prior to the expiration of Orexo’s U.S. patents for Abstral listed in the FDA’s Orange Book. The listed patents are US patents 6,759,059, 6,761,910 and 7,910,132 with expiration dates in September 2019. Galena currently markets Abstral and is the owner of the New Drug Application in the United States.

Because Orexo initiated a lawsuit against Actavis in a timely manner, the FDA is statutorily precluded from approving Actavis’ ANDA for 30 months, or until a district court decision finding the patents invalid or not infringed, whichever occurs earlier. The 30-month stay period began as of the date Orexo received the Notice Letter from Actavis that notified Orexo of the ANDA filing.

Orexo AB Sues Actavis for Patent Infringement

Alimera Get Nod to Market ILUVIEN in Finland & Luxembourg

Alimera Sciences, Inc, a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, has announced that marketing authorization has been granted by the Finnish Medicines Agency in Finland and the Ministry of Health in Luxembourg to ILUVIEN for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.

Approvals in Finland and Luxembourg mark the 14th and 15th European approvals through the Repeat-Use application procedure. ILUVIEN is now approved for marketing in Austria, Belgium, Denmark, France, Germany, Ireland, Italy, the Netherlands, Norway, Portugal, Spain, Sweden, the United Kingdom and the United States, and is commercially available in the United Kingdom, Germany and Portugal. Alimera expects to begin commercializing ILUVIEN in the U.S. in February 2015. ILUVIEN is pending approval in the Czech Republic and Poland, the two remaining countries in the European Union (EU) included in the Repeat-Use application procedure.



Avacta Analytical has extended the versatility of the Optim 2 protein stability and characterisation instruments, with a version featuring an additional 375 nm laser that significantly enhances the measurement of stability information for membrane proteins. The Optim 375 can be used to effectively guide purification and biophysical characterisation efforts, including crystallisation, by tracking the exposure of cysteine residues within the protein interior as an indicator of protein unfolding, with the ability to simultaneously follow protein aggregation using the

system’s built-in static light scattering. Developed to reduce the time and cost of therapeutic protein pre-formulation studies, the Optim family of analysers are utilised in applications such as lead candidate selection and optimisation, candidate formulation and stability studies. The speed and cost advantages that these instruments deliver are due to the tiny sample volumes required (9 microlitres), and the ability to undertake parallel measurements of up to 48 samples in just a few hours.

For more information, please contact:Avacta AnalyticalUnit 706 Avenue E West, Thorp Arch EstateWetherby LS23 7GA, U.K.Tel: +44 (0)844 414 0452, +44 1904 217072 | Fax: +44 (0) 844 414 0453E-mail: [email protected]

Analyser for Membrane Protein Stability Tests

eVoI brings the technological advancements of laboratory liquid dispensing up to the levels seen elsewhere in the lab.

eVol is a complete dispensing solution with a broad range of functions and uses. eVol revolutionises the way laboratories work and the pace at which they process samples.

eVol is the coupling of two precision devices: a digitally controlled electronic drive and an XCHANGE (Patent Pending) enabled analytical

syringe. The result is a digitally controlled positive displacement dispensing system that can be programmed to reproducibly and accurately perform a wide variety of liquid handling procedures.

For more information, please contact:Kinesis India Pvt LtdANM House, Plot No: A-141Road No: 2, Wagle Indl Area, Thane (W), Maharashtra 400 604Tel: 022-66141668 | Fax: 91-022-66681600E-mail: [email protected]

Digitally Controlled Analytical Syringe

Inkarp Instruments Pvt Ltd offers laboratory freeze dryer for acids and organic solvents. Solvent of most samples is water, whereas some solvents contain acid, alkaline or organic substance, for example: acetonitrile, solvent of protein, alcohol solution, folic acid solution, TFA, weak alkaline solution, etc. These substances cannot condense to solid in

cold trap of -50oC effectively and they may corrode vacuum hose, organic valve, oil-sealed vacuum pump cavity and sealing ring because of their acidity and alkalinity. If your sample contains acid or organic substance and you do not take measures to protect your vacuum pump, it would leak after some time until it is beyond repair. Inkarp Instruments Pvt Ltd strongly suggest an A-Assembly accessory to your freeze dryer for acid and organic application, for example. Inkarp Instruments select A-Assembly component for FD8-3, PiloFD8-5.3 to form FD8-3a, PiloFD8-5.3a.

For more information, please contact:Inkarp Instruments Pvt Ltd1-2-45/1, Street No: 2, Kakateeya Nagar ColonyHabsiguda, Hyderabad, Andhra Pradesh 500 007Tel: 040-27172293, 27175088 | Fax: 91-040-27154686E-mail: [email protected] / [email protected]

Laboratory Freeze Dryer

Product.indd 54 20-02-2015 19:27:58


Shefa Industries offers high quality octagonal blender, which is a versatile blending machine, highly durable and provide better usage. This range of products is tested on different quality standards and

is used for mixing and fabrication process of dry granules homogeneously. These blenders are offered in different specifications, sizes, shapes and provide effective results for granules because of slow speed and octagonal shape of the container. These are used in pharma, food, chemical and cosmetic products, etc.

Brill iant Process Machinery Pvt Ltd offers zero filter press, reverse flow zero hold up type.

Here the direction of flow of liquid is exactly opposite to the flow in standard filter, ie, the impure

liquid to be filtered enters the filter from the bottom into the centre channel and goes to the top of each plate.

The clear filtrate flows out from openings on side of plates to the shell and then to the outlet. This flow ensures almost 100 per cent fi ltration of the liquid.

For more information, please contact:Shefa IndustriesGala No: 1, U K Quari CompoundGandhi Nagar, Vikhroli (W), Mumbai 400 083Tel: 022-25942473E-mail: [email protected]

For more information, please contact:Brilliant Process Machinery Pvt LtdUnit No: 1, 2 and 14, Modern Indl Estate Opp: IPOLWaliv hata Vasai (E), Dist: Palghar, Maharashtra 401 208Tel: 0250-3293636, 2454015 | Fax: 91-0250-2454015E-mail: [email protected]

Octagonal Blender Zero Filter Press

The PT-DT70 is fully compliant to all major pharmacopoeias, like USP 717, EP 2.9.3 as well as the Japanese Pharmacopoeia. It is a low-head dissolution tester, which provides a space saving low cost entry into tablet dissolution testing. It offers seven stirred positions as well as a pneumatically supported lift-off top for easy access to the dissolution vessels.

The vessels are arranged in two rows (4+3) and are easily accessible to remove spent media and refil l with solvent, simply by lifting up the pneumatically assisted drive housing. To insert samples and withdraw sample solutions, use the seven tube shafts

which run through the top cover of the instrument.

Simply place your tablets next to the holes and introduce them when ready to start. For easy sampling use the PT-MDS manual sampling system, which includes a SS sampling tube, an in-line filter and a 10-ml disposable syringe. The PT-DT70 is already equipped with all necessary interfaces for easy integration into automated systems.

For more information, please contact:Pharma Test Instruments India Pvt LtdNo: 2 Sree Datri Niwas, 2nd Floor, Nagwara CircleOuter Ring Road, Opp: Manyata Softech ParkBengaluru, Karnataka 560 045E-mail: [email protected]

Compact Dissolution Testing Instrument

Product.indd 55 20-02-2015 19:28:14


New range of refrigerators from REMI is designed for storage applications in pharma, microbiology, biotechnology, chemical, clinical diagnostic, hospitals and research institutions.

The unit is supplied with a glass door for

convenient sample viewing, forced air circulation system ensures uniform temperature throughout the chambers.

Digital controller is provided for display of internal temperature along with alarm systems.

PAC 150 is three arm rotary pick-up version of cartoner with an output of 150 upm.

The machine is available with leaflet insertion option; pick and place type machine integration and servo motor based machine with 200 upm output.

Due to robust design and good manufacturing practice, the machine delivers the best packaging quality standard and with minimal maintenance intervention, the operating efficiency is also very high.

For more information, please contact:REMI Sales & Engg LtdRemi House, 11 Cama Indl Estate, Walbhat RoadGoregaon (E), Mumbai 400 063Tel; 022-40589888, 26851998 | Fax: 91-022-40589890E-mail: [email protected]

For more information, please contact:PacMac Solution Pvt LtdA-101 to 109, Dadra Indl EstateOpp: Dadra Check PostSilvassa, Dadra & Nagar Haveli 396 193E-mail: [email protected]

Laboratory Refrigerators Cartoner Machine

The APPIDI dehumidifiers are based on the desiccant dehumidifying technology. It uses a solid-desiccant rotor, consisting of stabilised silica gel bonded to a high resistant substrate that is slowly rotated. As the air passes through the fluted rotor, it adsorbs moisture from the process air that is dictated to the unit and is blown through an approx 70 per cent of the rotor surface.

This produces dry discharge air with extremely low relative humidity, which is ducted to the AHU or area being heated to facilitate drying of other moisture control applications. Heat is applied to the remaining 30 per cent of the rotor surface to reactivate the desiccant

material.

The resulting wet air discharge is vented outside. Other advanced features like microprocessor controllers are also incorporated for precision control and maximum operating efficiency.

For more information, please contact:APPIDI Technologies Pvt LtdSurvey No: 123, Jeedimetla VillageQuthbullapur Road , Hyderabad, Andhra Pradesh 500 055Tel: 040-23090494, 23090495 | Fax: 91-040-23090495E-mail: [email protected] / [email protected] / [email protected]

Dehumidifiers

Product.indd 56 20-02-2015 19:28:14


Allegro Pharmachem Equiments offers capsule polishing and dedusting machine.

This machine is an advanced dedusting and polishing tool in production of capsules.

Combination of cGMP design and other engineering features for most efficient method of polishing makes it easier to clean and maintain. The flexibility innate in the machine results in high-efficiency and cleanliness, which can be incorporated into any existing production line.

Auto punch polisher helps improve the surface finish of punches, which leads to improved tablet finish, minimises sticking and prevents corrosion.

During tablet production, punches and dies loose their original finish due to abrasion and powder sticking. The auto punch polisher minimises dependence on operator skill and increase productivity by 20 times.

The machine is fitted with a PLC that allows the user to program the complete cycle.

For more information, please contact:Allegro Pharmachem EquipmentsUnit No: 18, Param Indl EstateNaik Pada, Waliv, Vasai (E), Dist: Thane, Maharashtra 401 208Tel: 022-40146872, 40146873 | Fax: 91-022-40146874E-mail: [email protected]

For more information, please contact:Imperial Pharmachines Pvt Ltd136 Shivkrupa Indl Estate, LBS MargVikhroli (W), Mumbai 400 083Tel: 022-25781989, 25770554 | Fax: 91-022-25780000E-mail: [email protected]

Capsule Polishing & Dedusting Machine Auto Punch Polisher

Tapasya engineering Works Pvt Ltd, Thane, Maharashtra offers Tap mill.

Tap mill is used for high speed milling and sizing of dried granules, powder and wide range of wet and dry materials without special attachments.

This machine operates on the principal of variable force of swing cutting knife edges blades. It is exclusively used in pharma, food, chemical and biotechnology industries.

As co¬mpared to the four common principles of size reduction, which often do not produce controlled size reduction, this machine util ises the principle of variable force swing hammer blades having both knife and impact edges rotating with a carefully selected screen to control size reduction.

For more information, please contact:Tapasya Engg Works Pvt LtdA 212, Road No: 30, Wagle Indl EstateThane (W), Maharashtra 400 604Tel: 022-25822287, 25823250 | Fax: 91-022-25825243E-mai: [email protected] / [email protected]

Tap Mill

Product.indd 57 20-02-2015 19:28:15


events diary

Anti-Counterfeiting Pharma 2015Date: 11th – 12th March, 2015Venue: Marriott Regents Park, London, UK

According to a report by Allied Market Research ‘ the global anti-counter feit packaging market in food and pharmaceuticals is forecast to attain market value of USD 142.7 billion by 2020 from USD 57.4 billion in 2013, growing at 13.9 per cent CAGR during 2013 to 2020. Anti-Counter feiting Pharmaceutical Conference will bring experts from cross-sector organisations together to share their knowledge and experience on the the key issues and latest technological developments. The aim is to foster discussion on how to tackle counter feiting and improve patient safety.

Contact:JasneetTel: +44 (0) 2071129183 / +44(0)[email protected]; [email protected]: [email protected]: www.pharmasfedubai.com

IPHEX & PHARMA Pro&Pack Expo 2015Date: 13th – 15th May 2015Venue: Bombay Exhibit ion Centre, Mumbai

Co- located with PHARMA Pro&Pack Expo 2015, a show for pharmaceutical machinery manufacturers, iPHEX 2015 wil l of fer the industry majors from India and all across the wor ld a great plat form to connect and do business.

This event is one of the largest showcase of Indian pharmaceutical products and technologies to a global audience. More than 480 exhibit ing companies from 18 countr ies are expected at PHARMA Pro&Pack Expo 2015 and iPHEX 2015 whereas 20,000 pharma professional are expected among which 1400 are international buyers.

Contact:Raguveer KiniTel: 91-40-23735462/[email protected]

The Health Industry Summit (tHIS)Date: 15th-18th May, 2015Venue: National Exhibition and Convention Center, Shanghai

The Health Industry Summit (tHIS) – EXPO and Congress is the new umbrella global Pharmaceutical and Medical industry event in Asia, the world’s fastest growing health market. It brings together CMEF, PharmChina and API China in one place at the same time, the only event providing complete coverage of the health industry. It enables leading academics and professionals from around the world to meet and share the latest innovation and thinking on policies & investment, R&D, manufacturing & distribution,education & hospital applications and related services for the industry.

Contact:SophieReed Sinopharm Exhibitions Tel: 0086-1084556604E-mail: [email protected]: www.thishealthsummit.com

QbD in Pharma Development World Congress 2015Date: 16th – 18th April, 2015Venue: Hotel Shivalik View, Chandigarh, India

The event will feature experts who are adept in this science and risk-based approaches, and therefore, will of fer def initive benefits to the scientists from academia and industry working in the domains of Product Development, Process R & D, Scale-up, Manufacturing, Quality Assurance, Global Regulatory Af fairs, API, Excipients, Pharmaceutical Analysis and Technology Transfer.

The speakers will ar ticulate on all the pertinent areas of QbD Implementation including Manufacturing, Formulation, Analytical Development and Excipients.

Contact:Sakshi ModgilMobile: 7696125050E-mail: [email protected]

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bookshelf

Vaccine Design: Innovative Approaches and Novel Strategies (Hardcover)

Authors: Rino Rappuoli, Fabio Bagnoli (Editors)Price: USD 342.00No of Pages: 394 pages

About the Book: In this book, expert international contributors crit ical ly review the current cutt ing-edge research in vaccine design and development. Particular emphasis is given to new approaches and technologies. The book has been divided into two parts. The f irst part reviews the technologies and approaches used to identify, generate, and test new vaccines. Topics include new strategies to identify protective antigens, generation of improved adjuvants, use of alternative immunization routes, improving vaccine safety, and f inding and establishing the correlates of protection. The second part of the book focuses on the development of new vaccines to replace or complement currently available products or for diseases against which prophylactic strategies are missing.

Vaccine Development and Manufacturing (Wiley Series in Biotechnology and Bioengineering) (Hardcover)

Authors: Emily P Wen, Ronald Ell is , Narahari S Pujar (Editors)Price: USD 109.05No of Pages: 464 pages

About the Book: In recent years, there have been tremendous advances in al l aspects of vaccine manufacturing. Improved technology and growth media have been developed for the production of cell culture with high cell density or fermentation. Vaccine Development and Manufacturing wil l serve as a reference on all aspects of vaccine production by providing an in-depth description of the available technologies for making different types of vaccines and the current thinking in faci l i ty designs and supply issues. This book wil l provide insight to the issues scientists face when producing a vaccine, the steps that are involved, and wil l serve as a reference tool regarding state-of-the-art vaccine manufacturing technologies and facil i ty set-up.

Vaccine Adjuvants: Preparation Methods and Research Protocols (Methods in Molecular Medicine) Hardcover

Author: Derek T O’Hagan (Editor)Price: USD 111.57No of Pages: 342 pages

About the Book:Derek T. O’Hagan and a team of expert vaccinologists and pharmacologists thoroughly describe the preparation, characterization, and evaluation of a wide range of alternative vaccine adjuvants for use in preclinical studies. Each chapter careful ly reviews a single adjuvant, and suggests why a specif ic adjuvant might be preferred for a given antigen, depending on what type of immune response is desired. Alternate adjuvant choices are also presented so that researchers can choose those most eff icacious for their specif ic purpose. Comprehensive and highly practical, Vaccine Adjuvants: Preparation Methods and Research Protocols provides an effective guide to making and using vaccine adjuvants.

Bookshelf.indd 59 20-02-2015 19:29:36


ad index

Sr. No Client’s Name Page No

1 Azeotrophy 31

2 B&R Industrial Automation 3

3 Bhavya Polymers 27

4 Bry-Air (Asia) Pvt Ltd 7 & 25

5 Chemtech Events Inside Cover II

6 Emjay Engineers 27

7 Enviro Technologies 25

8 Inos Tech 23

9 Kirloskar Brothers Ltd Inside Cover I

10 Kirloskar Chillers Pvt Ltd 5

11 M K Silicone Products Pvt Ltd 29

12 NNE Pharmplan (India) Pvt Ltd 9

13 Praj HiPurity Systems Ltd Back Cover

14 Reed Sinopharm Exhibitions 17

15 SalesWorth Synergies Pvt Ltd 25

16 Smart I Electronics Systems Pvt Ltd 29

17 SSP Pvt Ltd 19

18 West Pharmaceutical Services Pte Ltd 11

Ad Index.indd 60 20-02-2015 19:30:46

R.N.I. No.: MAHENG/2002/08502. Date of Publication: 26th of every month. Postal Registration No: MH/MR/SOUTH-284/2014-16Posted at Patrika Channel Sorting Office, Mumbai 400001, on 26th & 27th of every month. Total Pages:- 62

pharma bio world february 2015

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