european biotechnology news 3/2012 - freeexcerpt - are released gm mosquitoes safe?

CENTRAL EUROPE

Novartis poised to enter HCV market with Enanta compound

NORTHERN EUROPE

Norway to use sequencing data in the country’s healthcare system

WESTERN EUROPE

Oxford Nanopore shakes up Next-Gen sequencing market

SPECiAL

BIO-Europe Spring: Antibodies – Unlocking new markets

SOUTHERN EUROPE

Spain leads EU project for iPSCs in cell replacement therapies

EASTERN EUROPE

Bioton joins forces with Actavis to develop biosimilar insulins

SCiENCE & TECHNOLOgy

European Commission presents 2020 roadmap to bioeconomy

EuropeanBiotechnology

Science & Industry News

Nº 3 | Volume 11 | 2012 | 10.00 € | ISSN 1618-8276 | A 60711 |

Are released GM mosquitoes safe?

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Euro|Biotech|NewsN º– 3 | Volume 11 | 2012 3

INtro

T he societal and economic challenges facing Europe and the world are complex and interconnected. The Bioeconomy

Strategy and Action Plan “Innovating for Sustainable Growth: a Bioeconomy for Europe”, which was adopted by the European Commis-sion on 13 February 2012, offers a unique approach to addressing these challenges in a comprehensive way.

In order to reduce heavy economic dependen-cy on fossil resources and focus on mitigating climate change, Europe needs to move towards a post-petroleum society. The Bio economy Strat-egy will contribute to this transition by promot-ing research and innovation into sustainable production and exploitation of renewable raw materials, along with alternative energy and carbon sources. It will pave the way to a more innovative and low-carbon society that recon-ciles food security with the sustainable use of renewable biological resources for industrial purposes, while simultaneously creating new job opportunities. Biotechnology as an enabling technology will play a crucial role in enhancing sustain ability and competitiveness in the EU’s primary production and processing industries. It will also significantly contribute to reducing EU industry dependence on fossil resources, and improve the resource efficiency of produc-tion processes through the use of renewable raw materials (including wastes) and more environ-mentally-friendly bio-based processes.

The Bioeconomy Strategy is based on three complementary pillars. The first is aimed at in-creasing investment in research, innovation and skills. Under the European Framework “Ho-rizon 2020” (2014-2020) Programme for Re-search and Innovation, €4.7bn of funding has been earmarked for bioeconomy research and innovation under the societal challenge “Food security, sustainable agriculture, marine and

maritime research, and the bioeconomy” and for bio technology as an enabling technology. It is estimated that this funding could gener-ate about 130,000 new jobs and €45bn in value added in bioeconomy sectors by 2025, not tak-ing into account other direct and indirect public and private investments into bioeconomy sec-tors. A Public Private Partnership for bio-based industries is under consideration.

The second pillar aims to improve synergies and coherence between priorities of European research and innovation policy and other poli-cies relevant to the bioeconomy. It will provide different platforms to enhance interactions be-tween researchers, policymakers, industries and society, as well as supporting similar initiatives in the EU Member States and Regions. The Strategy will also further develop international cooperation in the area of the bioeconomy.

In its third pillar, the Strategy provides sup-port to new markets and the expansion of ex-isting ones; for example, by promoting the develop ment of standards, sustainability as-sessments and labels for bio-based products that will help facilitate their uptake in consumer markets and by green procurement. This pro-motes both the establishment of networks of in-tegrated and diversified biorefineries, and dem-onstration and pilot plants across Europe. Fi-nally, the Stra tegy promotes the development of science-based approaches that can better inform consumers about product properties (like envi-ronmental sustainability) and aid in the promo-tion of a healthy and sustainable lifestyle.

Five Commissioners have demonstrated their strong commitment to the bioeconomy by co-signing the Bioeconomy Strategy. However, its success will very much depend on the com-mitment of member states, regions, stakehold-ers in the research and innovation community and citizens – like you. B

Editorial

Your role in establishing the real bioceconomy

Maive rute; Director Biotechnology, Agriculture & Food, DG rtD, Brussels

Maive rute was nominated Director for SME policy in the European Commission in 2005. the creation of the Small Business Act for Europe and the launch of the pan-European Enterprise Europe Network are considered the two main highlights of her term. During this period, she also led the Commission’s Lisbon team for Estonia. In 2009, rute took on the responsibilities of Director for Biotechnology, Agriculture and Food research in DG rtD, which also includes fisheries and forestry research.

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Special

Antibodies & marketsEditorial: Domenico Alexakis 31

Intro: Antibodies & Partnering 32

Enhancing ADCC 34

Manufacturing of bispecific mABs 36

Antibodies against Alzheimer’s 38

Upscaling bioprocesses 40

Companion diagnostics for mAbs 42

Armed cancer antibodies 44

Release of transgenic mosquitoes in large-scale studies spurs European debate on safety issues 6

INsIght

Release of GM mosquitos spurs debate on GM safety issues 6

Heard in Brussels 8

EU adopts bioeconomy priorities 10

GMO acreage grows all over the globe 12

RegulatoRy affaIRs

Update on clinical trials 13

Breaking news from the EMA 14

ecoNomIc

Focus on newsflow and dividends 15

Stock markets 16

PeRsPectIVes

Portugal: life after the recession 46

Of mAbs and new immunotherapies 49 RegIoNal News

Northern Europe Denmark, Norway, Sweden 18

Central Europe Germany, Austria, Switzerland 20

Western Europe UK, France, Ireland, Netherlands 22

Southern Europe Italy, Spain, Portugal 24

Eastern Europe Poland, Hungary, Czech Republic 26

The latest high-profile debate between environmental groups and bioengineers con-tinues to heat up. Over the last three years, British firm Oxitec’s release of millions of genetically modified mosquitoes on Grand Cayman island has decimated pop-ulations of the disease-carrying insects there, but that success has come at a price. Eager to avoid a media disaster like the one that occurred with GM crops, many EU scientists are now also calling for clear standards and guidelines.

seRVIces

Partners & Associations 4

Imprint 5

Biopeople News from Tecan, Prosonix, Ablynx, Silence Therapeutics, Biotie, and the Swedish Royal Academy of Sciences 28

Company index 45

Events What’s on in March-April 2012 48

Encore 50

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cover Story

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INsIght EuropE

Genetically modified orGanisms

Trust, transparency & transgenic insects the human race is at war with another species, and has been for thousands of years. Each of us in Europe swats dead dozens of the enemy every summer, and in the tropics they kill thousands of people with infectious diseases hidden within their bodies. As in all wars, the battle for public opinion plays a key role in hostilities, along with the latest high-tech weaponry. the newest front in our battle with bloodsucking insects is now a matter of public debate. Innovative and powerful bioengineering technologies are pro-viding Homo sapiens with a potential game-changer in the war against disease-carry-ing mosquitos. unfortunately, at some point the weapons have to be tested out in the field. Exactly how careful and transparent do researchers have to be in large-scale stud-ies involving transgenic animals?

the supplement, however, these die before reaching maturity. The release of successive waves of transgenic adult male mosquitoes, so the theory, can help decimate popula-tions of the dangerous disease-carriers.

And in fact, the first results from the Carib bean look positive. “We monitored the mosquito population very thorough-ly for several months after the pilot study was conducted, and found an initial reduc-tion in the population of around 80%,” said Bill Petrie, the Director of Cayman’s Mos-quito Research & Control Unit. He also told the country’s news service in January that “these data refute any allegation that the re-leased mosquitoes persisted in the environ-ment.” Fears in the general public might re-volve around being bitten by GM mosqui-toes, but for experts, the persistence of the implanted genes in the wild population would be a worrying indicator that every-thing was not going according to plan.

A grave lack of transparency

Although the experiment has apparently gone well, Oxitec was widely condemned by NGOs and environmental organisations for not being more forthcoming about the study, even though it was approved by the Caymans government. Scientists are also concerned about gray areas and a lack of standards. In a paper published at the end of January in the open-access journal PLoS – Neglected Tropical Diseases, research-ers from the Max Planck Institute for Evo-lutionary Biology took a close look at how different countries cope with oversight and public access to information on large-scale field tests with GM mosquitoes – and found them seriously lacking. In “Scientific stand-ards and the regulation of genetically mod-ified insects”, their assessment of the regu-latory apparatus found that in field experi-ments performed with transgenic insects in the US so far, little was done to inform the public in advance that the tests were taking place, and there was no real public debate on the issue. There was also no estimate of possible hazards prior to the releases in the Caymans, Brazil or Malaysia.

“We noted that public access to scientific information is highly restricted throughout the world, particularly information made

Luminescence is just one trait bioengineers can now build into an insect’s DNA.

Since 2009, Oxford-based bio tech compa-ny Oxitec Ltd has released millions of ge-netically altered Aedes mosquitoes – which transmit both yellow fever and dengue fe-ver – in a field test on the island of Grand Cayman. In 2010 and 2011, the British bio-engineers also began large-scale experi-ments in both Brazil and Malaysia. A long list of other countries where the diseases pose a major health concern are lining up to host field tests of their own. Striking-ly, it took more than a year for the little-publicised studies to begin making head-

lines. But when they did, the ensuing up-roar was loud, and many scientists have sided with environmental groups in voic-ing concerns about inadequate oversight in the emerging field.

The mosquitoes used in the Grand Cay-man study were altered using Oxitec’s RIDL® technology, which produces insects that can only survive if as larvae they are also fed a particular supplement. Larvae born of matings between RIDL and wild-type mosquitoes live for awhile, competing with ‘healthy’ offspring. Without access to

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INsIght EuropE

Claire skentelbery, secretary general of the European Biotechnology Network

Heard in BrusselsM Keeping it local – be afraid of the CJEu

Brussels – In February, I heard of a slight-ly mad and very worrying trend in deci-sions handed down by the Court of Jus-tice of the European Union (CJEU) with regard to IP issues handed up from the national level for clarification. IP is not very exciting to start with, but the more you understand about the situation de-veloping, the more you see Europe back-ing itself into a corner about something that could have major ramifications for commercialisation of technologies.

It all started with IP for antibodies. As everyone in the industry knows, antibod-ies are incredibly complicated items in terms of IP – with a product that cannot be pinned to the wall accurately, and with post-translation modification and envi-ronmental factors influencing structure, activity and effect. This leads to long de-velopment times in groundbreaking reg-ulatory and IP arenas. The supplemen-tary protection certificate (SPC) in the-ory gives 5.5 years of extension beyond the original patent duration, and this has been used by a number of organisations to enable effective biological products to be protected to market. Of course, this is a very challenging area of IP, which was not designed to include biological enti-ties, and which refers strongly to the reg-ulations of the original patent. Increas-ingly, national patent offices are referring tricky cases to the CJEU for clarification, and this is where the wheels are coming off – with very serious consequences for the European commercial environment.Instead of casting light into the darkness, aside from a few notable decisions, the CJEU has instead returned slow, lengthy and impenetrable decisions that make it nearly impossible to make a national de-cision to grant an SPC. Clarification has been requested but actively avoided by the court, a great example being reference to ‘non-European rules governing pat-ents’ but without actually saying which

ones, even when asked a straight ques-tion on the matter.

National authorities are unable to inter-pret the legal way forward. “I am bound to say that I find this reasoning difficult to follow,” says Lord Justice Arnold, and “not only has the Court not answered the question referred, but also the guidance it has provided is not sufficiently clear to enable future disputes to be resolved”.

Translation: it would seem that Europe has knitted itself a time-bomb for extend-ing protection of biological products. The CJEU, through either a profound lack of understanding of the issues or through wilful incompetence, is preventing the successful exploitation of next-generation therapeutics, and can’t be touched.

The price will be paid by European companies trying to develop products, by researchers who have dedicated years to the innovation behind bio logicals and of course by the patients, who may wait much longer for a groundbreaking thera-py. Those products will one day be devel-oped elsewhere and imported into Europe – exactly the opposite of the EC’s drive to create a knowledge-driven economy … and a mess of Europe’s own making. B

available before releases start,” said Guy Reeves, the paper’s lead author, who also pursues fundamental research in how to combat disease-carrying insects effectively with the help of bioengineering techniques. “We argue for transparency – not for trans-parency’s sake – but for clearly articulated strategic reasons that promote acceptance of the value of evaluating this promising technology,” he says.

trying not to repeat mistakes

According to the WHO, up to 100 million people are infected with dengue fever every year. Around half a million of them, mostly children, end up in hospital. Up to 30,000 people die of the disease annually. Yellow fever kills around the same number. While there is an effective vaccine available for yel-low fever, the only way to fight dengue at the moment is through vector control.

Scientists in the field agree that bio-engineered insects could prove an effec-tive weapon in controlling that host vector, but are divided on the best ways to move forward with the research. Oxitec has de-fended its quiet pursuit of large-scale test-ing by pointing out that government agen-cies in the affected countries approved the trials well in advance. And the com-pany’s initial success has paid off in more than scientific terms. In February, Oxitec received £8m in fresh cash from invest-ment fund Oxford Capital, and has also increased staff numbers.

But many other scientists and compa-nies are desperate to avoid a media de-bacle like that surrounding GM crops in Europe. By ignoring public concerns in the early days of that technology, firms like Monsanto drove European consum-ers firmly into the anti -GMO camp, where they have remained to this day. Research-ers active in the field of transgenic insects don’t want to see those mistakes repeated. “While it may appear naïve to argue for pre-release access to accurate scientific in-formation and a high quality multi-disci-plinary approach,” concludes the MPI re-searchers’ paper on standards, “it is in our opinion even more naïve to expect that the development of GM insect technologies will progress far in its absence.” B


CompaNy aNd adVertiser iNdex

4SC AG (GER) ……………………………… 15, 17

aAbbott Laboratories (USA) ………………… 14, 23Ablynx NV (B) ………………………………… 28Accenture plc (IRL) …………………………… 28Actavis Group (IS) ……………………………… 26Actelion AG (CH) …………………………… 17, 50Adocia S.A.S. (F) ……………………………… 16Alfama (PT) …………………………………… 47Algeta ASA (N) ……………………………… 13, 50Altana AG (GER) ……………………………… 17Amgen Inc. (USA) ……………………… 15, 32, 49Amsterdam Molecular Therapeutics (NL) …… 22Angiochem (CDN) ……………………………22, 50Apeiron Biologics (A) …………………………… 21Astra Zeneca (GB/S) …………………………… 50

BBASF Plant Science GmbH (GER) …………… 50Bayer Schering Pharma AG (GER) …………… 43Bayern Innovativ GmbH (GER) ……………… 25Berlin Partner GmbH (GER) …………………… 37BIO.NRW (GER) ………………………………… 41BioAlvo (PT) …………………………………… 47Biocant (PT) …………………………………… 47Biocodex (PT) ………………………………… 47BIOCOM AG (GER) …………………………… 49Biofrontera (GER) ……………………………… 21BioGaia AB (S) ………………………………… 18Biogen Idec (USA) ……………………………… 49Biogenes GmbH (GER) ………………………… 49Biomode (PT) ………………………………… 47Bionor Pharma ASA (N) ……………………… 19Biopartners (CH) ……………………………… 26Biopremier (PT) ………………………………… 47Biosurfit (PT) …………………………………… 47Biotecnol (PT) ………………………………… 47Biotie Therapies Corp. (FI) …………………… 28Bioton S.A. (PL) ………………………………… 26Biotrend (PT) …………………………………… 47BioWin - The Health Cluster of Wallonia (B) … 11Boehringer Ingelheim GmbH (GER) ………… 28Braskem SA (BR) ……………………………… 10Bridge Plus AG (CH) …………………………… 31Bristol Laboratories Ltd. (GB) ………………… 20Bristol Myers Squibb Company (USA) ………… 32BTG plc (GB) …………………………………… 50

CCaixa Capital Biomed (E) ……………………… 25Caixa Capital Risc (E) ………………………… 25Celgene Europe Ltd. (GB) ……………………… 32Cell2B (PT) ……………………………………… 47CellArtis AB (S) ………………………………… 24CEV (PT) ………………………………………… 47ClamiTec (PT) ………………………………… 47CLC bio (DK) …………………………………… 24Cobra Biologics (GB) …………………………… 23CTI Life Sciencs Ltd. (GB) ……………………… 14Cytos AG (CH) ………………………………… 21

dDASGIP AG (GER) ……………………………… 40Desitin Arzneimittel GmbH (GER) …………… 21

NNestle S.A. (CH) ……………………………… 18Neurimmune AG (CH) ………………………… 38nLife Therapeutics S.L. (E) …………………… 25Nomura Code (GB) …………………………… 50Novartis AG (CH) ……………………………20, 28Novartis Europharm Ltd. (GB) ………………… 14Novonordisk A/S ……………………………… 26Novozymes A/S (DK) ……………………… 10, 19Nycomed GmbH (GER) ……………………… 17

oOrdesa Laboratories (E) ……………………… 24Orexo AB (S) …………………………………… 19Oryzon Genetics S.A. (E) ……………………… 24Oxford Nanopore Technologies Ltd. (GB) …… 22

pPAREXEL International GmbH (GER) ………… 32Particular GmbH (GER) ………………………… 27xPharmaMar Zeltia Group (E)……………………… 9Pharmasset (USA) ……………………………… 20Philochem AG (CH) …………………………… 44Polymun Scientific (A) ………………………… 21PregLem SA (CH) ……………………………… 27Preqin (USA) …………………………………… 16ProBioGen AG (GER) …………………………34, 39Prosonix plc (GB) ……………………………… 28ProStrakan (GB) ………………………………… 14

rReed Exhibitions Japan Ltd (JP) ……………… CP3Roche AG (CH) …………………… 13, 32, 36, 50Roche Diagnostics GmbH (GER) ……………… CP4

sSamsung (KR) ………………………………… 32Sandoz AG (CH) ……………………………… 20SANOFI - Aventis (F) …………………………… 26Schering AG (GER) …………………………… 28Sea6 Energy (IND) …………………………… 19Shing Poong Pharmaceutical Co. Ltd. (KR) …… 14SilicoLife (PT) …………………………………… 47Stemmatters (PT) ……………………………… 47Syngenta (CH) ………………………………… 23

tTecan (CH) ……………………………………… 28Technophage (PT) ……………………………… 47Thelial (PT) ……………………………………… 47Theshold Pharmaceuticals Inc. (USA) ………… 21Toscana Biomarkers Srl (IT) …………………… 25TreatU (PT) ……………………………………… 47

UUMN Pharma Inc. (J) …………………………… 18uniQure BV (NL) ……………………………… 22UPM (FI) ………………………………………… 19Uppsala Bio (S) …………………………………… 7

V/WVectron Biosolutions AS (F) …………………… 18VetBioChem (RU) ……………………………… 19Vossius & Partner (GER) ……………………… 49Watson Pharmaceuticals (USA) ……………… 32

DIESSE Ricerche S.r.l. (IT) ……………………… 25Dr. Regenold GmbH (Regulanet) (GER) ……… 42

e/FEBD Group (GER) ……………………………… 33ECBio (PT) ……………………………………… 47Elektrobit Corp. (USA) ………………………… 28Eli Lilly (USA) ………………………………… 16, 26Enanta Pharmaceutical Inc. (USA) …………… 20Equigerminal (PT) ……………………………… 47EuroBioJobs.org (CH) ………………………… 15European Biotechnology Network (B) ………… 30Forest Laboratories Inc. (USA) ………………… 27

GGalapagos NV (B) ……………………………… 15Gedeon Richter Ltd. (HUN) …………………… 27Gene PreDiT (PT) ……………………………… 47GeneBox (PT) ………………………………… 47Genetest (PT) ………………………………… 47Genfit SA (F) …………………………………… 13GenIBET (PT) …………………………………… 47Genmab A/S (DK) ……………………………19, 40Genticel S.A. (F) ……………………………… 13Genzyme Corp. (USA) ………………………… 28Geron Corp. (USA) …………………………… 22Gilead Ltd. (USA) ……………………………… 20GlaxoSmithKline (GB) ………………… 21, 24, 50Grünecker Patent- und Rechtsanwälte (GER) … 12

HH. Lundbeck A/S (DK) ………………………… 19Hanwha Chemical Corp. (KR) ………………… 32HBM Partners AG (CH) ………………………… 16Horizon Discovery Ltd. (GB) …………………… 24Hospira One 2 One (F) ………………………… CP2

iIDA Ireland ……………………………………… 23Illumina Inc. (USA) ……………………………22, 50ImunoStar (PT) ………………………………… 47InfoGene (PT) ………………………………… 47Inspiration Biopharmaceuticals (USA) ………… 25Integromics S.L. (E) …………………………… 24Intradigm Corp. (USA) ………………………… 28Isconova AB (S) ………………………………… 19

J/KJanssen Pharmaceutica N.V. (B) ……………… 19Karo Bio AB (S) ………………………………… 19Kempen & Co (NL) …………………………… 15Kiecana Clinical Research (PL) ………………… 27KPMG (GER) …………………………………… 28

L/mLeica Microsystems (Schweiz) AG …………… 28LISA Vienna Region (A) ………………………… 35Luzitin (PT) ……………………………………… 47Mabion S.A. (PL) ……………………………… 27Matera (PT) …………………………………… 47Merck & Co. (USA) ……………………………32, 50Merck KGaA (GER) ………………………… 21, 28Messe München GmbH (GER) ……………… 13Micromet AG (GER/USA) …………………… 15, 49Monsanto (USA) ……………………………12, 23

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european biotechnology news 3/2012 - freeexcerpt - are released gm mosquitoes safe?

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