isia /jaact meeting€¢international association of serum producers, suppliers and customers,...
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• What is ISIA ? • A brief history of serum use • ISIA product characterization programs
– Standardization – Traceability – Origin testing – Risk mitigation
• Regulatory efforts
Agenda
• International Association of serum producers, suppliers and customers, founded in 2006
• Members supply more than 90% of all animal serum used globally
• Members are also major suppliers of other animal derived products
• Protein, Antibodies, Enzymes, etc. – Expanded mandate includes all animal derived products
• Currently 57 members – All major suppliers – Several large end-user companies
International Serum Industry Association
ISIA Global Membership
ISIA Mission
• ETHICS - ISIA shall establish, promote and assure compliance
with uncompromised standards of excellence
and ethics in the business practices of the
global animal serum and animal derived
products supply industry.
• SAFETY AND SAFE USE - Primary focus will be on safety and safe use of serum and animal derived products through proper origin traceability, truth in labeling, and appropriate standardization and oversight.
• EDUCATION - Work to educate stakeholders on the scientific
foundation of the safe use of serum and animal
derived products.
• Animal serum is used extensively in » Life science research
» Production of human and animal vaccines
» Production of biopharmaceuticals
» Production of diagnostic products
• Total liters of FBS is in excess of 700,000 per annum – Liters of other serum are in vastly in excess of this number
• The Biotechnology industry is a multibillion dollar business affecting healthcare worldwide relying extensively on serum and animal derived products as essential raw materials
Industry Background
• Fetal bovine serum (FBS) has had an impressive
historical validation after more than 65 years of safe use
– Salk Vaccine in the early1950 • No thing else has the same broad spectrum cell growth promoting capabilities • FBS is still the media additive of choice for use in basic research applications
The demise of FBS has been predicted
since the early 1960s
A Brief History
• Over time, concerns have arisen over utilization of animal derived materials in healthcare related manufacturing – Guidance from major regulatory bodies against their
use any time in the last 20 years • Considerable efforts have been made to avoid the
use of animal derived materials with some success – Variability exists in what works for what
• Anyone developing a new process will try to avoid using serum and animal derived materials – But it doesn’t always work
Where are we now?
• What are the alternatives – “defined” – “serum-free” – “chemically defined”
• Lack of clarity on what these terms mean
– “Serum free” may actually contain serum fractions – Chemicals may be produced using animal derived
components • How far down the chain needs to be “animal
free” – How do you audit for that? – Issues with plant materials?
• Plant and animal
Concerns
• By-product of the meat industry – All serum comes from animals deemed fit for human consumption
by competent government authorities
– Fetuses come from dams deemed fit for human consumption • These materials do NOT become part of the food chain!!
– Material from many animals is pooled • Possible viral contamination
• Biotechnology companies prefer serum from certain geographies based on disease prevalence and rigorous infrastructure – FMD, BSE and other infectious agents
– NZ, Australia and USA preferred
Serum Sourcing
• Some things still work best with serum • Primary cells • Some Cells producing extensively modified proteins • Legacy Products (cost to switch) • Products that need to happen quickly
• Demand for serum and other animal derived components continues to increase,
suggesting that they are not going away
So ….how do we use these materials safely and
effectively?
However….
• Standardization of definitions – Minimize customer confusion – Just revised
• Standardization of testing
– USP collaboration • Chapters <1024> and <90> • Fetal bovine serum standard
– Under revision
Product Characterization
• Current Critical Programs –Traceability –Origin testing –Gamma Irradiation
Product Characterization
Why the program works!
• Independent Audit
• Covers all transactions
• in the company
– Not just those for a specific customer
• Focuses on each handoff
– What came in at what price ?
– What went out at what price ?
• Certification not available for purchase
Scope of Traceability
• What happened to the product every step of the way from the abattoir to the customer
• Not just Origin
• Paperwork for exportation
• What kind of serum is it ?
– Blending of serum types and origins
– Serum alternatives
• Has it been treated
• Does it comply with all ISIA requirements
Certification is granted for three years No historic claims
Traceability Certified Companies
• Life Science Production
• Moregate Biotech
• Newman Biotech Australia
• Proliant Health & Biologicals
• River City Biologicals
• Rocky Mountain Biologicals
• VWR/Seradigm
• SeraTec LLC
• Serum Technologies
• Vacca Biologics LLC
• Abattoir Basics Company
• Animal Technologies Inc.
• Atlas Biologicals
• Axenia Biologix
• BioArra
• Biomin Biotechnologia
• Boval BioSolutions
• By Productos S.A. de C.V.
• Central Biomedia Inc
• GE Healthcare
• Gibco Thermo Fisher Scientific
70% of companies that have been members for more than 2 years
are certified or in the certification process
Status
• Increasing awareness and acceptance of program
– Australian government
• Ongoing effort to keep current through program revisions
• Testing methods under
investigation as addition
to the program
Geographic Origin
There have been hints!
• In 1997 we became
aware that strontium
isotopes might provide an indication of geography of origin………..
• In 2013 we became aware that heavy water isotopes were being used to determine geographic origin for other materials
Isotopic Testing
• In 2014 we heard about – How the heavy isotope technology
works and that the technology was valid • Origin of hamburgers in the USA!!
• We designed a pilot study to investigate heavy isotopes with samples from known geographic origin
• We also identified another testing method using trace elements and set up another another pilot study
Why are we interested?
87Sr/86Sr
The application of stable
isotope and trace
element analysis can
distinguish
materials that are
chemically identical.
2H/1H
18O/16O
13C/12C
15N/14N
Current Comparison
• Further analysis confirms better
resolution using trace elements
• Current results give 99%
certainty for geographies tested with
more than150 samples tested so far
• We are working to define an industry
data base and develop a program to
identify geographic origin
Current Status
• After considerable investigation and discussion
• We are also monitoring for other technologies to determine origin and age of source
• Antibody based methods
We are in the process of finalizing
an agreement to develop an
industry wide trace element data
base
Future of Traceability
• Combination of testing and paperwork audit will strengthen the program
– Continued focus by ISIA
• Increased focus from customers and regulators will also strengthen the program
Gamma Irradiation Task Force
• A proposal was made in October 2015 at a meeting with US regulators to allow FBS irradiated outside the USA to be imported
• All parties knew there was a need to understand this subject better
• ISIA volunteered to work on this project
• Several months were spent recruiting experts – First meeting January 2016
©2016 ISIA Confidential & Proprietary
What is the concern?
• Many customers, suppliers and others do not fully understand gamma irradiation
• Although not perfect, ISIA recommends Gamma Irradiation as THE method of choice for post manufacturing treatment of serum
• “Suppliers are secretive”
• “There don’t seem to be any rules
about how the process is validated”
• “Gamma kills all viruses”
• “All the big suppliers have their own
irradiation facilities”
Task Force Participants
Participant Affiliation Representing
Sue Brown TCS Biosciences Supplier
Bart Croonenborghs Sterigenics Irradiator
James Dunster Moregate BioTech Supplier
Debbie Elms Thermofisher Scientific Supplier
Randy Fitzgerald Proliant Supplier
Greg Hansen GE Healthcare/HyClone Supplier
Karl Hemmerich Ageless Processing Technologies End-users
Huw Hughes Zoetis End-users
Robert J. Klostermann Merial End-users
Ray Nims RMC Pharmaceutical Solutions End-users
Mark Plavsic Torque End-users
Andy Pratt GE Healthcare End User
Mara Senescu STERIS Irradiator
Pierre Leonard GSK End User
Martell Winters Nelson labs End User
Marc Wintgens Excellencia End user
©2016 ISIA Confidential & Proprietary
Approach
• It was agreed that
– We would not wait until this was perfect or totally complete to begin publishing
• Or it might never happen…...
– The task would be broken up into several parts
– These parts would stand alone and be published as ready
• FDA requested that this be freely available!
– We might turn this work into a standard eventually
©2016 ISIA Confidential & Proprietary
Areas of Focus
The task is currently broken into 6 parts with different experts taking the lead
FOCUS LEAD STATUS
Introduction to Gamma Irradiation and Serum
RJV and Karl Hemmerich Published
Effect of Gamma Irradiation on viruses
Mark Plavsic and Ray Nims Punlished
Dose mapping and validation Andy Pratt and Bart Croonenborghs
Will be published today!!
Effect of gamma irradiation on polymers
Karl Hemmerich and others Almost final
Product Maintenance through the process
Sue Brown and Mara Senescu Outline complete
What does all this mean? TBD Waiting for solid drafts of first 5
©2016 ISIA Confidential & Proprietary
Links to Published Papers
©2016 ISIA Confidential & Proprietary
Gamma Irradiation of Animal Serum : An Introduction http://www.biotechnoblog.net/XTQ53/J152-Versteegen-HTML/J152-Versteegen-HTML.html
Gamma Irradiation of Animal Serum : Validation of Efficacy for Pathogen
Reduction and Assessment of impacts on Serum Performance http://www.biotechnoblog.net/XTQ53/J152-Plavsic-HTML/J152-Plavsic-HTML.html
Gamma Irradiation of Frozen Animal Serum : Dose Mapping for Irradiation
Process Validation Coming today
• The blood derived products industry is considerably more complex than expected by non-participants
• ISIA is committed to the simplification and global harmonization of appropriate regulation
• ISIA believes that education should precede regulation
• Failure to educate has led to complexity and impracticality of regulations
Community Relations Philosophy
• November 2006 - ISIA begins our outreach and educate program • First meetings with SANCO, DEFRA and others
• Over time ISIA has become an active and credible partner, working as a single point resource with regulatory agencies and associations worldwide:
• Working to strengthen the understanding of the use of serum and blood derived products
• Helping to clarify safety related issues
• A source for information that is not always openly available or simple
– Guidance Document
• Dramatically expanded network • Associations
• Member States
• World Bodies
• Regulators
Community Relations
Join us May 3 and 4th 2017 in
Hong Kong for the
12th Annual ISIA Meeting
Information available at
www.serumindustry.org
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