TSE Safety of Serologicals Products: Use in Healthcare

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TSE Advisory Committee
The TSE-Safety of Serologicals Products Use in
Global Healthcare
Presentation by Serologicals Corporation Wayne
E. Vaz
Bethesda, MD, July 2003
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Goals of Presentation

• Raise level of awareness re. pervasive use of
  bovine products in the production of life-saving
  drugs, essential diagnostic assays, other global
  healthcare products
• Present facts supporting the high safety and
  quality of Serologicals bovine-based products
• Work with TSE AC and regulators to further
  develop industry guidelines to assure the
  continued availability of bovine products

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Business Description
Serologicals enables the development of Life
Science Products
Serologicals is a global provider of biological
products and enabling technologies which are
essential for the research, development, and
manufacturing of biologically-based life science
products.
Products antibodies, cell culture supplements,
products for diagnostics research.
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Serologicals Bovine-Based Products

• Bovine Serum Albumin (BSA)
• 3 manufacturing formats, gt25 products
• EX-CYTE (Lipoprotein Fraction)
• Transferrin (Apo Holo)
• Aprotinin
• Prepared Leptospira Media (PLM-5)
• Gamma Globulin (IgG)
• Plasma Diagnostic Base (PDB)
• DNase

• Manufacturing Facilities
• Toronto, Canada
• Kankakee, IL
• Lawrence, KS (under construction)

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Use of Bovine Products in Global Healthcare
Serologicals bovine-based products are used in
the development production of life-saving
FDA-approved drugs, FDA-licensed diagnostics,
medical devices and animal vaccines
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Industry Guidance

• April 19, 2000 FDA update to manufacturers of
  biological products (Kathryn C. Zoon)
• FDA letters (May 3, 1991, Dec. 17, 1993, May 9,
  1996) and guidance document (Sept. 1997) Avoid
  using ruminant-origin materials derived from
  BSE-affected countries, in the production of
  FDA-regulated products intended for humans
• Identify all ruminant materials used in
  production of regulated products, document the
  country of origin and maintain traceability
  records/each lot

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Consequences for Drug Manufacturers Patients

• Regulatory uncertainty re. products under
  development made with bovine ingredients
• Risk of current production of approved drugs
  which use bovine ingredients
• Possible interruption to supply if BSE/U.S
• Bovine-based products provide unparallelled
  performance few attempts to replace these
  products result in lower productivity, higher
  costs

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Serologicals Prion Infectivity Clearance Studies

• Hamster-adapted strain of Scrapie, 263K
• Spike known titers of infectivity prior to key
  process steps titrate infectivity downstream
• In-vivo infectivity assay Golden Syrian
  Hamsters
• Clinical signs gait abnormality, tremors,
  ataxia
• Histopathology to confirm clinical diagnosis
• Protease resistance of transformed prions

Conclusion
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Serologicals Products High Safety, Quality

• Bovine blood low risk of TSE-infectivity
  according to WHO EC Serologicals uses plasma
  or serum for added safety
• Bovines lt30 months old and typically lt20 months
  No BSE reported in cattle lt20 months and uncommon
  under 30 months (DEFRA)
• USDA-approved RMs, USDA-licensed est.
• Manufactured within ISO9002 Registered GMP
  environment
• Prion viral clearance studies
• Similar clearance studies completed by drug
  producer
• EDQM CoS
• Proven track record of safety in global healthcare

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Virus Clearance Studies BSA Product Line
Conclusion 6 Log10 clearance bovine viruses,
3.5 Log10 clearance PPV (porcine parvovirus)
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Summary

• Bovine-based products are critical to the
  production of life-saving healthcare products
• Manufacturers of FDA regulated products cannot
  replace bovine ingredients quickly, easily or
  economically
• High safety and quality of Serologicals products
  supported by low TSE-risk RMs, controlled
  manufacturing, research studies demonstrating
  robust viral prion clearance, track record of
  safety/success
• Serologicals is pleased to work with the TSE AC
  to further develop TSE-risk guidelines covering
  these important products to permit their
  continued use

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Considerations

• In addition to using low TSE-risk RMs, recognize
  the value of prion clearance studies, establish
  min. acceptance criteria
• Require suppliers perform clearance studies to
  demonstrate product safety
• Consider prohibiting sourcing from countries with
  a high incidence of BSE rather than one or two
  cases
• Request that the FDA (and USDA) carefully weigh
  damages to
• end consumers (patients)
• producers of biomedical products (our customers)
• supply chain producers (like Serologicals)

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Serologicals Contacts

• Wayne E. Vaz,
• Director, Corporate Business Development
  wvaz_at_serologicals.com
• Sue Sutton-Jones,
• VP Global Regulatory Affairs, Quality Assurance,
  Compliance, and Medical Affairs
• ssjones_at_serologicals.com