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Parvovirus B19

Parvovirus B19. PPTA Approach to Reducing Parvovirus B19 Load In Fractionation Pools. Barbee I. Whitaker, Ph.D. Senior Director, Standards and Certification Plasma Protein Therapeutics Association. History.

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Parvovirus B19

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  1. Parvovirus B19 PPTA Approach to Reducing Parvovirus B19 Load In Fractionation Pools Barbee I. Whitaker, Ph.D. Senior Director, Standards and Certification Plasma Protein Therapeutics Association

  2. History • 1998-1999 Industry begins to assess impact of various strategies on detection and removal of Parvovirus B19-reactive units - opts to pursue differential identification and removal of high-titer units • Q4 1999 FDA proposes strategy for limiting viral loads in plasma manufacturing pools based on information gathered during the investigation of seroconversions associated with S/D plasma • Q4 2000 Release of the WHO International Standard for Parvovirus B19 DNA (99/800) at 5 x105 IU/vial • Q2 2001 Plasma Protein Therapeutics Association (PPTA) issues voluntary standard for manufacturers

  3. PPTA Voluntary Standard Objectives Time Frame • Reduce further the potential risk of Parvovirus B19 transmission • Maintain protective antibody titers that contribute to efficacy of Ig products • Allow independent strategies for screening and load reduction • Limit viral loads in plasma manufacturing pools to levels below 105 IU/mL • Continue research on the inactivation and removal of non-enveloped viruses • Implement testing of incoming plasma no later than end of 2001 • Implement manufacturing pool testing and control point no later than July 01, 2002

  4. BPAC: Parvovirus B19 • September 1999 BPAC • Recommendation to treat parvovirus B19 as in-process control testing • Studies to validate clinical efficacy of B19 NAT under IND for plasma for further manufacture not required • Validation as an analytical test only • No clinical correlates if no decisions regarding donor or recipient management are taken

  5. Industry Presentation • Company data presented anonymously • Represented: • Alpha Therapeutic Corporation • Aventis Behring • Baxter BioScience • Bayer Corporation

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