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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

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
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
slide3

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
bpac parvovirus b19
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
industry presentation
Industry Presentation
  • Company data presented anonymously
  • Represented:
    • Alpha Therapeutic Corporation
    • Aventis Behring
    • Baxter BioScience
    • Bayer Corporation
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