1 / 5

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.

jerome-marshall
Télécharger la présentation

Parvovirus B19

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related