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Plasma Protein Therapeutics Association (PPTA)

The Plasma Protein Therapeutics Association (PPTA) is the trade association of private plasma collectors and companies that make medicines from human plasma, such as immunoglobulins, albumin and clotting factors. It says it represents more than 1,100 plasma collection centres in North America and Europe and that its members make about 80 percent of plasma protein therapies in the US and 60 percent of those made in Europe. It runs voluntary quality programmes: IQPP for collection centres (started 1991) and QSEAL for fractionators (started 1997). For prion disease it matters in three ways. It is a named interested party that EMA consults on CJD and plasma medicines. It coordinated the 2013 pooled analysis of more than 200 prion removal studies from member companies, which is the main industry evidence behind the EU reliance on manufacturing steps to remove prions. And it has argued, with blood services and the UK CJD surveillance unit, for ending UK residence deferrals for plasma, then welcomed EMA's 2024 decision to drop them. It is an industry body with a commercial interest in plasma supply. Information only, not medical, legal or regulatory advice.

Key facts

  • PPTA describes itself as representing more than 1,100 human plasma collection centres in North America and Europe and the manufacturers of plasma protein therapies; its members make about 80 percent of such therapies in the US and 60 percent of those made in Europe. It has a European arm (PPTA Europe, with PPTA France and PPTA Deutschland) and hosts the European Plasma Alliance of private European collectors.
  • Its programmes include IQPP (International Quality Plasma Program), QSEAL, the National Donor Deferral Registry and a Patient Notification System.
  • IQPP was started in 1991 as certification of plasma donor centres, and QSEAL in 1997 for fractionators, with QSEAL certification from 2000; QSEAL standards include NAT testing of source plasma for HIV, HBV and HCV and a 60 day inventory hold so suspect units can be pulled back. The US hemophilia medical advisory council (MASAC) urged centres and fractionators to certify in March 2003.
  • The current IQPP standards cover donor qualification, community-based donors, donor safety, viral markers and the deferral registry; the registry records people who test reactive for HIV, HBV or HCV. No IQPP standard on the page deals with CJD, vCJD or prions.
  • The EMA concept paper of 23 July 2009 on updating the CHMP position statement on CJD and plasma-derived and urine-derived products lists PPTA, with the European Haemophilia Consortium, EPPIC and IPFA, as interested parties to be consulted.
  • PPTA was one of seven parties that commented on draft revision 3 of the CHMP paper (consultation 2018 to 2019). Its comment that some countries quarantine products until post-mortem results rule out variant CJD led EMA to add text: where post-mortem differentiation is not possible or not yet available, not recalling can be justified after a risk assessment, with precautionary recall if signs point to the variant form.
  • The 2013 Transfusion paper "Prion removal capacity of plasma protein manufacturing processes: a data collection from PPTA member companies" pooled more than 200 prion removal studies covering precipitation, adsorption, chromatography and filtration steps. Authors came from Baxter, Biotest, CSL Behring, Grifols, Kedrion and PPTA (Brussels). It reported good agreement between independent groups and between biochemical assays and animal bioassays, and concluded that some process steps intrinsically remove prions. Published online December 2012, in print September 2013.
  • A PPTA staff member co-authored a 2023 Vox Sanguinis review with UK blood services, the UK Department of Health and Social Care, IPFA, CSL Behring and the UK National CJD Research and Surveillance Unit, arguing that UK plasma (not fractionated since 1999) is safe for fractionation and asking regulators to revise donor deferral guidance; it cites no reported vCJD transmission through more than 40 million issued UK blood components.
  • On 25 June 2024 PPTA welcomed EMA's revised position that past UK residence is no longer a vCJD risk factor for plasma for fractionation. Its head of global regulatory policy called it the latest of similar changes in the US, UK, Canada and Australia and said it would likely increase plasma donation in Europe.

Timeline

  1. 1991PPTA starts what becomes the IQPP certification of plasma collection centres.
  2. 1997PPTA implements what becomes QSEAL for fractionators; certification from 2000.
  3. 2003MASAC Document 139 recommends IQPP and QSEAL certification.
  4. 2009EMA concept paper names PPTA among interested parties to be consulted on the CJD position statement.
  5. 2012PPTA member company prion removal data collection published online (print September 2013).
  6. 2019Consultation on draft revision 3 of the CHMP CJD paper closes; PPTA is one of seven commenters.
  7. 2023Vox Sanguinis review on UK plasma and vCJD, with a PPTA co-author, published online.
  8. 2024CHMP adopts revision 3, including text added after the PPTA quarantine comment.
  9. 2024PPTA welcomes the EMA decision to drop UK residence as a vCJD risk factor for plasma donors.
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