Making Safety a Priority
Over the years, plasma fractionators have made great strides in optimizing the safety of plasma-derived products. The fractionation process inactivates or removes viruses from pools of plasma donations using chemical treatment with pH or solvent-detergent, thermal treatment, and by using physical partitioning (precipitation and filtration).1,2,3
Peer-reviewed studies confirm that most viruses such as West Nile, Flu, Chikungunya, Zika, hepatitis E, and prions are effectively removed during fractionation.4,5,6,7,8,9 Unfortunately, it is possible for some pathogens to make their way through. A stringent selection of donors and donations prior to fractionation was therefore put into place.
Donor selection criteria and mandatory plasma donation testing were steps added to lower the risk of contamination. Serologic testing and highly sequence-specific nucleic acid testing (NAT) are integral to detection of infectious disease genomes that could compromise plasma for fractionation. NAT detects HIV, HCV, and HBV earlier than conventional serological testing therefore reducing the time between infection and early detection, also known as the window period.10
Today, regulatory guidances and international standards of quality published by the Plasma Protein Therapeutics Association (PPTA) require the screening of plasma donations with both serology and 5 NAT or nucleic acid testing for HIV, HAV, HCV, HBV, and Parvo B19.11 The FDA Federal Drug Administration (FDA) and European Medical Agency (EMA) have that requirement if the plasma-derived products are marketed in the US and EU countries.12 The NMPA and most of Asian regulatory agencies currently require only 3NAT.
The plasma industry continues to follow emerging pathogens that might impact the safety of plasma-derived products. In 2000, PPTA established the Quality Standards of Excellence, Assurance and Leadership (QSEAL) Program to provide independent certification of adherence by fractionators.
Grifols is proud to be a leader in the continued efforts to offer NAT plasma screening quality products to our laboratory customers. For more information about Grifols Procleix assays, click here.
1. Roth, NJ, Dichtelmüller HO, Fabbrizzi F, Flechsig E, Gröner A, Gustafson M et al. Nanofiltration as a robust method contributing to viral safety of plasma-derived therapeutics: 20 yearsʼ experience of the plasma protein manufacturers. Transfusion [Internet].2020 Aug:1–14. Link to article DOI: 10.1111/trf.16022
2. Cai K, Gröner A, Dichtelmüller HO, Fabbrizzi F, Flechsig E, Gajardo R et al. Prion removal capacity of plasma protein manufacturing processes: a data collection from PPTA member companies. Transfusion [Internet].2012 Dec;53(9):1894-905. Link to article DOI: 10.1111/trf.12050
3. Dichtelmüller HO, Biesert L, Fabbrizzi F, Gajardo R, Gröner A, von Hoegen I et al. Robustness of solvent/detergent treatment of plasma derivatives: a data collection from Plasma Protein Therapeutics Association member companies. Transfusion [Internet].2009 Sep;49(9):1931-43. Link to article DOI: 10.1111/j.1537-2995.2009.02222.x
4. Burnouf T, Padilla A.Current strategies to prevent transmission of prions by human plasma derivatives. Transfus Clin Biol [Internet].2006 Nov;13(5):320–328. Link to article DOI: 10.1016/j.tracli.2006.11.001
5. Kreil TR, Berting A, Kistner O, JKindermann J.West Nile virus and the safety of plasma derivatives: verification of high safety margins, and the validity of predictions based on model virus data. Transfusion [Internet].2003 Aug;43(8):1023-8. Link to article DOI: 10.1046/j.1537-2995.2003.00496.x
6. Remington KM, Trejo SR, Buczynski G, Li H, Osheroff WP et al.Inactivation of West Nile virus, vaccinia virus and viral surrogates for relevant and emergent viral pathogens in plasma‐derived products. Vox Sang [Internet].2004 Jul;87:10-18. Link to article DOI:10.1111/j.1423-0410.2004.00530.x
7. Leydold SM, Farcet MR, Kindermann J, Modrof J, Pölsler G, Berting A, Howard MK, P Noel Barrett PN, Kreil TR. Chikungunya virus and the safety of plasma products. Transfusion [Internet].2012 Oct;52(10):2122-30. Link to article DOI: 10.1111/j.1537-2995.2012.03565.x.
8. Yue C, Teitz S, Miyabashi T, Boller K, Lewis-Ximenez LL, Baylis SA and Blümel J. Inactivation and Removal of Chikungunya Virus and Mayaro Virus from Plasma- derived Medicinal Products. Viruses [Internet].2019 Mar;11:234. Link to article DOI: 10.3390/v11030234
9. Farcet MR, Lackner C, Antoine G, Rabel PO, Wieser A, Flicker A et al.Hepatitis E virus and the safety of plasma products: investigations into the reduction capacity of manufacturing processes.Transfusion [Internet].2016 Feb;56(2):383-91. Link to article DOI: 10.1111/trf.13343
10. Glynn S A, Kleinman S H, Wright D J, Bush M P.International application of the Incidence Rate/Window Period model. Transfusion [Internet]. 2002 Aug;42:966-972. Link to article DOI: 10.1046/j.1537-2995.2002.00200.x
11. PPTA.QSEAL NAT Testing Standard. PPTA Global [Internet].2013 Jun; Version 2.0: Link to article
12. US Food & Drug Administration. Nucleic Acid Testing to Reduce the Possible Risk of Parvovirus B19 Transmission by Plasma-Derived Products. FDA [Internet]. 2009 Jul. Link to article
This information is intended for physicians and healthcare professionals only.
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