Plasma fractionation issues |
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| Authors: | Albert Farrugia Theo Evers Pierre-Francois Falcou Thierry Burnouf Luiz Amorim Sylvia Thomas |
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| Affiliation: | 1. Blood and Tissues Unit, Office of Devices, Blood and Tissues, Therapeutic Goods Administration, PO Box 100 Woden, ACT 2606, Australia;2. International Plasma Fractionation Association (IPFA), Amsterdam, The Netherlands;3. LFB Biotechnologies, Lille, France;4. Human Protein Process Sciences (HPPS), Lille, France;5. Hemobras, Brasilia, Brazil;6. Brazilian Federation of Hemophilia, Sao Paulo, Brazil |
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| Abstract: | Procurement and processing of human plasma for fractionation of therapeutic proteins or biological medicines used in clinical practice is a multi-billion dollar international trade. Together the private sector and public sector (non-profit) provide large amounts of safe and effective therapeutic plasma proteins needed worldwide. The principal therapeutic proteins produced by the dichotomous industry include gamma globulins or immunoglobulins (including pathogen-specific hyperimmune globulins, such as hepatitis B immune globulins) albumin, factor VIII and Factor IX concentrates. Viral inactivation, principally by solvent detergent and other processes, has proven highly effective in preventing transmission of enveloped viruses, viz. HBV, HIV, and HCV. |
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