Plasma fractionation issues.
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.
Farrugia
Albert
A
Blood and Tissues Unit, Office of Devices, Blood and Tissues, Therapeutic Goods Administration, Woden, ACT 2606, Australia. afarrugia@pptaglobal.org
Evers
Theo
T
Falcou
Pierre-Francois
PF
Burnouf
Thierry
T
Amorim
Luiz
L
Thomas
Sylvia
S
D001771:Blood Banks / Q000592:standards / Q000600:supply & distribution; D001781:Blood Component Removal / Q000009:adverse effects / Q000379:methods* / Q000592:standards; D001782:Blood Donors / Q000600:supply & distribution; D001800:Blood Specimen Collection / Q000009:adverse effects / Q000379:methods; D001938:Brazil; D006467:Hemophilia A / Q000628:therapy; D006801:Humans; D017053:Infection Control / Q000379:methods; D018580:Mandatory Testing / Q000379:methods; D010949:Plasma / Q000166:cytology; D011786:Quality Control; D000094902:Blood Banking / Q000379:methods