Pathogen safety of plasma-derived products - Haemate P/Humate-P.
Plasma-derived factor VIII (FVIII) and von Willebrand Factor (VWF)/FVIII concentrates have been successfully used to treat haemophilia since the late 1960s. These products are derived from pools of plasma donations that may contain viral contaminants - including hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV) - and may therefore present a transmission risk to recipients. To ensure the safety of Haemate P/Humate-P, a plasma-derived VWF/FVIII concentrate, donors of plasma are carefully selected and all donations are screened for viral antigens (HBV), virus-specific antibodies (HIV-1/2, HCV) and genomic material [hepatitis A virus, HBV, HCV, HIV-1 and high titres of human parvovirus B19 (B19V)]. As a quality control measure, plasma pools for fractionation are only released for further processing when non-reactivity has been demonstrated in serological and genome amplification assays. The manufacturing process for plasma-derived products, especially the fundamental procedure of pasteurization, is effective in inactivating and/or removing a wide variety of viruses that may potentially be present despite the screening process. This has been demonstrated in virus validation studies using a range of different viruses. New emerging infectious agents, including prions, which potentially pose a threat to recipients of plasma derivatives, are also the subject of safety evaluations. The multiple precautionary measures that are inherent in the overall production process of Haemate P/Humate-P have resulted in an excellent safety record, documented during 25 years of clinical use, and will help to maintain the high safety margin in the future.
Gröner
A
A
CSL Behring GmbH, Marburg, Germany. Albrecht.Groener@cslbehring.com
D017848:Blood-Borne Pathogens / Q000302:isolation & purification*; D003029:Coagulants / Q000592:standards* / Q000627:therapeutic use; D004338:Drug Combinations; D004340:Drug Contamination / Q000517:prevention & control*; D005169:Factor VIII / Q000592:standards* / Q000627:therapeutic use; D006801:Humans; D038301:Virus Inactivation; D014842:von Willebrand Diseases / Q000188:drug therapy*; D014841:von Willebrand Factor / Q000592:standards* / Q000627:therapeutic use
D003029:Coagulants; D004338:Drug Combinations; D014841:von Willebrand Factor; D005169:Factor VIII
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