Pathogen safety of plasma‐derived products – Haemate® P/Humate‐P®

Summary. 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.