Pathogen safety of Beriate~R

摘要

Plasma-derived factor VIII (FVIII) concentrates have been used successfully to treat haemophilia A since the late 1960s. To ensure the pathogen safety of the plasma-derived FVIII concentrate, Beriate~R (formerly Beriate~R P), donors of blood/plasma are carefully selected and all donations are screened for hepatitis B virus surface antigen (HBsAg), antibodies against HIV types 1 and 2 (HIV-l/HIV-2) and hepatitis C virus (HCV), and genomic material of hepatitis A virus (HAV), hepatitis B virus (HBV), HCV, and for high titres of parvovirus B19 (B19V). As additional quality control, 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 Beriate~R comprises dedicated virus reduction steps such as pasteurization and the recently introduced virus filtration step, resulting in effective inactivation of various enveloped and non-enveloped viruses and effective removal of viruses and prion material larger than the mean pore size of the virus filter (19 nm). The effectiveness of these production steps has been demonstrated in virus and prion validation studies using a range of different viruses and prion preparations. The multiple precautionary measures inherent to the overall production process for Beriate~R (and its predecessor Beriate~R P) are reflected in an excellent safety record documented during 20 years of clinical use with no proven record of virus transmission, even before the introduction of the virus filtration step. Continued improvement of safety measures according to scientific knowledge and regulatory guidance maintains and even enhances the excellent safety profile of Beriate~R.