Key result
Processing of Factor VIII concentrates resulted in an overall Hepatitis A virus clearance of > 8 log, with contributions from antibody neutralization, cryoprecipitation, and lyophilization.
Population
Factor VIII concentrate production process spiked with Hepatitis A Virus (HAV)
Design
Preclinical
Authors
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May support viral safety of Factor VIII manufacturing; leaves open human applicability without further validation.
Effect estimate: > 8 log clearance
The production process for Factor VIII concentrates effectively clears >8 log of Hepatitis A virus, primarily through antibody neutralization, cryoprecipitation, and lyophilization.
Hamman et al. (1994) studied Hepatitis A Virus (HAV) transmission potential in pooled plasma products. Factor VIII concentrate production steps (solvent-detergent treatment, anion-exchange chromatography, cryoprecipitation, lyophilization) was evaluated on HAV clearance (> 8 log clearance). Processing of Factor VIII concentrates resulted in an overall Hepatitis A virus clearance of > 8 log, with contributions from antibody neutralization, cryoprecipitation, and lyophilization.
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