Birgit Popp
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View article: Choice of parvovirus model for validation studies influences the interpretation of the effectiveness of a virus filtration step
Choice of parvovirus model for validation studies influences the interpretation of the effectiveness of a virus filtration step Open
Different parvoviruses are used interchangeably as models in validation studies to demonstrate effective clearance of small viruses by filtration in the manufacturing of biotherapeutics. The aim of these experiments was to determine if fil…
View article: Effective inactivation of a wide range of viruses by pasteurization
Effective inactivation of a wide range of viruses by pasteurization Open
BACKGROUND Careful selection and testing of plasma reduces the risk of blood‐borne viruses in the starting material for plasma‐derived products. Furthermore, effective measures such as pasteurization at 60°C for 10 hours have been implemen…
View article: Pathogen safety and characterisation of a highly purified human alpha 1 -proteinase inhibitor preparation
Pathogen safety and characterisation of a highly purified human alpha 1 -proteinase inhibitor preparation Open
Alpha1-proteinase inhibitor (A1PI) deficiency is a genetic condition predisposing to emphysema. Respreeza/Zemaira, a therapeutic preparation of A1PI, is prepared from human plasma. This article describes th…
View article: Pathogen safety of a pasteurized four‐factor human prothrombin complex concentrate preparation using serial 20N virus filtration
Pathogen safety of a pasteurized four‐factor human prothrombin complex concentrate preparation using serial 20N virus filtration Open
BACKGROUND Beriplex P/N/Kcentra/Coaplex/Confidex is a four‐factor human prothrombin complex concentrate (PCC). Here, we describe the pathogen safety profile and biochemical characteristics of an improved manufacturing process that further …