Wolfram Schäfer
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View article: Hepatitis <scp>E</scp> virus: Efficacy of pasteurization of plasma‐derived <scp>VWF</scp>/<scp>FVIII</scp> concentrate determined by pig bioassay
Hepatitis <span>E</span> virus: Efficacy of pasteurization of plasma‐derived <span>VWF</span>/<span>FVIII</span> concentrate determined by pig bioassay Open
Background Hepatitis E virus (HEV) is the leading cause of acute hepatitis throughout the world. Increasing blood component transfusion‐associated HEV infections highlight the need for reliable virus inactivation procedures for plasma deri…
View article: Effective coronavirus reduction by various production steps during the manufacture of plasma‐derived medicinal products
Effective coronavirus reduction by various production steps during the manufacture of plasma‐derived medicinal products Open
Manufacturing processes of all plasma-derived medicinal products (PDMPs) include dedicated virus removal or virus inactivation steps to provide a high safety margin against known or emerging viruses. The recent outbreak of the novel corona…
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: Low hepatitis E virus RNA prevalence in a large‐scale survey of United States source plasma donors
Low hepatitis E virus RNA prevalence in a large‐scale survey of United States source plasma donors Open
BACKGROUND Hepatitis E virus (HEV) is a small, nonenveloped, single‐stranded, RNA virus of emerging concern in industrialized countries. HEV transmission through transfusion of blood components has been reported, but not via plasma‐derived…
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 the purity and stability of Respree…
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 …