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Overview

The virus validation of three steps of Biotest Pharmaceuticals IGIV production process is described here. The steps validated are precipitation and removal of fraction III of the cold ethanol fractionation process, solvent/detergent treatment and 35 nm virus filtration. Virus validation was performed considering combined worst case conditions. By these validated steps sufficient virus inactivation/removal is achieved, resulting in a virus safe product.

01 Jan 1989·Beitrage zur Infusionstherapie = Contributions to infusion therapy

[Virus safety of labile plasma products from the German viewpoint].

Review

Author: Stephan, W

Unstable plasma derivatives are sterilized in Germany according to three methods. Combined treatment with beta-propiolactone + UV irradiation: in use at Biotest since 1968; Pasteurisation in sulution, 10 h at 60 degrees C in the presence of a maltose-glycin stabilizer; in use at Behring Werke since 1980; Treatment with solvent + detergent (tri-n-butyl phosphate + Tween 80 (sodium cholate]: in use at DRK Hagen and Biotest since 1987/88. The safety of unstable plasma derivatives sterilized according to these methods has been shown in studies in chimpanzees as well as in clinical studies.

Contributions to infusion therapy

Virus safety of labile plasma products from the German viewpoint

Author: Stephan W

Unstable plasma derivatives are sterilized in Germany according to three methods. Combined treatment with beta-propiolactone + UV irradiation: in use at Biotest since 1968; Pasteurisation in sulution, 10 h at 60 degrees C in the presence of a maltose-glycin stabilizer; in use at Behring Werke since 1980; Treatment with solvent + detergent (tri-n-butyl phosphate + Tween 80 (sodium cholate]: in use at DRK Hagen and Biotest since 1987/88. The safety of unstable plasma derivatives sterilized according to these methods has been shown in studies in chimpanzees as well as in clinical studies.

100 Deals associated with BPC Plasma, Inc.

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Pipeline

Pipeline Snapshot as of 23 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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