Collaborative Study for the Validation of Alternative in vitro Potency Assays for Human Tetanus Immunoglobulin

Last updated on 22-8-2019 by Anonymous (not verified)

Sci. report, recommendat┬░, guidance doc., directive, monograph

SCIENSANO

Abstract:

The European Pharmacopoeia (Ph. Eur.) monograph Human tetanus immunoglobulin (0398) gives a clear outline of the in vivo assay to be performed to determine the potency of human tetanus immunoglobulins during their development. Furthermore, it states that an in vitro method shall be validated for the batch potency estimation. Since no further guidance is given on the in vitro assay, every control laboratory concerned is free to design and validate an in-house method. At the moment there is no agreed in vitro method available. The aim of this study was to validate and compare 2 alternative i…

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