Rational arguments for regulatory acceptance of consistency testing: benefits of non-animal testing over release testing of vaccines.

Last updated on 19-12-2023 by Wim Van Molle

Public Access


Peer reviewed scientific article




INTRODUCTION: There are rational arguments to replace existing in vivo potency and safety assays for batch release testing of vaccines with more advanced non-animal techniques to measure critical quality attributes. However, introduction of in vitro alternatives to replace in vivo release assays of authorized vaccines is challenging. AREAS COVERED: This report describes the hurdles encountered in substituting assays and ways to overcome these and provides arguments why more advanced alternatives are superior, not only as tool to monitor the quality of vaccines but also from a practical, …

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