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

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, the introduction of in vitro alternatives to replace in vivo release assays...

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Bibliographic Details
Main Authors: Marcel H.N. Hoefnagel, Paul Stickings, Dean Smith, Carmen Jungbäck, Wim Van Molle, Lorenzo Tesolin
Format: Article
Language:English
Published: Taylor & Francis Group 2023-12-01
Series:Expert Review of Vaccines
Subjects:
Online Access:http://dx.doi.org/10.1080/14760584.2023.2198601