Rational arguments for regulatory acceptance of consistency testing: benefits of non-animal testing over release testing of vaccines.
Authors
Marcel H N Hoefnagel [3]; Paul Stickings [4]; Dean Smith [5]; Carmen Jungbäck [6]; Wim Van Molle [7]; L. Tesolin [8]Keywords
Abstract:
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, …