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

• Main Authors: Marcel H.N. Hoefnagel (Author), Paul Stickings (Author), Dean Smith (Author), Carmen Jungbäck (Author), Wim Van Molle (Author), Lorenzo Tesolin (Author)
• Format: Book
• Published: Taylor & Francis Group, 2023-12-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

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...