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Webinar 1 Use of Ref Standards in Transition from In Vivo to In Vitro Methods for Vacc Release Tests

Animal-Free Safety Assessment Collaboration

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Webinar 1 Use of Ref Standards in Transition from In Vivo to In Vitro Methods for Vacc Release Tests

39 просмотров · 4 дн. назад
Animal-Free Safety Assessment Collaboration
420 подписчиков
39 просмотров · 4 дн. назад
This is Webinar 1 of a 3-part Biological Reference Materials (BRM) Webinar Series Purpose of the Webinar Series Co-hosted by the Animal-Free Safety Assessment Collaboration (AFSA) and endorsed by the International Alliance for Biological Standardization (IABS), this webinar series will increase awareness and practical understanding of biological reference materials and their role in supporting the transition from in vivo to in vitro methods for vaccine release testing. This webinar series will present the following: Case studies that illustrate how reference standards can support implementation of in vitro methods across different vaccine products and technologies Regulatory expectations during method transitions Real-world examples on the use of appropriate reference standards, including guidance for situations where no reference standard or material yet exists Series Overview The series is designed to move participants from foundational concepts to applied examples, connecting regulatory expectations with practical approaches for adopting in vitro methods in vaccine release testing. Webinar 1 introduces core principles and regulatory considerations, illustrated through DTaP and Hepatitis B examples. Webinar 2 focuses on reference material lifecycle management and transition planning, using Rabies and tick-borne encephalitis (TBE) case studies. Webinar 3 examines the use of reference viruses for next-generation sequencing- (NGS) based adventitious virus detection.