Module 9 2021

19/03/2021

TOPRA MSc Module: Registration of Biological, Biotechnology and Advanced Therapy Products

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Viral Safety and TSEs

05 April 2019

Anne Stokes, Director TSE and Virus Control, GlaxoSmithKline

Image from Centers for Disease Control and Prevention (CDC)

ENABLINGAND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

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Learning Outcomes

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 Regulatory requirements/expectations in US, EU and other regions with reference to TSE and Virus  The difference between a virus and a Transmissible Spongiform Encephalopathy agent and management of the different risks they present to Biopharms and ATMP’s  The three-pronged approach to virus safety according to ICHQ5A guidelines; Sourcing materials, testing at different stages of production and virus clearance validation  The control framework (risk assessment) for TSE and virus applied to the manufacture of clinical and commercial materials and the risk of product/facility contamination  Newly emerging issues with adventitious agents including SARS-CoV-2.

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