Module 9 2021

19/03/2021

Learning Outcomes

The picture can't be displayed.

 Regulatory requirements/expectations in US, EU and other regions with reference to TSE and Virus Guidelines  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.

29

Virus Safety Regulatory Guidance

The picture can't be displayed.

1. a. b.

European Guidelines

European Pharmacopoeia 8.0 : 5.1.7 Viral Safety

CHMP Production and Quality Control of Monoclonal Antibodies (1995).

c. CHMP Note for guidance on virus validation studies (1996): The design, contribution and interpretation of studies validating the inactivation and removal of viruses. CHMP/BWP/268/95 d. ICH Harmonized Tripartite Guideline Q5A(RI)Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin (ICH Steering Committee March 1997 (RI)-September 1999) ICH Harmonized Tripartite Guideline Q5D Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products’ (CPMP/ICH/294/95 July 1997). f. EMA-CHMP/BWP EMA Guideline on Virus Safety Evaluation of Biotechnological Investigational Medicinal Products (February 2009) 2. USA (FDA) Guidelines a. FDA Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use (CBER, FDA Feb 1997). b. FDA Points to Consider in the Characterization of Cell Lines used to Produce Biologicals (CBER July 1993) 3. Japan Guidelines a. Japanese Pharmacopoeia 16 th Edition (MHLW Notification No. 519 dated on 27- September-2012). Japanese Ministry of Health, Labor and Welfare. e.

30

30

15