This webinar will shed light on the recent changes to ICH Q5A for viral safety evaluation, whilst summarizing the key updates.
Overview
To detail the recent revisions to ICH Q5A for viral safety evaluation of biotechnology products derived from cell lines of human or animal origin, with specific example testing packages provided. Viral safety evaluation is a critical aspect in the production of biologics and is a significant regulatory requirement to ensure product safety and compliance.
Objective
The audience will learn about the recent changes adopted by ICH, to Q5A (Revision 2), for viral safety evaluation. Since the previous version has been in place since 1999, an update was necessary to account for advancements in analytical technology, manufacturing processes and the emergence of more advanced therapies, such as gene therapy. This presentation will summarize the key updates.
Agenda
- ICH Q5A viral safety evaluation principles
- Review of changes in Revision 2 of ICH Q5A
- Example biosafety testing package in accordance with ICH Q5A
- Q&A
Target Audience: The webinar is aimed at all manufacturers and developers of biopharmaceuticals, particularly monoclonal antibodies (including biosimilars), therapeutic proteins and genetically engineered viral vectors that are amenable to the viral clearance process, such as AAV.
Language: English
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Volcán 150, Piso 5,
Col. Lomas de Chapultepec Tercera Sección, 11000,
Miguel Hidalgo, Mexico City, Mexico