Biologics such as monoclonal antibodies and gene therapies are a significant portion of the therapeutics market. ICH Q5A is a globally harmonized guideline outlining regulatory expectations for viral risk mitigation in biologics manufacturing. It is in the process of being revised and encourages the use of Next Generation Sequencing (NGS) and PCR-based technologies. In a short survey of the industry, concerns were raised about uncertainty regarding the implementation and consequent regulatory acceptance. This presentation will discuss the strategies for implementing NGS and PCR-based tests at different manufacturing process steps and the requirements for regulatory acceptance.
In this webinar, you will learn about:
- Highlights of the draft revision
- Updated testing strategies for key process steps in biologics manufacturing, based on the ICH Q5A revision
- The benefits of modified testing packages
- How to ensure regulatory acceptance
Speaker
Manjula Aysola, Ph.D.
{hcompany}
Senior Regulatory Consultant
Manjula Aysola is a senior regulatory consultant in the global regulatory management team. She is an expert on regulatory requirements for quality control of biopharmaceuticals including cell and gene therapies, and she has expertise in regulatory expectations for single-use manufacturing systems and cell/gene therapies manufacturing. With {hcompany} for more than 16 years, Manjula led several R&D projects for bioreactor process development and cell culture media evaluations for stem cell therapies with the organization.
She was previously with Millennium Pharmaceuticals, focused on oncology target and biomarker discovery. Manjula earned her M.S. degree in genetics from Clemson University.
Pharma and biopharma manufacturing
- Cell therapy manufacturing
Duration:30min
Language:English
Session 1:presented March 14, 2023
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