The updated ICH Q5A(R2) guideline incorporates viral vectors in its viral safety guidance, including the expectation for a viral clearance study for non-enveloped viral vectors. Designing a viral clearance study for a non-enveloped viral vector requires thoughtful consideration of the risk of any adventitious, endogenous or production viruses that might be present as a potential contaminant. Viral clearance steps should be implemented in the manufacturing process that will selectively inactivate or remove potential contaminants without any detrimental impact to the vector. A well-designed viral clearance study will contribute to the assurance of a vector’s overall viral safety on your journey to regulatory approval.
In this webinar, you will learn:
- How to identify the sources of potential viral contaminants and develop steps in the manufacturing process to selectively remove or inactivate them
- The differences between designing a viral clearance study for a non-enveloped viral vector versus a study to support a monoclonal antibody or recombinant protein
- Why a viral clearance study for viral vector may evaluate fewer steps than a study for a monoclonal antibody or recombinant protein
- The existing principles for evaluation of inactivation, filtration and chromatography steps apply to a clearance evaluation for a viral vector product
Speaker
Kathryn Martin Remington, Ph.D.
MilliporeSigma
Technical Consultant
Kathryn Martin Remington, Ph.D. is a member of the field technology management group and provides U.S. clients with technical and regulatory support. Kathy joined the organization in 2010 from Catalent Pharma Solutions where she established a viral clearance program. She was also the section head of the viral validation group for Bayer Healthcare. During her nearly 20 years in viral clearance, she has authored a number of publications on the viral safety of biopharmaceuticals. Kathy earned her M.S. and Ph.D. degrees in microbiology from the University of Montana.
Pharma and biopharma manufacturing
- Pharma and biopharma manufacturing
Duration:1h
Language:English
Session 1:presented June 20, 2024
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