Our team of viral clearance specialists can help you troubleshoot problems in your viral clearance studies and beyond - "Don't Panic!"
We will discuss potential issues that can arise during viral clearance study design and execution and strategies to mitigate certain risks. Even the strongest study design may encounter issues with sufficient clearance to reach the target safety expectations. Join us to learn how to troubleshoot these and manufacturing deviations that impact viral safety.
In this webinar, you will learn:
- About key risk areas in executing viral clearance studies
- How to mitigate risks in designing viral clearance studies
- What to do if you have insufficient clearance
- How to deal with manufacturing deviations potentially affecting viral safety
Speakers
Kathryn Martin Remington, Ph.D.
Merck
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.
Kate Smith
Merck
Kate Smith
Kate Smith is a principal scientist in the development services team, supporting clearance services. Prior to joining Merck in 2007, Kate worked in the purification development group at Lonza, Slough for 17.5 years. Kate brings her purification process and manufacturing experience combined with 30+ years of viral clearance expertise to her role, providing technical support to the clearance teams and our clients based in Europe and APAC.
Pharma and biopharma manufacturing
- Downstream Processing
Duration:49min
Language:English
Session 1:presented March 3, 2022
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