Chromatography is regularly investigated in clearance studies to assess the capacity to remove viruses. Historically columns were run in batch mode, and the virus validation studies have been designed accordingly. However, many manufacturers are now implementing continuous chromatography to take advantage of the efficiencies and cost savings that this provides. In response, clearance studies have to be modified to take into account the multi-column process and the impact that this has on sample composition, etc.
In this webinar, our experts will discuss new regulatory guidance for continuous chromatography and review case studies where different study designs have been used to investigate virus removal.
In this webinar, you will:
- Get an introduction to the recommendations from ICH Q5A (R2) and other guidelines about the viral safety of continuous chromatography processes.
- Understand the critical parameters that need to be considered when designing a virus clearance study for a continuous chromatography process.
- Get a review of different virus clearance study designs that can be adopted and the advantages and disadvantages of each.
Speakers
Kate Smith
Merck
Kate Smith
Kate Smith is a principal scientist in the viral clearance services team. Before joining BioReliance® contract testing services in 2007, Kate worked in the purification development group at Lonza, Slough for 17.5 years where she was responsible for the management of viral clearance studies supporting worldwide IND and BLA submissions. Kate brings her purification process and manufacturing experience combined with 30-plus years of viral clearance expertise to her role, providing technical support to the clearance teams and our clients based in Europe and APAC.
Steven McDade
Merck
Associate Director, Sales Development, APAC
Steven McDade is an associate director of sales development APAC, responsible for supporting customers on virus clearance capabilities and providing technical and regulatory support. Steven has worked in the biosafety testing field for more than 24 years, 18 with BioReliance® contract testing services. He has worked in a variety of roles including technical sales manager in APAC, business development manager for clearance services, EMEA & Asia, and senior technical specialist for the cell and gene therapy portfolio. Steven graduated with a BSc (Hons) in microbiology from Glasgow University in 1999.
Pharma and biopharma manufacturing
- Pharma and biopharma manufacturing
Duration:1h
Language:English
Session 1:presented January 30, 2024
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