Since its issue in 1999, ICH Q5A(R1) has been one of the key guidelines that shaped the design of virus clearance studies for recombinant protein products. ICH Q5A(R2), published September 2022, includes a number of updates that may impact the design of virus clearance studies in the future.
Key aspects driving these changes use new manufacturing technologies such as continuous processing and new modalities, including cell and gene therapy vectors. This webinar will discuss the updates and review aspects using alternative virus spiking approaches to address clearance for continuous chromatography and how to build virus reduction capacity into the manufacturing process of viral vectors.
In this webinar, you will learn about:
- The key updates in the ICH Q5A (R2) and how these may impact virus clearance study design
- How modified spiking approaches can be used to address virus clearance requirements for continuous chromatography
- Incorporating virus reduction specific steps into the manufacturing process for viral vectors
Speaker
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
- Downstream Processing
Duration:1h
Language:English
Session 1:presented February 28, 2023
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