Bob Schrock, Ph.D., Head, Quality Control,Viral Based Therapeutics, Lonza Houston, Inc.
Webinar Topics Will Include:
• Definition of “Potency”: measuring biological activities specific to a viral-based product
• Challenges encountered when developing and validating cell-based potency assays
• Expectations from regulatory agencies and available guidelines to reference
• Potency assay approaches to consider
• Real-world case study of an adenoviral gene therapy product
This 60-minute webinar will demonstrate Lonza's viral manufacturing capabilities in the area of cell-based potency assays and will include a case study that illustrates a timeline from development to validation.