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Solve Bulk Harvest Testing Pain Points: From IND Development to Commercial Production
Bulk harvest testing is a key element of viral safety assurance for recombinant biopharmaceuticals, yet its implementation often raises scientific and regulatory questions.
This webinar will outline the scientific rationale for bulk harvest testing and summarize current regulatory expectations, including specific considerations for different expression systems and varying agency perspectives. Recent updates to the ICH Q5A(R2) guideline will be discussed, highlighting opportunities to streamline testing strategies and reduce timelines and costs. Requirements for IND stage products and their transition to commercial testing programs will be explained. The session concludes with two case studies demonstrating how bulk harvest testing data support comprehensive viral risk assessments.
What you will learn:
- The scientific and regulatory rationale
- Current regulatory expectations
- Key updates from ICH Q5A(R2)
- IND vs. commercial testing requirements
- Unique aspects of APAC practices
- Real-world case studies
Presenters
Kerstin Brack, PhD
Senior Director, Regulatory Science, Biosafety Services
Charles River
Olaf Stamm, PhD, MDRA
Technical Business Development Director, Biological Testing Solutions
Charles River
Anurag Tulsyan
Managing Director
Zelle Biotechnology, Pvt. Ltd.