Bulk Harvest Testing: Myths, Best Practices, and Common Pitfalls

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 INDstage 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.

Register now to 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

Who should attend:

• QA, QC, CMC, Research Scientist, Upstream, Downstream, BIOPROCESSING, Project manager, C-levels
• Drug Delivery Heads MAbs Scientists Cell Line Developments, Clinical Research Director/Senior Managers GM’s, DGM’s & VP&’s
• Head of Manufacturing – Biopharma Head & Director of Technical Operations Head of Technology Transfer, Technical Operations Heads/Managers
• Production Engineer, Program Technical Leads, Procurement, Purchasing, Sourcing, Business Development Manager

Speakers:

Dr. Kerstin Brack
Scientific Director, Global Biosafety Charles River Laboratories Germany GmbH

Dr Kerstin Brack has been a Scientific Director at Charles River since 2018 and a subject matter expert for biosafety testing of biologicals. She holds a Diploma in Biology from the University of Bremen (Germany) where she subsequently also earned her PhD in Virology.

Olaf Stamm, Ph.D., MDRA
Technical Business Development Director Charles River Biological Testing Solutions

Dr. Stamm holds a doctoral degree in molecular parasitology and a master degree in drug regulatory affairs from the University of Bonn, Germany. He joined Charles River in 2003 and became responsible for the business development activities in Europe and Asia.

Anurag Tulsyan
Managing Director Zelle Biotechnology

Anurag Tulsyan is the founder and Managing Director of Zelle Biotechnology Pvt. Ltd., a premier organization at the forefront of the Indian Biotech sector for over 21 years. Zelle is a pivotal force in the development and manufacturing of biologics, specializing in the strategic positioning of advanced technologies within the Indian market.