Speed and regulatory confidence are critical for the success of modern biologic development. This webinar explores an integrated GMP cell bank manufacturing and characterization strategy designed to compress release timelines without compromising quality or compliance. Risk based testing, accelerated microbial detection, and advanced molecular technologies, such as NGS for adventitious agent testing, can enable conditional and full characterization release in significantly shorter timeframes, saving up to 10 weeks. Real world considerations across MCB and WCB production are discussed to help sponsors accelerate milestones and support long term regulatory success and get to the clinic faster.

You will learn:

• How an integrated GMP strategy for MCB and WCB manufacturing can compress cell bank release timelines
• Where and how risk‑based testing enables efficient characterization while maintaining regulatory compliance
• How advanced molecular methods, including NGS‑based adventitious agent testing, support faster full characterization release to get to the clinic faster

Presenter:

Marian McKee, Ph.D.  Vice President of BioPharma Biosafety Eurofins BioPharma Product Testing

Marian L. McKee, Ph.D. is Vice President of BioPharma Biosafety Testing at Eurofins BioPharma Product Testing in Lancaster, PA, leading biosafety and viral safety testing for traditional biologics, vaccines and advanced therapeutic modalities, with expertise in cell bank characterization, adventitious agent detection, viral clearance, and regulatory biosafety strategy across the product lifecycle. She is a trusted advisor to global biopharmaceutical companies on risk based biosafety testing, viral safety justification, and inspection readiness under ICH and pharmacopeial frameworks. Dr. McKee has played a key role in advancing NGS based adventitious agent detection to complement and modernize classical biosafety testing frameworks and supports biosafety strategies for emerging advanced therapies, applying principles rooted in biologics manufacturing.

Moderator:

Tristan Westover Business Development Manager Eurofins BioPharma Product Testing

Tristan Westover is the Southeast Biologics Business Development Manager at Eurofins BPT and is based in Research Triangle Park, North Carolina. He builds and maintains scientific partnerships supporting biologics CMC and GMP analytical testing programs. With nearly five years of experience partnering with biopharma organizations across the Southeast, he brings a practical, industry focused perspective. Tristan holds a Bachelor of Science degree from Duke University.