From cell bank to clinic faster: Integrated GMP manufacturing and characterisation strategies

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

Watch On-Demand