Advancing With Confidence: Smarter CMC Strategies To Accelerate Next-Generation Biologics To The Clinic

Developing novel antibody therapeutics, especially bispecifics and other advanced formats, offers exciting new treatment options but also introduces unique challenges in Chemistry, Manufacturing, and Controls (CMC). These hurdles can lead to costly delays and even program failure on the path to the clinic. Success hinges on more than just solving individual technical issues; it requires a strategic understanding of how early design choices, process development, and quality considerations all intertwine throughout the development lifecycle.

At Lonza, we've successfully guided numerous next-generation biologics from early development through to first-in-human (FIH) manufacturing. This experience provides a clear perspective on common program stumbling blocks and how the right CMC strategy is crucial for maintaining timelines without compromising quality or regulatory compliance.

This webinar features new, real-world case studies demonstrating practical methods for anticipating and overcoming these complex challenges. Gain actionable insights into navigating the complexities of modern biologics development and the strategies necessary to deliver innovative therapies to patients more efficiently.

Key Outcomes

• Avoid Common Pitfalls: Recognize where next-generation biologic programs often falter on the way to the clinic and understand how proactive CMC strategies can keep development timelines on track.
• Accelerate Progress: Discover practical approaches and strategies that reduce risk and accelerate development, spanning from cell line development to IND-enabling GMP manufacturing.
• Gain Strategic Insight: Review new real-world case studies to gain insight into the decision-making frameworks that effectively guide next-generation molecule programs from early development through to FIH manufacturing, including crucial lessons learned.