Challenges and Strategies for Complex Molecules from a CMC Perspective

Bi-/multi-specific antibodies and fusion proteins offer significant advantages over traditional monoclonal antibodies, including enhanced therapeutic efficacy, broader target engagement, and improved pharmacokinetic profiles. However, their structural complexity, molecular heterogeneity, and diverse mechanisms of action introduce unique CMC challenges throughout development and commercialization.

In this BioProcess International webinar, Yang Li, Ph.D., Vice President of CMC Development, discusses how Altruist can overcome these hurdles to accelerate CMC timelines and enable rapid clinical progression for complex molecules. Common challenges—including chain mispairing, aggregation, fragmentation, and complex potency assays—are addressed through optimized vector design, tailored purification strategies, in-depth characterization, and high-resolution analytical methods that support product quality, consistency, and regulatory readiness.

Key Takeaways:

• Understand the key challenges and considerations in CMC development for bispecific/multispecific antibodies and fusion proteins.
• Learn how Altruist addresses core CMC hurdles, including mispaired impurities, aggregation, fragmentation, and complex potency assays.
• Explore how Altruist accelerates CMC timelines and enables rapid clinical progression for complex molecules.