Part Two: Developability & Stability‑Led Engineering to Derisk Formulation, CMC & Further Downstream Development
The second half of the seminar day investigates how formulation and CMC strategies informed by FDA-approved bispecific and multispecific antibodies can accelerate development and derisk downstream challenges.
Attendees will gain insights into defining optimal formulation design space, mitigating aggregation risks, and applying stability-first approaches to streamline CMC readiness. Complementing this, the session will examine potency assay development for complex biologics, highlighting analytical challenges, assay robustness, and how data-driven insights can guide formulation and process decisions, equipping attendees with practical lessons for more efficient, developable multispecific programs.