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Formulation strategies for physically unstable multi-specific biologics molecules

01 Sept 2026
Formulation & Stability
  • Intrinsic multi-specific liabilities: Have we sufficiently built and leveraged cross‑platform learnings to understand how different multi‑specific formats intrinsically drive instability? 

  • Early screening and platform gaps: How can we close the gap in early developability screening to deliver predictive, scalable insights that translate to formulation and manufacturing success? 

  • Colloidal instability at relevant concentrations: How do we effectively manage colloidal instability at high concentration, including self‑association, viscosity, and phase behaviors such as LLPS and opalescence? 

  • Choice of excipients: What excipient strategies can robustly mitigate aggregation, particle formation, and viscosity while remaining practical and scalable for development? 

  • Phase appropriate development strategy with end to end considerations: How balance speed, robustness, device compatibility, and comparability when selecting the DP presentation? 

Industry Expert
Li Yi, Executive Director, Formulation and Process Development - Gilead Sciences, Inc.