Challenges of developing stable high‐concentration formulations for novel biologic modalities
29 Apr 2026
Quality Control & Characterization
- What issues are you faced with when developing high concentration formulations for novel modalities?
- What excipient(s) (amino acids, salts, surfactants, polymers) have you tested or considered to reduce viscosity or self‐association, and how do they affect stability under process conditions?
- How do UF/DF and sterile filtration behave (flux, membrane interactions, Donnan/volume‐exclusion effects) when concentrating your protein, and what strategies mitigate adverse effects?
- Which analytical techniques are most useful for monitoring your protein's behavior at high concentration?
