Alcami Capabilities Update May 2026: Large Molecule

This presentation outlines Alcami’s risk-based approach to the biologic drug substance-to-drug product transition. We evaluate potential impacts on critical quality attributes (CQAs) during compounding, filtration, and filling by leveraging product formulation data and historical expertise.

Through shear studies and filling simulations, we identify optimal parameters for successful tech transfer. For complex operations involving buffer exchange and concentration, we utilize scale-down TFF models to ensure process robustness. We will share proven strategies to mitigate aggregation and interfacial stress across liquid, lyophilized, and pre-filled syringe formats.