Objective

Protein-based biopharmaceuticals are susceptible to unfolding, mis-folding and aggregation by environmental perturbations that include hydrodynamic flow. Aggregation thus poses an enormous challenge to biopharmaceutical development, production, formulation and storage. To address this problem we describe an in vivo method to rapidly assess candidates for developability and an in vitro method to assess candidate manufacturability or process suitability for the manufacture of aggregation-prone biopharmaceuticals.