Manufacturability and Developability Assessment as the Technical Foundation of a Strong Biologic Candidate

In this article, our expert Michael Hodskinson, Ph.D., discusses why manufacturability and developability assessment are critical foundations for successful biologic candidate selection. They highlight how early in silico sequence analysis, structural assessment, experimental expression, and analytical characterization can identify potential liabilities that may impact stability, product quality, manufacturability, and overall program feasibility. The article also explores how combining developability data, expression performance, and immunogenicity risk assessment enables more informed progression decisions, helping teams de-risk development, prioritize stronger candidates, and improve the likelihood of successful advancement to later-stage development and manufacturing.