High‐Throughput Biophysical Assays for Developability Assessment

A high-quality developability profile is a key feature for large molecule biological drugs and is typically assessed during the discovery stage of the molecule. Successful screening campaigns of large candidate panels to select a clinical lead utilize a suite of assays that can quickly select or exclude candidate molecules using a very limited amount of material. While there are many critical attributes that inform on developability, including suitable pharmacokinetic and pharmacodynamic profiles, biophysical properties, manufacturing productivity, and acceptable safety, in this chapter, we focus on the application of biophysical assays to assess molecule developability. This review chapter will outline emerging developability workflows with a focus on high-throughput analytics and data processing strategies. An outlook on risk assessment and mitigation strategies to increase the likelihood of success in selecting a clinical lead will be provided.