Critical Aspects of Biologics Developability Assessment and Optimization in Early R&D

Performing developability studies has evolved into an indispensable and imperative risk mitigation strategy for biologics R&D. The risk of encountering issues such as product aggregation, degradation, solubility, immunogenicity or lower than expected production titers during later stages of development necessitates early assessment. Thus, addressing developability in early discovery is akin to an insurance policy, ensuring that product development milestones can be met without costly setbacks. WuXi Biologics works with it various clients to integrate developability assessment as early as possible in drug discovery and development.

Utilizing our extensive expertise, 1H-3S developability paradigm and integrated WuXiDEEP™ platform, we stand at the forefront of providing expert solutions to common biologics CMC development and manufacturing issues that may arise if developability and manufacturability of biologics (i.e., monoclonal or bispecific antibodies, fusion proteins, antibody drug conjugates, and other recombinant proteins) is not addressed during the early R&D phase of preclinical candidate (PCC) screening and selection. By incorporating developability assessment across the early discovery continuum, WuXi Biologics helps ensure its clients and partners the successful progression of biologic candidates into development and through to commercialization. This article addresses why, when and how developability studies and lead PCC optimization can be used throughout discovery and CMC development to quickly and cost-effectively bring novel biologics to the clinic and beyond.