Application of Biophysics to the Early Developability Assessment of Therapeutic Candidates and Its Application to Enhance Developability Properties

The emerging technologies in protein engineering and the greater demand for next-generation protein therapeutics with enhanced efficacy, safety, reduced immunogenicity, and improved delivery are translating into increased nomination of more extensively engineered, difficult to develop candidates for development. Recent advances in protein structure, stability, and function relationship combined with advances in biophysics are enabling more comprehensive and accurate developability and manufacturability screening during early research stages. This chapter focuses on current and future challenges in developing therapeutic biological drugs and the application of novel biophysical tools to screen and improve potential developability properties. Based on stage-related requirements like predictability, speed, limited material, and resource availability, the suitability and application of various biophysical tools are discussed. Two case studies are provided to demonstrate the value of such an early risk assessment.

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