Developability assessment as an early de-risking tool for biopharmaceutical development

Increasing attrition of therapeutic candidates during preclinical and clinical development affects productivity and causes spiraling costs, negatively impacting the development of new treatments. For biopharmaceuticals, product design, lead selection and manufacturing process development constitute significant areas of risk because of their decisive influence on product quality, biological activity and safety, as well as cost of goods. Risk-management developability assessments, introduced early on in development, can help identify and address potential causes of attrition in preclinical and clinical stages related to product manufacturing, safety, delivery and efficacy issues. This article discusses the utilization of in silico and in vitro surrogate assays early on in development as part of a comprehensive developability assessment for novel biotherapeutics, incorporating a closer interaction between discovery and development functions. It further suggests how such approaches can have a significant impa...