Predicting, Avoiding and Mitigating Risk When Developing Biotherapeutics

Developability issues can contribute to the high attrition rate of potential biotherapeutic candidates. Such issues can arise from manufacturability risks due to post-translational modifications and aggregation, and immunogenicity risks due to the presence of T-cell epitopes. There is a critical need to de-risk the candidates as early as possible during development to improve their success rate. The presentation will describe how in silico and in vitro tools can be employed to highlight, predict and mitigate manufacturability, expression and immunogenicity risks, thereby reducing the risk of failure for the development of biotherapeutics.