Integration of models and experimentation to optimise the production of potential biotherapeutics.

Despite decades of clinical and commercial success, the current paradigm for drug discovery and development is still empirical and costly. The many hundreds of therapeutic proteins (TPs) in the development pipeline and the FDA-led quality-by-design initiative represent opportunities to address this issue. Advances in our understanding of cellular mechanisms as well as the physicochemical and biological characteristics of TPs have enabled researchers to develop computational models that analyse or even predict molecular and cellular behaviour under different conditions. Coupled with new analytical tools, these models are increasingly used to systemise and expedite the design and optimisation of protein production processes throughout the discovery and development stages.