Bioprocess unit operations are optimised to maximise both product quality and yield. The standard development paradigm, consistent with current Quality by Design and process validation guidance, uses single or multiple factor evaluations with scaled down process equipment. These iterative evaluations require significant resource even when using correctly designed multifactorial experiments and automation. An alternative to traditional process development would be to create a system that could ‘self-learn’. The ability to create a self-learning system would enable simplification of development strategy and automatically maintain critical attributes (quality and process) as well as providing ongoing assurance that the process remained in a ‘state of control’.
University Key Personnel: Prof. Nigel Slater and Prof. Steve Oliver
MedImmune Key Personnel: Ray Field, Marcel Kuiper, Richard Turner