The Application of Advanced Control and Model Based Strategies to Biopharmaceutical and Pharmaceutical Processes

Pressures are increasing to develop, optimise and scale-up processes in minimal time frames whilst maximizing manufacturing related process understanding (QbD). In turn strategies such as process control and modelling are emerging as powerful platforms to compliment and maximise the output from current experimental programs.

Presented are novel model based control strategies that enable the streamlined development, scale-up and scale-down of bio/pharmaceutical unit operations. Cell culture and crystallization examples will be shown where the interrogation of these process development platforms has facilitated a fundamental understanding of the systems kinetic trajectory and environmental sensitivities. This process insight enabling better process titre, reliability, scale-up (cell culture) and particle shape, size and control (crystallization) to be delivered across development and manufacturing scales.

These platforms importantly combine both scale (i.e. mixing) and kinetic (i.e. secondary nucleation, decreasing product titre) related effects to facilitate the development of manufacturing based strategies within a laboratory environment. The introduction of ‘virtual lab and plant’ aspects of these platforms will also be presented whereby the predictive nature of these tools aids process design for scale-up / scale-down and tech transfer.