QbD webinar: Digital Twins and PAT for process control of Inclusion Body refolding

October 21, 2020

In this webinar, organised by the EFCE Working Party, our innovative project aiming to provide solutions for the challenges faced in the highly complex downstream processing of bacterial Inclusion Bodies (IBs) will be introduced. The refolding step is one of the most critical and yet most poorly understood phases of the IB purification process chain in terms of product quality and overall yield, as until now, mainly empirical and hardly scalable methods are applied, generally resulting in low final product yields.

Thus, there is an urgent need for generic platform procedures and robust control strategies for refolding. Process understanding generated according to Quality by Design principles could serve as a basis for a controlled, reproducible and economically viable refolding solution. Therefore, we propose a combined approach of advanced Process Analytical Technology and process monitoring using Digital Twins, which are both implemented in the control software Qubicon® by Bilfinger Industrietechnik Salzburg. According to this concept, all aspects of a refolding process will be definable either via direct monitoring or Digital Twin-based estimation. Ultimately, this paves the way for real-time process control and increased final product yields.