In this webinar, we explore the advancement from traditional open-loop control strategies in biomufacturing to automated feedback control for managing protein characteristics in a perfusing bioprocess. Traditionally, critical process parameters are maintained within set ranges to ensure product consistency, but this method often fails to adapt to unexpected process disturbances. The integration of advanced process technologies, exemplified by the shift from manual to automated glucose measurement, illustrates how real-time data can significantly enhance process stability and product quality. However, challenges remain, notably in integrating mass spectrometry effectively into the bioproduction environment. This shift necessitates overcoming hurdles related to software integration, data management, and the robustness of hardware systems within a production setting.

To address these challenges, our focus has shifted towards developing suitable methods for process integration, constructing a prototype production system with a feedback control loop, and devising a bi-directional process that leverages this integrated data. Method development specifically targets enhancing the controllability of glycosylation states—key protein characteristics—using mass spectrometry, which despite its precision, presents difficulties in standardization across different systems. The intricate process of integrating these systems into a feedback loop involves not only precise analytical techniques but also robust mechanical systems to handle automated, sterile sampling and data processing. This initiative moves towards a more controlled bioproduction environment, where continuous real-time measurements can directly influence and stabilize production processes, marking a significant step forward in the biomanufacturing sector.