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Our research area is in line with Process Analytical Technology (PAT), an US FDA initiative emphasizing “Building Quality into Products with Innovative Process Design.” PAT is an emerging area of research with the biopharmaceutical industry employing it at different stages such as raw material characterization, in-process monitoring, and final product analysis. Due to the complex and nonlinear characteristics of any bioprocess, monitoring, measuring, modelling, and controlling (M3C) are critical in bioprocess development. Regulatory authorities such as FDA, EMA, and ICH have manifested their interest in M3C methodology in their guidance documents and regulations.

We, as a crew, study the robust manufacturing of bio-therapeutics, biopolymers, and nutraceuticals. Based on the notion of revamping the microbial cells as factories by manipulating their metabolic pathway, optimizing the process conditions, real-time monitoring, and controlling the critical process parameters (CPPs) to boost productivity and achieve consistent product quality. In our BioPAT lab facility, bioprocess development of a product is facilitated via M3C technique. Employing PAT tools such as fermentation calorimeter, dielectric spectroscopy, exhaust gas analyzer, and optical density probe provides real-time metabolic insights into a bioprocess. These tools aid in identifying critical process parameters of the processes. Combining real-time measurements obtained from PAT tools with robust control strategies such as inferential control, adaptive control, model predictive control, and data-driven control ensures a consistent quality of the final product.