Bridging the gap between PAT concepts and implementation: An integrated software platform for fermentation.

Abstract

Bioreactor control significantly impacts both the amount and quality of the product being manufactured. The complexity of the control strategy that is implemented increases with reactor size, which may vary from thousands to tens of thousands of litres in commercial manufacturing. The Process Analytical Technology (PAT) initiative has highlighted the need for having robust monitoring tools and effective control schemes that are capable of taking real time information about the critical quality attributes (CQA) and the critical process parameters (CPP) and executing immediate response as soon as a deviation occurs. However, the limited flexibility that present commercial software packages offer creates a hurdle. Visual programming environments have gradually emerged as potential alternatives to the available text based languages. This paper showcases development of an integrated programme using a visual programming environment for a Sartorius BIOSTAT® B Plus 5L bioreactor through which various peripheral devices are interfaced. The proposed programme facilitates real-time access to data and allows for execution of control actions to follow the desired trajectory. Major benefits of such integrated software system include: (i) improved real time monitoring and control; (ii) reduced variability; (iii) improved performance; (iv) reduced operator-training time; (v) enhanced knowledge management; and (vi) easier PAT implementation.