(342d) Controlled Protein Capture Via Continuous Precipitation for Downstream Processing in Monoclonal Antibody Manufacturing
AIChE Annual Meeting
2023
2023 AIChE Annual Meeting
Food, Pharmaceutical & Bioengineering Division
Novel Process Technologies in Food and Biomanufacturing
Wednesday, November 8, 2023 - 8:54am to 9:12am
For Pharma 4.0 purposes, process automation and control play critical roles in the transformation from batch to continuous processing. Hence, using system identification techniques we developed data-driven models to design a Proportional-Integral controller with sample time of 1 minute. Two BlazeMetrics statistics were selected based on validation fits as the desired controlled variable while the PEG flowrate was selected as the manipulated variable.
Furthermore, to bring a biological-based therapeutic to market quickly it is important to use Smart Manufacturing (Industry 4.0) techniques to integrate data, model predictions, and closed-loop real-time automation to move from bench to pilot-plant to full scale manufacturing in a short period of time. This was enabled for the bench scale system by the Smart Manufacturing Innovation Platform developed by the Clean Energy Smart Manufacturing Innovation Institute. The integrated operations, including hardware, software, algorithms, and cloud platforms demonstrate a first-of-kind continuous downstream technology using precipitation and filtration for next generation Pharma 4.0 processing.
Keywords: Pharma 4.0, Smart manufacturing (SM), Monoclonal Antibodies (mAbs), Process Control, Downstream Process, Precipitation, Simulation, Modeling.