Model Predictive Control for automated biologics drug product manufacturing скачать в хорошем качестве

Model Predictive Control for automated biologics drug product manufacturing

The presentation will focus on the development, testing, and justification of an advanced control strategy for automating the dilution process during the formulation step in fill-finish manufacturing. The proposed control strategy is founded on precise, accurate and fast protein concentration measurements, all provided by the FlowVPE technology. Being able to rely on timely, high-quality concentration measurements, the novel strategy combines the FlowVPE implemented in-line with real-time data processing and modeling, to achieve immediate feedback control of the dilution process without the need for human intervention. This approach was developed and tested in a lab-scale representative setup. In all performed tests, the automated process reached the target protein concentration with high accuracy and precision despite process variations and irregularities. The proposed automated dilution allows for increased productivity and offers a strategy with wide applicability. About the Speaker: Renata Pocitarenco is an Associate Scientist at Janssen, Switzerland. She received a B.Sc. and a M.Sc. in Chemical and Process Engineering from University of Padova, Italy, in 2019 and 2021 respectively focusing on process systems engineering, chemometric and statistical modeling. Marius Mueller is leading the analytical fill-finish support team at Janssen, Schaffhausen, Switzerland. His team is responsible for analytical study support as well as scouting, development and implementation of new PAT tools for drug product manufacturing.