Chromatography Based Near-Real-Time Measurements & Timely Control...

Presented by

Letha Chemmalil, at BMS, Magnus Wetterhall and Nick Pittman at Waters

About this talk

Full title: Chromatography Based Near-Real-Time Measurements & Timely Control of Product Titer, Product Quality and Cell Culture Nutrients PAT has been defined by the FDA as a system for designing, analyzing, and controlling the manufacturing through timely measurements of CQAs to ensure desired final product quality. Based on the QbD principles, online data monitoring is essential for timely control of CPPs and CQAs to keep the process in a state of control. To facilitate next-generation continuous bioprocessing, deployment of PAT tools for real-time monitoring is essential for process understanding and control to keep the process within the design space to align with the guiding principles of QbD. Highlight of this presentation is pertaining to the emerging PAT tools we developed for monitoring online upstream titer and nutrients as well as upstream and downstream product quality with the option to perform timely process control. For the measurement of titer from bioreactors and CQAs from downstream unit operations, 1D-LC system interfaced with a process sample manager is utilized. A 2D-LC/1D-LC system interfaced with an inline sampling device is used for various applications including online measurements of product titer, product quality and online amino acid quantitation bioreactor samples. A µSIA system interfaced with a sampling device and 1D-LC is being leveraged for comlex analyses requiring extensive sample preparations.
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