Online monitoring and control of upstream cell culture process using 1D and 2D-LC with SegFlow interface.

Autor: Chemmalil L; BMS Process Development Analytical Group, Devens, Massachusetts, USA., Wasalathanthri DP; BMS Process Development Analytical Group, Devens, Massachusetts, USA., Zhang X; BMS Analytical Development & Analytical Attribute Science in Biologics, Devens, Massachusetts, USA., Kuang J; BMS Analytical Development & Analytical Attribute Science in Biologics, Devens, Massachusetts, USA., Shao C; BMS Process Development Analytical Group, Devens, Massachusetts, USA., Barbour R; University of Rochester, Rochester, New York, USA., Bhavsar S; BMS Analytical Development & Analytical Attribute Science in Biologics, Devens, Massachusetts, USA., Prabhakar T; BMS Manufacturing Science & Technology, Devens, Massachusetts, USA., Knihtila R; Dragonfly Therapeutics, Waltham, Massachusetts, USA., West J; BMS Process Development Analytical Group, Devens, Massachusetts, USA., Puri N; BMS Process Development Analytical Group, Devens, Massachusetts, USA., McHugh K; BMS Process Development Group, Devens, Massachusetts, USA., Rehmann MS; BMS Process Development Group, Devens, Massachusetts, USA., He Q; BMS Process Development Group, Devens, Massachusetts, USA., Xu J; BMS Process Development Group, Devens, Massachusetts, USA., Borys MC; BMS Process Development Group, Devens, Massachusetts, USA., Ding J; BMS Process Development Analytical Group, Devens, Massachusetts, USA., Li Z; BMS Analytical Development & Analytical Attribute Science in Biologics, Devens, Massachusetts, USA.
Jazyk: angličtina
Zdroj: Biotechnology and bioengineering [Biotechnol Bioeng] 2021 Sep; Vol. 118 (9), pp. 3593-3603. Date of Electronic Publication: 2021 Jul 12.
DOI: 10.1002/bit.27873
Abstrakt: The biopharmaceutical industry is transitioning from currently deployed batch-mode bioprocessing to a highly efficient and agile next-generation bioprocessing with the adaptation of continuous bioprocessing, which reduces capital investment and operational costs. Continuous bioprocessing, aligned with FDA's quality-by-design platform, is designed to develop robust processes to deliver safe and effective drugs. With the deployment of knowledge-based operations, product quality can be built into the process to achieve desired critical quality attributes (CQAs) with reduced variability. To facilitate next-generation continuous bioprocessing, it is essential to embrace a fundamental shift-in-paradigm from "quality-by-testing" to "quality-by-design," which requires the deployment of process analytical technologies (PAT). With the adaptation of PAT, a systematic approach of process and product understanding and timely process control are feasible. Deployment of PAT tools for real-time monitoring of CQAs and feedback control is critical for continuous bioprocessing. Given the current deficiency in PAT tools to support continuous bioprocessing, we have integrated Infinity 2D-LC with a post-flow-splitter in conjunction with the SegFlow autosampler to the bioreactors. With this integrated system, we have established a platform for online measurements of titer and CQAs of monoclonal antibodies as well as amino acid analysis of bioreactor cell culture.
(© 2021 Wiley Periodicals LLC.)
Databáze: MEDLINE
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