Journal
BIOTECHNOLOGY AND BIOENGINEERING
Volume 118, Issue 9, Pages 3593-3603Publisher
WILEY
DOI: 10.1002/bit.27873
Keywords
2D-LC; continuous bioprocessing; monoclonal antibody (mAb); process analytical technology (PAT); quality by design (QbD); SegFlow
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The biopharmaceutical industry is shifting towards continuous bioprocessing to reduce costs and improve efficiency, with the support of process analytical technologies (PAT). Knowledge-based operations can integrate product quality into processes to achieve desired critical quality attributes and reduce variability.
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.
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