Abstract
Online monitoring of critical quality attributes (CQAs) directly within the bioreactor can provide the basis for advanced processing of therapeutics production, including automated real-time monitoring, feedback control process intensification, smart manufacturing, and real-time release testing. This paper presents recent developments in online high performance liquid chromatography–high-resolution mass spectrometry (HPLC–HRMS) platforms as a promising process analytical technology (PAT) tool for real-time monitoring of antibody quality attributes (QAs) in biopharmaceutical processes. This technology can be used to monitor multiple CQAs and process parameters during cell culture production, enabling real-time decisions.
Publisher
Multimedia Pharma Sciences, LLC
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