Process Analytical Technology for Upstream Bioprocessing
Posted on November 13, 2025
Erica J. Fratz-Berilla, Staff Fellow, FDA/CDER/OPQ/OBP/DBRRII
Cyrus D. Agarabi, Associate Director, (Previously Regulatory Research Officer and
Principal Investigator), CAPT – CDER/OPQ/IO
Summary In commercial cell culture bioprocessing, consistent high quality protein is a fundamental goal that is typically accomplished during development through product and process engineering of bioreactor parameters. The FDA’s Center for Drug Evaluation and Research (CDER)’s Office of Biotech...
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Related Topics and Keywords
bioassays, bioreactor cell culture, CDER, Center for Drug Evaluation and Research, Center of Excellence, COE, continuous bioreactor cell culture production, CQAs, critical quality attributes, culture bioprocessing, Cyrus Agarabi, Erica Fratz-Berilla, FDA, FDA CDER’s Office, glycosylated proteins, high performance liquid chromatography, HPLC, mAb, mass spectrometry, monoclonal antibodies, MS, Office of Biotechnology, PAT, Process Analytical Technology, therapeutic monoclonal antibody, upstream bioprocessing
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