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Online/at-line measurement,analysis and control of product titer and critical product quality attributes (CQAs) during process development
Authors:Letha Chemmalil  Tanushree Prabhakar  June Kuang  Jay West  Zhijun Tan  Vivekh Ehamparanathan  Yuanli Song  Jianlin Xu  Julia Ding  Zhengjian Li
Affiliation:1. BMS Analytical Method Development Group, Devens, Massachusetts;2. BMS Manufacturing Science & Technology, Devens, Massachusetts;3. BMS Process Analytical Group, Devens, Massachusetts;4. BMS Process Development Group, Devens, Massachusetts
Abstract:
Keywords:continuous processing  HPLC  monoclonal antibody  process analytical technology  quality by design  UV/Vis spectroscopy
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