Defining Process Design Space for a Multimodal Chromatography Purification Process
Posted on December 19, 2017
Jie Chen, Senior Scientist
Bristol-Myers Squibb
Na Zhang, Ronald Maurer, Xuankuo Xu, Sanchayita Ghose, Angela Lewandowski, Zhengjian Li
Abstract A process characterization study was performed to gain understanding of the multimodal chromatography (MMC) purification process and to map the design space. Six factors out of thirty-two process parameters were identified to be important by risk assessment. Two design of experiment methods...
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Related Topics and Keywords
Biological Development, Bristol-Myers Squibb, CD, chromatography, CPP, critical process parameter, custom design, definitive screening design, Design of Experiment, design of experiments, Design of Experiments (DoE), design space, DOE, Dr. Jie Chen, DSD, Failure Modes and Effects and Analysis, FMEA, full response-surface model, MMC, monoclonal antibody, multimodal chromatography, Multimodal Chromatography Purification Proces, Process characterization, purification process, QbD, Quality by Design, risk assessmen, RSM
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