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More Accurate Process Understanding From Process Characterization Studies Using Monte Carlo Simulation, Regularized Regression, And Classification Models, Cary Opel, Cerintha J. Hui, Patrick Y. Yang, Daniel J. Tien, Gayle E. Derfus, Rajesh Krishnan
More Accurate Process Understanding From Process Characterization Studies Using Monte Carlo Simulation, Regularized Regression, And Classification Models, Cary Opel, Cerintha J. Hui, Patrick Y. Yang, Daniel J. Tien, Gayle E. Derfus, Rajesh Krishnan
Cell Culture Engineering XVI
Establishment of an appropriate control strategy with defined operating ranges (OR) predicted to meet a target product profile is a critical component of commercializing new biologics under the Quality by Design (QbD) approach. Process characterization (PC) studies are performed to expand process understanding by achieving two main goals: 1) determining which process parameters have significant effects on quality attributes and 2) establishing models describing the relationships between these critical process parameters (CPP) and critical quality attributes (CQA). Risk assessment and design of experiments (DOE) techniques are effectively deployed in the industry to identify parameters to study and build process understanding. …