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Smart Process Analytics for the End-to-End Batch Manufacturing of Monoclonal Antibodies
  • +7
  • Richard Braatz,
  • Moo Sun Hong,
  • Fabian Mohr,
  • Chris D. Castro,
  • Benjamin T. Smith,
  • Jacqueline Wolfrum,
  • Stacy Springs,
  • Anthony Sinskey,
  • Roger A. Hart,
  • Tom Mistretta
Richard Braatz
Massachusetts Institute of Technology Department of Chemical Engineering

Corresponding Author:[email protected]

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Moo Sun Hong
Massachusetts Institute of Technology Department of Chemical Engineering
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Fabian Mohr
Massachusetts Institute of Technology Department of Chemical Engineering
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Chris D. Castro
Amgen Inc San Francisco
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Benjamin T. Smith
Amgen Inc San Francisco
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Jacqueline Wolfrum
Massachusetts Institute of Technology
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Stacy Springs
Massachusetts Institute of Technology
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Anthony Sinskey
Massachusetts Institute of Technology
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Roger A. Hart
Amgen Inc San Francisco
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Tom Mistretta
Amgen Inc San Francisco
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Abstract

For many modern biopharmaceutical processes, manufacturers develop data-driven models using data analytics/machine learning (DA/ML) methods. The challenge is how to select the best methods for a specific dataset to construct the most accurate and reliable model. This article describes the application of smart process data analytics software to industrial end-to-end biomanufacturing datasets for monoclonal antibody production to automate the determination of the best DA/ML tools for model construction and process understanding. The application demonstrates that smart process data analytics software captures product- and process-specific characteristics for two different monoclonal antibody productions. This study provides tools that can be widely applied to biomanufacturing processes for root cause analysis, prediction, and control.