Recent advances in integrated process analytical techniques, modeling, and control strategies to enable continuous biomanufacturing of monoclonal antibodies

Viki Chopda, Aron Gyorgypal, Ou Yang, Ravendra Singh, Rohit Ramachandran, Haoran Zhang, George Tsilomelekis, Shishir P.S. Chundawat, Marianthi G. Ierapetritou

Research output: Contribution to journalReview articlepeer-review

Abstract

Continuous bioprocessing is significantly changing the biological drugs (or biologics) manufacturing landscape by potentially improving product quality, process stability, and overall profitability, as was similarly seen during the adoption of advanced manufacturing processes for small molecule drugs in the past decade. However, the implementation of continuous manufacturing for biological processes producing protein-based drug molecules, such as monoclonal antibodies (mAbs), is facing several new hurdles. The barriers to continuous bioprocessing can be overcome through improved process understanding via better predictive capabilities enabled by hybrid modeling that can also lead to robust process control. This review article summarizes the recent advances and ongoing obstacles faced during the use of advanced process analytical technologies (PAT), process modeling, and control strategies to enable continuous manufacturing of mAbs. In addition, this review also discusses the process strategies and future directions of advanced continuous manufacturing approaches that have been adapted by other industries and that could be implemented for mAbs production soon.

Original languageEnglish (US)
JournalJournal of Chemical Technology and Biotechnology
DOIs
StateAccepted/In press - 2021

All Science Journal Classification (ASJC) codes

  • Pollution
  • Waste Management and Disposal
  • Chemical Engineering(all)
  • Biotechnology
  • Fuel Technology
  • Inorganic Chemistry
  • Renewable Energy, Sustainability and the Environment
  • Organic Chemistry

Keywords

  • biotechnology
  • industrial biotechnology
  • mathematical modelling
  • pharmaceuticals
  • process control
  • proteins

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