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Model-based control for column-based continuous viral inactivation of biopharmaceuticals.

Moo Sun Hong1, Amos E Lu1, Rui Wen Ou2

  • 1Department of Chemical Engineering, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.

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|June 8, 2021
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This study presents a novel, low-cost continuous viral inactivation system for biopharmaceutical manufacturing. It effectively controls pH and residence time, ensuring consistent viral reduction for improved product quality and patient safety.

Keywords:
bioprocess engineeringcontinuous processingviral inactivation

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Process Engineering
  • Viral Safety

Background:

  • Batch low-pH hold is a standard method for viral inactivation in biologics.
  • Transitioning to continuous biopharmaceutical manufacturing requires adapting viral inactivation steps.
  • Control challenges in continuous viral inactivation systems have been a significant hurdle.

Purpose of the Study:

  • To develop and validate a low-cost, column-based continuous viral inactivation system.
  • To implement advanced control strategies for pH and residence time.
  • To address the control challenges in continuous viral inactivation processes.

Main Methods:

  • Construction of a continuous system using off-the-shelf components.
  • Implementation of a model-based, reaction-invariant pH controller with Bayesian estimation.
  • Modeling residence time distribution using plug flow reactor with axial dispersion in series with a CSTR, estimated via inverse tracer experiments.

Main Results:

  • Successful demonstration of pH and minimum residence time setpoint tracking and disturbance rejection.
  • Achieved fast, accurate responses with no instability during controller validation.
  • Consistent viral inactivation, evidenced by tight control of logarithmic reduction values over extended operation.

Conclusions:

  • The developed system provides a viable solution for continuous viral inactivation.
  • The control strategies ensure robust performance and consistent viral reduction.
  • This work offers tools to enhance biopharmaceutical manufacturing productivity, quality, and patient safety.