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Lab-Scale Continuous Biomanufacturing: A Tool for Process Development With Adaptive Strategies for Capture and Virus

Thomas Kruse1, Fabian Schmitz1, Janina Kilian1

  • 1Sartorius, Corporate Research, Göttingen, Germany.

Biotechnology and Bioengineering
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Summary
This summary is machine-generated.

This study presents an integrated continuous biomanufacturing process for monoclonal antibodies (mAbs). The novel lab-scale process achieves high yield and impurity removal, demonstrating its potential for process development.

Keywords:
PATadvanced control strategiesbiolayer interferometrycontinuous virus inactivationintegrated continuous biomanufacturingmAbsimulated moving bed chromatography

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Area of Science:

  • Biotechnology and Bioprocessing
  • Pharmaceutical Manufacturing
  • Process Intensification

Background:

  • Monoclonal antibodies (mAbs) are crucial therapeutics for various diseases.
  • The growing mAb market necessitates advanced process intensification technologies.
  • Current biomanufacturing often relies on batch processes, limiting throughput.

Purpose of the Study:

  • To introduce and evaluate a novel lab-scale integrated continuous biomanufacturing (ICB) process.
  • To demonstrate adaptive control strategies for process variations.
  • To assess the efficiency of continuous downstream processing for mAbs.

Main Methods:

  • Development of a lab-scale ICB process combining perfusion upstream cultivation and continuous downstream processing.
  • Utilized membrane adsorbers (RC-BioSMB) for continuous chromatography capture.
  • Implemented a novel continuous virus inactivation (VI) approach.
  • Operated the process continuously for 4 days with adaptive flow rate control.

Main Results:

  • Achieved a high overall yield of 88% during the 4-day continuous operation.
  • Demonstrated effective removal of host cell proteins (3.4 log) and DNA (2.9 log).
  • Successfully adapted flow rates to address upstream process variations (titer, permeate flow rate).

Conclusions:

  • The lab-scale ICB process is a viable tool for process development and intensification.
  • Continuous downstream processing with adaptive control ensures consistent mAb purification.
  • The developed ICB process offers high yield and significant impurity reduction for mAb production.