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Continuous Solvent/Detergent Virus Inactivation Using a Packed-Bed Reactor.

Duarte L Martins1,2, Jure Sencar1,2, Nikolaus Hammerschmidt1,2

  • 1Austria Centre for Industrial Biotechnology, Vienna, Austria.

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Summary

Continuous virus inactivation (VI) is now achievable in biopharma manufacturing using a novel reactor. This system ensures effective viral clearance with a narrow residence time distribution, matching batch process results.

Keywords:
bovine viral diarrhea virusmurine leukemia virusresidence time distributiontri-n-butyl phosphatevirus clearance

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Process Engineering
  • Viral Safety

Background:

  • Continuous manufacturing is advancing in the biopharma industry, but continuous virus inactivation (VI) remains a significant challenge.
  • Key hurdles for continuous VI include achieving fluid homogeneity and a narrow residence time distribution (RTD).

Purpose of the Study:

  • To develop and validate a continuous virus inactivation (VI) process suitable for biopharmaceutical manufacturing.
  • To address the challenges of fluid homogeneity and narrow RTD in continuous VI systems.

Main Methods:

  • Implementation of a dynamic active in-line mixer for homogeneous S/D chemical mixing.
  • Utilization of a packed-bed continuous virus inactivation reactor (CVIR) for narrow RTD incubation.
  • Characterization of mixer performance and reactor RTD using model viruses and solvent/detergent (S/D) treatment.

Main Results:

  • The in-line mixer achieved ±1.0% target concentration accuracy for viscous S/D chemicals in minimal dead volume.
  • The CVIR demonstrated rapid steady-state achievement and viral log reduction values comparable to traditional batch processing.
  • Control experiments confirmed S/D action as the primary mechanism for virus inactivation.

Conclusions:

  • A novel packed-bed reactor system enables continuous virus inactivation with excellent mixing and narrow RTD.
  • The developed continuous VI process is scalable, exhibits low pressure drop, and achieves viral clearance equivalent to batch methods.
  • This technology represents a crucial advancement for fully continuous biopharmaceutical manufacturing.