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Using a noninfectious MVM surrogate for assessing viral clearance during downstream process development.

Joshua D Orchard1, David Cetlin2, Melanie Pallansch3

  • 1MedImmune, Gaithersburg, Maryland.

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|October 7, 2019
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Summary

Using a noninfectious minute virus of mice-mock virus particle (MVM-MVP) as a surrogate for live viruses, this study demonstrates effective viral clearance during biopharmaceutical manufacturing. This approach simplifies viral clearance studies for filtration and chromatography, reducing costs and complexity.

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Process Development
  • Viral Clearance

Background:

  • Viral contamination poses a significant risk in biopharmaceutical production.
  • Demonstrating viral clearance efficacy is mandatory for regulatory approval.
  • Current methods using live viruses are costly and logistically difficult.

Purpose of the Study:

  • To evaluate a noninfectious surrogate, minute virus of mice-mock virus particle (MVM-MVP), for viral clearance studies.
  • To assess the efficacy of viral filtration (VF) and anion exchange chromatography (AEX) using MVM-MVP.
  • To simplify and reduce the cost of viral clearance assessments during process development.

Main Methods:

  • Small-scale viral filtration (VF) and anion exchange chromatography (AEX) studies were performed.
  • Minute virus of mice-mock virus particle (MVM-MVP) was used as a surrogate spiking agent.
  • Experiments involved various nanofilters and chromatography conditions (sodium chloride gradients).

Main Results:

  • Flux decay profiles and log reduction values (LRVs) were similar between MVM-MVP and live viruses across different nanofilters.
  • AEX experiments with MVM-MVP accurately predicted viral removal.
  • MVM-MVP proved to be a reliable surrogate for assessing viral clearance.

Conclusions:

  • Minute virus of mice-mock virus particle (MVM-MVP) is an effective noninfectious surrogate for viral clearance studies in biopharmaceutical manufacturing.
  • This surrogate simplifies viral clearance assessments for VF and AEX processes.
  • The use of MVM-MVP can reduce the cost and complexity of process development and characterization.