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Virus clearance validation across continuous capture chromatography.

James Angelo1, Srinivas Chollangi1, Thomas Müller-Späth2

  • 1Biologics Process Development, Bristol-Myers Squibb, Inc, Devens, Massachusetts.

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|May 8, 2019
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Summary
This summary is machine-generated.

Continuous chromatography offers economic advantages but needs scalable viral validation. This study shows twin-column continuous capture chromatography (CaptureSMB) and a batch surrogate model achieve comparable virus clearance, supporting its clinical adoption.

Keywords:
MVMX-MuLVcontinuous chromatographyprotein Aviral carryoverviral clearance

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Area of Science:

  • Biotechnology
  • Process Chemistry
  • Viral Clearance Studies

Background:

  • Multicolumn continuous chromatography offers significant economic and process advantages over traditional batch methods.
  • Scalable models for viral validation are crucial for the widespread adoption of continuous chromatography in clinical and commercial settings.
  • Existing viral validation models may not fully represent the complexities of continuous chromatography systems.

Purpose of the Study:

  • To assess retro- (X-MuLV) and parvo-virus (MVM) clearance using twin-column continuous capture chromatography (CaptureSMB) under cGLP guidelines.
  • To develop and validate a surrogate model using batch chromatography to mimic CaptureSMB loading strategies for viral clearance.
  • To evaluate the impact of resin cleaning strategies and clean-in-place (CIP) solution exposure duration on virus carryover in continuous chromatography.

Main Methods:

  • Viral validation studies were performed using X-MuLV and MVM with twin-column CaptureSMB under current Good Laboratory Practice (cGLP) conditions.
  • A surrogate model was developed using standard batch chromatography, modifying flow paths to replicate the CaptureSMB loading strategy.
  • Resin cleaning strategies and CIP exposure times were assessed for their effect on virus clearance and carryover.

Main Results:

  • Steady-state conditions for both antibody binding and virus clearance were achieved by the second cycle in CaptureSMB.
  • The batch surrogate model demonstrated impurity clearance comparable to the cyclical operation of CaptureSMB.
  • Log reduction values (LRVs) from CaptureSMB were comparable to those from standard batch chromatography, consistent with virus removal during flow-through and wash steps.
  • Assessments on resin cleaning revealed the impact of CIP solution exposure duration on virus carryover.

Conclusions:

  • Continuous capture chromatography, specifically CaptureSMB, provides effective viral clearance comparable to traditional batch methods.
  • The developed batch surrogate model is a viable tool for predicting viral clearance in continuous chromatography systems.
  • Optimized resin cleaning strategies are essential to prevent virus carryover in continuous chromatography processes, supporting its use in biopharmaceutical manufacturing.