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Understanding virus retention mechanisms on protein a chromatography based on using different wash buffers - Evaluating the possibility for a generic wash buffer toolbox to improve virus clearance capacity.

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Mimicking continuous capture chromatography for virus clearance using a single chromatography column model.

Florian Capito1, Hendrik Flato1, Verena Oeinck1

  • 1Purification Process Development, Industriepark Höchst, Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany.

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|January 28, 2022
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Summary

A simplified single-column model effectively mimics continuous chromatography for virus clearance studies. This approach reduces complexity and resource needs for biotechnology manufacturing, validating continuous chromatography adoption.

Keywords:
BioSMBcontinuous capture chromatographyprotein Avirus clearance

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Area of Science:

  • Biotechnology
  • Biopharmaceutical Manufacturing
  • Chromatography

Background:

  • Continuous chromatography offers economic benefits for biotechnology but requires validated virus clearance models for commercial manufacturing.
  • Existing models for continuous chromatography virus clearance are complex and resource-intensive.
  • Multispecific antibody production necessitates robust virus clearance strategies.

Purpose of the Study:

  • To develop and validate a simplified, small-scale model for virus clearance studies in continuous protein A capture chromatography.
  • To assess the feasibility of using a single-column model to mimic multi-column continuous chromatography processes.
  • To evaluate the economic and resource advantages of the simplified model for contract research organization (CRO) labs.

Main Methods:

  • A single-column chromatography system was used to mimic a multi-column continuous protein A capture process.
  • Virus clearance studies were performed using model viruses: murine leukemia virus (xMuLV) and minute virus of mice (MVM).
  • Log reduction values (LRV) were determined and compared to traditional batch chromatography and literature data.

Main Results:

  • The single-column model successfully mimicked the continuous chromatography process for virus clearance.
  • Obtained LRV for xMuLV and MVM were comparable to batch protein A chromatography.
  • Results align with previously published data on virus clearance using protein A chromatography.

Conclusions:

  • A simplified small-scale model using a single column is feasible for virus clearance studies in continuous chromatography.
  • This model reduces complexity and resource requirements, facilitating the adoption of continuous chromatography in biopharmaceutical manufacturing.
  • The validated model supports the implementation of continuous chromatography by addressing the need for efficient virus clearance studies.