Article

Monoclonal antibody capture and viral clearance by cation exchange chromatography†

  1. G.R. Miesegaes1,
  2. S. Lute1,
  3. D.M. Strauss2,
  4. E.K. Read1,
  5. A. Venkiteshwaran2,
  6. A. Kreuzman2,
  7. R. Shah3,
  8. P. Shamlou2,
  9. D. Chen2,
  10. K. Brorson1,*

Article first published online: 8 APR 2012

DOI: 10.1002/bit.24480

Issue

Biotechnology and Bioengineering

Biotechnology and Bioengineering

Volume 109, Issue 8, pages 2048–2058, August 2012

Additional Information

How to Cite

Miesegaes, G.R., Lute, S., Strauss, D.M., Read, E.K., Venkiteshwaran, A., Kreuzman, A., Shah, R., Shamlou, P., Chen, D. and Brorson, K. (2012), Monoclonal antibody capture and viral clearance by cation exchange chromatography. Biotechnol. Bioeng., 109: 2048–2058. doi: 10.1002/bit.24480

Author Information

  1. 1

    Office of Biotechnology Products, CDER/FDA, 10903 New Hampshire Ave., Silver Spring, Maryland 20903; telephone: 301-796-2095; fax: 301-796-9817

  2. 2

    Eli Lilly and Company, Indianapolis, Indiana

  3. 3

    Office of Testing and Research, CDER/FDA, Silver Spring, Maryland

*Office of Biotechnology Products, CDER/FDA, 10903 New Hampshire Ave., Silver Spring, Maryland 20903; telephone: 301-796-2095; fax: 301-796-9817.

  1. †

    Conclusions in this manuscript are those of the authors and do not necessarily represent official policy of the Food and Drug Administration. The FDA does not recommend or endorse specific chromatography resins.

Publication History

  1. Issue published online: 18 JUN 2012
  2. Article first published online: 8 APR 2012
  3. Accepted manuscript online: 1 MAR 2012 09:01AM EST
  4. Manuscript Accepted: 16 FEB 2012
  5. Manuscript Revised: 10 FEB 2012
  6. Manuscript Received: 6 SEP 2011

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Keywords:

  • monoclonal antibodies;
  • viral clearance;
  • cation exchange chromatography

Abstract

Traditionally, post-production culture harvest capture of therapeutic monoclonal antibodies (mAbs) is performed using Protein A chromatography. We investigated the efficiency and robustness of cation exchange chromatography (CEX) in an effort to evaluate alternative capture methodologies. Up to five commercially available CEX resins were systematically evaluated using an experimentally optimized buffer platform and a design-of-experiment (DoE) approach for their ability to (a) capture a model mAb with a neutral isoelectric point, (b) clear three model viruses (porcine parvovirus, CHO type-C particles, and a bacteriophage). This approach identified a narrow operating space where yield, purity, and viral clearance were optimal under a CEX capture platform, and revealed trends between viral clearance of PPV and product purity (but not yield). Our results suggest that after unit operation optimization, CEX can serve as a suitable capture step. Biotechnol. Bioeng. 2012; 109:2048–2058. © 2012 Wiley Periodicals, Inc.

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