Bioseparations and Downstream Processing

High-throughput methods for miniaturization and automation of monoclonal antibody purification processes

  1. Katrin Treier1,†,
  2. Sigrid Hansen1,
  3. Carolin Richter1,
  4. Patrick Diederich1,
  5. Jürgen Hubbuch1,*,
  6. Philip Lester2

Article first published online: 30 MAR 2012

DOI: 10.1002/btpr.1533

Issue

Biotechnology Progress

Biotechnology Progress

Volume 28, Issue 3, pages 723–732, May/June 2012

Additional Information

How to Cite

Treier, K., Hansen, S., Richter, C., Diederich, P., Hubbuch, J. and Lester, P. (2012), High-throughput methods for miniaturization and automation of monoclonal antibody purification processes. Biotechnol Progress, 28: 723–732. doi: 10.1002/btpr.1533

Author Information

  1. 1

    Section IV: Biomolecular Separation Engineering, Institute of Engineering in Life Sciences, Karlsruhe Institute of Technology, Engler-Bunte-Ring 1, Karlsruhe 76131, Germany

  2. 2

    Dept. of Early and Late Stage Purification, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080

  1. †

    BASF SE, Performance Biologicals, Ludwigshafen 67056, Germany

*Section IV: Biomolecular Separation Engineering, Institute of Engineering in Life Sciences, Karlsruhe Institute of Technology, Engler-Bunte-Ring 1, Karlsruhe 76131, Germany

Publication History

  1. Issue published online: 9 JUN 2012
  2. Article first published online: 30 MAR 2012
  3. Accepted manuscript online: 28 FEB 2012 08:36AM EST
  4. Manuscript Revised: 9 JAN 2012
  5. Manuscript Received: 5 AUG 2011

Funded by

  • Genentech, Inc.

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Keywords:

  • high-throughput screening;
  • packed bed chromatography;
  • monoclonal antibodies;
  • downstream process development;
  • miniaturization

Abstract

In the last decade, high-throughput downstream process development techniques have entered the biopharmaceutical industry. As chromatography is the standard downstream purification method, several high-throughput chromatographic methods have been developed and applied including miniaturized chromatographic columns for utilization on liquid handling stations. These columns were used to setup a complete downstream process on a liquid handling station for the first time. In this article, a monoclonal antibody process was established in lab-scale and miniaturized afterwards. The scale-down methodology is presented and discussed. Liquid handling in miniaturized single and multicolumn processes was improved and applicability was demonstrated by volume balances. The challenges of absorption measurement are discussed and strategies were shown to improve volume balances and mass balances in 96-well microtiter plates. The feasibility of miniaturizing a complete downstream process was shown. In the future, analytical bottlenecks should be addressed to gain the full benefit from miniaturized complete process development. © 2012 American Institute of Chemical Engineers Biotechnol. Prog., 2012

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