Bioseparations and Downstream Processing

Expression and purification of cGMP grade NY-ESO-1 for clinical trials

  1. Adam J. Lowe1,*,
  2. Cameron L. Bardliving2,
  3. Chung-Jr Huang1,†,
  4. Leonardo M. Teixeira1,‡,
  5. Leonardo M. Damasceno1,§,
  6. Kyle A. Anderson1,¶,
  7. Gerd Ritter3,
  8. Lloyd J. Old3,
  9. Carl A. Batt4

Article first published online: 1 MAR 2011

DOI: 10.1002/btpr.552

Issue

Biotechnology Progress

Biotechnology Progress

Volume 27, Issue 2, pages 435–441, March/April 2011

Additional Information

How to Cite

Lowe, A. J., Bardliving, C. L., Huang, C.-J., Teixeira, L. M., Damasceno, L. M., Anderson, K. A., Ritter, G., Old, L. J. and Batt, C. A. (2011), Expression and purification of cGMP grade NY-ESO-1 for clinical trials. Biotechnol Progress, 27: 435–441. doi: 10.1002/btpr.552

Author Information

  1. 1

    Graduate Field of Microbiology, Cornell University, Ithaca, NY 14853

  2. 2

    Graduate Field of Biomedical Engineering, Cornell University, Ithaca, NY 14853

  3. 3

    LICR – NY Branch, Memorial Sloan Kettering, New York, NY 10021

  4. 4

    Department of Food Science, Cornell University, Ithaca, NY 14853

  1. Tetragenetics, Inc., Ithaca, NY 14850

  2. †

    DeLisa Laboratory, Department of Chemical Engineering, Cornell University. Ithaca, NY 14853

  3. ‡

    Graduate School, Faculdade de Tecnologia e Ciências, Salvador, Brazil

  4. §

    Graduate School, Faculdade de Technologia e Ciencias, Salvador, Brazil

*Graduate Field of Microbiology, Cornell University, Ithaca, NY 14853

Publication History

  1. Issue published online: 11 APR 2011
  2. Article first published online: 1 MAR 2011
  3. Accepted manuscript online: 8 DEC 2010 01:45PM EST
  4. Manuscript Revised: 21 NOV 2010
  5. Manuscript Received: 22 JUL 2010

Funded by

  • Cancer Research Institute
  • Ludwig Institute for Cancer Research

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Keywords:

  • NY-ESO-1;
  • purification;
  • CT-antigen;
  • vaccine;
  • cancer

Abstract

NY-ESO-1 is a cancer testis antigen expressed in numerous cancers. Initial tests have shown its efficacy as a cancer vaccine, stimulating the body's own immune response against the invading tumor. To produce enough material for phase I clinical trials, a process using current good manufacturing practices to produce clinical grade material was developed and executed. His-tagged NY-ESO-1 was expressed in C41DE3 Escherichia coli under control of the T-7 promoter. NY-ESO-1 was produced in a 20 L fed-batch fermentation utilizing a pH-stat control scheme. The protein was then purified from inclusion bodies using a three-column process that achieved a yield of over 3.4 g and endotoxin below the detection limit of 0.005 EU/μg protein. © 2011 American Institute of Chemical Engineers Biotechnol. Prog., 2011

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