Chapter 13. Development of Validated Neutralization Bioassays

  1. Uma Prabhakar Ph.D. and
  2. Marian Kelley Director of Compliance
  1. Manoj Rajadhyaksha,
  2. Manjula Reddy,
  3. Jaime Bald,
  4. Amy Fraunfelter,
  5. Persymphonie Miller,
  6. Marian Kelley Director of Compliance and
  7. Uma Prabhakar Ph.D.

Published Online: 8 APR 2008

DOI: 10.1002/9780470987810.ch13

Validation of Cell-Based Assays in the GLP Setting: A Practical Guide

Validation of Cell-Based Assays in the GLP Setting: A Practical Guide

How to Cite

Rajadhyaksha, M., Reddy, M., Bald, J., Fraunfelter, A., Miller, P., Kelley, M. and Prabhakar, U. (2008) Development of Validated Neutralization Bioassays, in Validation of Cell-Based Assays in the GLP Setting: A Practical Guide (eds U. Prabhakar and M. Kelley), John Wiley & Sons, Ltd, Chichester, UK. doi: 10.1002/9780470987810.ch13

Editor Information

  1. Department of Clinical Pharmacology & Experimental Medicine, Centocor Research and Development, Inc., 145 King of Prussia Road, Radnor, PA 19087, USA

Author Information

  1. Department of Clinical Pharmacology & Experimental Medicine, Centocor Research and Development, Inc., 145 King of Prussia Road, Radnor, PA 19087, USA

Publication History

  1. Published Online: 8 APR 2008
  2. Published Print: 21 MAR 2008

ISBN Information

Print ISBN: 9780470028766

Online ISBN: 9780470987810

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Keywords:

  • neutralizing antibodies;
  • anti-drug-antibodies;
  • functional;
  • cellular;
  • bioassays

Summary

This chapter contains sections titled:

  • Introduction

  • NAb Assay Development

  • Anti-DRUG Y neutralization bioassay development and validation

  • Anti-DRUG Y NAb assay procedure

  • Development and validation of IFN-γ ELISA

  • Development and validation of IFN-γ induction assay

  • NAb bioassay robustness

  • Result output, interpretation, assay/plate and data acceptance criteria for clinical samples

  • Summarizing remarks

  • References