Chapter 3. Development, Optimization and Validation of Cell-Based Assays – 2

  1. Uma Prabhakar Ph.D. and
  2. Marian Kelley Director of Compliance
  1. Manjula Reddy and
  2. Uma Prabhakar Ph.D.

Published Online: 8 APR 2008

DOI: 10.1002/9780470987810.ch3

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

Reddy, M. and Prabhakar, U. (2008) Development, Optimization and Validation of Cell-Based Assays – 2, 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.ch3

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

  1. To whom correspondence should be addressed.

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:

  • peripheral blood mononuclear cells (PBMCs);
  • validation, stability, and stimulation

Summary

There is increasing interest in the use of cell-based in vitro assays to monitor immune function in drug development and to study the treatment effect in a clinical study. Since the results of such tests are used to monitor safety, the testing laboratory is required to perform sample analysis using validated assays that are reliable, specific, reproducible and robust with acceptable precision. In this chapter, we will provide reference guidelines for the development and validation of immunoassays used to evaluate cellular immune responses using peripheral blood mononuclear cells. The chapter includes specific recommendations for addressing various validation parameters along with clinical implementation of the validated assay.