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

Front Cover
Uma Prabhakar, Marian Kelley
John Wiley & Sons, Apr 30, 2008 - Science - 312 pages
The use of cell-based assays within pharmaceutical and biotechnology companies is driven in large part by the need to evaluate the plethora of drug targets derived from genomics and proteomics. In addition, the potential of biomarkers to facilitate the development of effective and safe drugs is being recognized as an integral part of all phases of drug development, and cell-based technologies are a critical part of biomarker discovery and development. Despite this critical role, cell-based assays have not been standardized and made compliant with Good Laboratory Practice guidelines.

In this book, the editors have collected assays for which validation procedures have been developed, making this a vital purchase for anyone using such assays in drug development.

This book:

  • Describes the development, optimization and validation of cell-based assays, including procedural documentation required for Good Laboratory Practice
  • Presents validations of cell-based assays for select targets, with step-by-step instructions, allowing the reader to reproduce the assay conditions and results
  • Provides details of techniques used in the evaluation of immunodeficiency, autoimmune and oncological disorders, including assessment of cancer vaccines
  • Offers a compendium of validation parameters that need to be considered when using these methods to develop a new drug
  • Includes detailed protocols for the evaluation of cytokines and of neutralizing antibodies directed against protein therapeutics

Validation of Cell-based Assays in the GLP Setting provides the professional with an invaluable reference source, featuring key guidelines. The book will prove extremely useful to all scientists working in the areas of drug development.

 

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Contents

1 Considerations while setting up cellbased assays
1
2 Development optimization and validation of cellbased assays 1
11
3 Development optimization and validation of cellbased assays 2
25
4 Whole blood ex vivo stimulation assay development optimization and validation
37
5 Immunohistochemistry assays in Good Laboratory Practice studies
49
6 Flow cytometric cellbased assays an overview of general applications
73
7 Tcell surface markers in human peripheral whole blood using flow cytometry
85
8 Intracellular cytokine detection by flow cytometry
107
10 IFNgamma ELISPOT assay validation
147
11 IL5 ELISPOT assay validation
173
12 Validation of the Cylex technology to measure T and B cell activation capacity in clinical trials
193
13 Development of validated neutralization bioassays
209
14 Endpoint assays in HIV1 vaccine trials functioning in a Good Laboratory Practices environment
239
15 The future direction of cellbased assays
277
Index
283
Plates
292

9 Validating reference samples for comparison in a regulated ELISPOT assay
127

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About the author (2008)

Uma Prabhakar, Ph. D. Director, Department of Clinical Pharmacology & Experimental Medicine, Centocor Inc, PA, USA

Marian Kelley, M.A., Director of Compliance, Department of Clinical Pharmacology & Experimental Medicine, Centocor Inc, PA, USA

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