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Validation of Cell-Based Assays in the GLP Setting: A Practical Guide / Edition 1

Validation of Cell-Based Assays in the GLP Setting: A Practical Guide / Edition 1

by Uma Prabhakar, Marian Kelley


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Validation of Cell-Based Assays in the GLP Setting: A Practical Guide / Edition 1

The use of cell-based assays within pharmaceutical andbiotechnology companies is driven in large part by the need toevaluate the plethora of drug targets derived from genomics andproteomics. In addition, the potential of biomarkers to facilitatethe development of effective and safe drugs is being recognized asan integral part of all phases of drug development, and cell-basedtechnologies are a critical part of biomarker discovery anddevelopment. Despite this critical role, cell-based assays have notbeen standardized and made compliant with Good Laboratory Practiceguidelines.  

In this book, the editors have collected assays for whichvalidation procedures have been developed, making this a vitalpurchase for anyone using such assays in drug development.

This book: 

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

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

Product Details

ISBN-13: 9780470028766
Publisher: Wiley
Publication date: 06/23/2008
Pages: 312
Product dimensions: 6.80(w) x 9.90(h) x 0.90(d)

About the Author

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

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

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Table of Contents

List of contributors ix

Preface xiii

Introduction xvii
Uma Prabhakar

1 Considerations while setting up cell-based assays 1
Marian Kelley

2 Development, optimization and validation of cell-based assays – 1 11
Marielena Mata and Thomas Lohr

3 Development, optimization and validation of cell-based assays – 2 25
Manjula Reddy and Uma Prabhakar

4 Whole blood ex vivo stimulation assay development, optimization and validation 37
Manjula Reddy and Uma Prabhakar

5 Immunohistochemistry assays in Good Laboratory Practice studies 49
Frank Lynch, Steve Bernstein and Hector Battifora

6 Flow cytometric cell-based assays: an overview of general applications 73
Cuc Davis, Manjula Reddy, Thomas Williams and Uma Prabhakar

7 T-cell surface markers in human peripheral whole blood using flow cytometry 85
Manjula Reddy, Cuc Davis, Hugh Davis, Charles Pendley and Uma Prabhakar

8 Intracellular cytokine detection by flow cytometry 107
Julie G. Wilkinson, Carlos A. Aparicio and Wade E. Bolton

9 Validating reference samples for comparison in a regulated ELISPOT assay 127
Magdalena Tary-Lehmann, Christina D. Hamm and Paul V. Lehmann

10 IFN-_ ELISPOT assay validation 147
Manjula Reddy, Jackson Wong, Charles Pendley and Uma Prabhakar

11 IL-5 ELISPOT assay validation 173
Manjula Reddy, Jackson Wong, Hugh Davis, Charles Pendley and Uma Prabhakar

12 Validation of the Cylex technology to measure T and B cell activation capacity in clinical trials 193
Marielena Mata, Thomas Lohr and Jaymala Patel

13 Development of validated neutralization bioassays 209
Manoj Rajadhyaksha, Manjula Reddy, Jaime Bald, Amy Fraunfelter, Persymphonie Miller, Marian Kelley and Uma Prabhakar

14 Endpoint assays in HIV-1 vaccine trials: functioning in a Good Laboratory Practices environment 239
Patricia D’Souza, Josephine H. Cox, Guido Ferrari, Nina Thapa Kunwar, Victoria Polonis and Marcella Sarzotti-Kelsoe

15 The future direction of cell-based assays 277
Uma Prabhakar and Marian Kelley

Index 283

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