Validation Of Cell-Based Assays In The Glp Setting - A Practical Guide

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.

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

List of contributors.
Preface.
Introduction (Uma Prabhakar).
1 Considerations while setting up cell-based assays (Marian Kelley).
2 Development, optimization and validation of cell-based assays – 1 (Marielena Mata and Thomas Lohr).
3 Development, optimization and validation of cell-based assays – 2 (Manjula Reddy and Uma Prabhakar).
4 Whole blood ex vivo stimulation assay development, optimization and validation (Manjula Reddy and Uma Prabhakar).
5 Immunohistochemistry assays in Good Laboratory Practice studies (Frank Lynch, Steve Bernstein and Hector Battifora).
6 Flow cytometric cell-based assays: an overview of general applications (Cuc Davis, Manjula Reddy, Thomas Williams and Uma Prabhakar).
7 T-cell surface markers in human peripheral whole blood using flow cytometry (Manjula Reddy, Cuc Davis, Hugh Davis, Charles Pendley and Uma Prabhakar).
8 Intracellular cytokine detection by flow cytometry (Julie G. Wilkinson, Carlos A. Aparicio and Wade E. Bolton).
9 Validating reference samples for comparison in a regulated ELISPOT assay (Magdalena Tary-Lehmann, Christina D. Hamm and Paul V. Lehmann).
10 IFN- ELISPOT assay validation (Manjula Reddy, Jackson Wong, Charles Pendley and Uma Prabhakar).
11 IL-5 ELISPOT assay validation (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 (Marielena Mata, Thomas Lohr and Jaymala Patel).
13 Development of validated neutralization bioassays (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 (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 (Uma Prabhakar and Marian Kelley).
Index.