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

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

Editor(s): Uma Prabhakar, Marian Kelley

Published Online: 8 APR 2008

Print ISBN: 9780470028766

Online ISBN: 9780470987810

DOI: 10.1002/9780470987810

About this Book

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. 

Table of contents

    1. You have free access to this content
    2. You have free access to this content
    3. Chapter 10

      IFN-γ ELISPOT Assay Validation (pages 147–172)

      Manjula Reddy, Jackson Wong, Charles Pendley and Uma Prabhakar

    4. Chapter 11

      IL-5 ELISPOT Assay Validation (pages 173–191)

      Manjula Reddy, Jackson Wong, Hugh Davis, Charles Pendley and Uma Prabhakar

    5. Chapter 13

      Development of Validated Neutralization Bioassays (pages 209–237)

      Manoj Rajadhyaksha, Manjula Reddy, Jaime Bald, Amy Fraunfelter, Persymphonie Miller, Marian Kelley and Uma Prabhakar

    6. Chapter 14

      Endpoint Assays in HIV-1 Vaccine Trials: Functioning in a Good Laboratory Practices Environment (pages 239–275)

      Patricia D'Souza, Josephine H. Cox, Guido Ferrari, Nina Thapa Kunwar, Victoria Polonis and Marcella Sarzotti-Kelsoe

    7. You have free access to this content