Validation of Cell-Based Assays in the GLP Setting

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.