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

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.