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-γ 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