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Development of Vacines From Discovery to Clinical Testing
by Manmohan Singh (Editor), Indresh K. Srivastava (Editor)
Pages: 480 pages
Publisher: --
Edition: 1st., 2011
Language: English
ISBN: 978-0470256374
Description
Development of Vaccines: From Discovery to Clinical Testing outlines the critical steps, and analytical tools and techniques, needed to take a vaccine from discovery through a successful clinical trial. Contributions from leading experts in the critical areas of vaccine expression, purification, formulation, pre-clinical testing and regulatory submissions make this book an authoritative collection of issues, challenges and solutions for progressing a biologic drug formulation from its early stage of discovery into its final clinical testing. A section with details and real-life experiences of toxicology testing and regulatory filing for vaccines is also included.
Table of Contents
PREFACE ix
CONTRIBUTORS xi
PART 1 IMMUNOGEN DESIGN 1
1 MICROBIAL VACCINE DESIGN: THE REVERSE VACCINOLOGY APPROACH 32 DESIGN AND DEVELOPMENT OF RECOMBINANT VACCINES WITH VIRAL PROPERTIES 19
3 TOOLS FOR VACCINE DESIGN: PREDICTION AND VALIDATION OF HIGHLY IMMUNOGENIC AND CONSERVED CLASS II EPITOPES AND DEVELOPMENT OF EPITOPE-DRIVEN VACCINES 65
PART 2 VACCINE PLATFORMS 95
4 VIRUS-LIKE PARTICLE VACCINES: ADVANTAGES AND CHALLENGES 97
5 DESIGN PLATFORMS OF NANOCAPSULES FOR HUMAN THERAPEUTICS OR VACCINES 125
6 DESIGNING IMMUNOGENS FOR VACCINE DEVELOPMENT IN REFERENCE TO HIV 141
7 EXPRESSION AND PURIFICATION OF RECOMBINANT PROTEINS FOR VACCINE APPLICATIONS 185
8 DNA VACCINES FOR INFECTIOUS DIESASE 215
9 DEVELOPING STABLE CELL LINES FOR THE PRODUCTION OF VACCINE ANTIGENS 243
PART 3 CHARACTERIZATION OF IMMUNOGENS 261
10 SPECTROSCOPY OF VACCINES 263
11 BIOPHYSICAL CHARACTERIZATION OF PROTEIN ANTIGENS WITHIN VACCINE FORMULATIONS 293
PART 4 FORMULATION OPTIMIZATION AND STABILITY EVALUATION 305
12 STRUCTURAL CHARACTERISTICS PREDICT THE STABILITY OF HIV 307
13 SELECTION OF OPTIMAL ADJUVANTS AND PRODUCT FACTORS THAT AFFECT VACCINE IMMUNOGENICITY 327
14 LYOPHILIZATION AND STABILIZATION OF VACCINES 385
15 EFFECT OF BUFFERS AND STABILIZERS ON VACCINE STABILITY AND EFFICACY 399
PART 5 CLINICAL AND MANUFACTURING ISSUES 415
16 SELECTION OF FINAL PRODUCT CONTAINERS 417
17 FROM THE LAB TO THE CLINIC: FILING A PHASE I IND FOR AN INVESTIGATIONAL VACCINE 437
INDEX 451
by Manmohan Singh (Editor), Indresh K. Srivastava (Editor)
Pages: 480 pages
Publisher: --
Edition: 1st., 2011
Language: English
ISBN: 978-0470256374
Description
Development of Vaccines: From Discovery to Clinical Testing outlines the critical steps, and analytical tools and techniques, needed to take a vaccine from discovery through a successful clinical trial. Contributions from leading experts in the critical areas of vaccine expression, purification, formulation, pre-clinical testing and regulatory submissions make this book an authoritative collection of issues, challenges and solutions for progressing a biologic drug formulation from its early stage of discovery into its final clinical testing. A section with details and real-life experiences of toxicology testing and regulatory filing for vaccines is also included.
Table of Contents
PREFACE ix
CONTRIBUTORS xi
PART 1 IMMUNOGEN DESIGN 1
1 MICROBIAL VACCINE DESIGN: THE REVERSE VACCINOLOGY APPROACH 32 DESIGN AND DEVELOPMENT OF RECOMBINANT VACCINES WITH VIRAL PROPERTIES 19
3 TOOLS FOR VACCINE DESIGN: PREDICTION AND VALIDATION OF HIGHLY IMMUNOGENIC AND CONSERVED CLASS II EPITOPES AND DEVELOPMENT OF EPITOPE-DRIVEN VACCINES 65
PART 2 VACCINE PLATFORMS 95
4 VIRUS-LIKE PARTICLE VACCINES: ADVANTAGES AND CHALLENGES 97
5 DESIGN PLATFORMS OF NANOCAPSULES FOR HUMAN THERAPEUTICS OR VACCINES 125
6 DESIGNING IMMUNOGENS FOR VACCINE DEVELOPMENT IN REFERENCE TO HIV 141
7 EXPRESSION AND PURIFICATION OF RECOMBINANT PROTEINS FOR VACCINE APPLICATIONS 185
8 DNA VACCINES FOR INFECTIOUS DIESASE 215
9 DEVELOPING STABLE CELL LINES FOR THE PRODUCTION OF VACCINE ANTIGENS 243
PART 3 CHARACTERIZATION OF IMMUNOGENS 261
10 SPECTROSCOPY OF VACCINES 263
11 BIOPHYSICAL CHARACTERIZATION OF PROTEIN ANTIGENS WITHIN VACCINE FORMULATIONS 293
PART 4 FORMULATION OPTIMIZATION AND STABILITY EVALUATION 305
12 STRUCTURAL CHARACTERISTICS PREDICT THE STABILITY OF HIV 307
13 SELECTION OF OPTIMAL ADJUVANTS AND PRODUCT FACTORS THAT AFFECT VACCINE IMMUNOGENICITY 327
14 LYOPHILIZATION AND STABILIZATION OF VACCINES 385
15 EFFECT OF BUFFERS AND STABILIZERS ON VACCINE STABILITY AND EFFICACY 399
PART 5 CLINICAL AND MANUFACTURING ISSUES 415
16 SELECTION OF FINAL PRODUCT CONTAINERS 417
17 FROM THE LAB TO THE CLINIC: FILING A PHASE I IND FOR AN INVESTIGATIONAL VACCINE 437
INDEX 451
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