基本説明
Covers vaccine expression, purification, formulation, pre-clinical testing and regulatory submissions.
Full 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.
Contents
PREFACE ix CONTRIBUTORS xi
PART 1 IMMUNOGEN DESIGN 1
1 MICROBIAL VACCINE DESIGN: THE REVERSE VACCINOLOGY APPROACH 3
Roberto Rosini, Michele A. Barocchi, and Rino Rappuoli
2 DESIGN AND DEVELOPMENT OF RECOMBINANT VACCINES WITH VIRAL PROPERTIES 19
Gerd Lipowsky and Martin F. Bachmann
3 TOOLS FOR VACCINE DESIGN: PREDICTION AND VALIDATION OF HIGHLY IMMUNOGENIC AND CONSERVED CLASS II EPITOPES AND DEVELOPMENT OF EPITOPE-DRIVEN VACCINES 65
Anne S. De Groot, Matthew Ardito, Ryan Tassone, Paul Knopf, Leonard Moise, and William Martin
PART 2 VACCINE PLATFORMS 95
4 VIRUS-LIKE PARTICLE VACCINES: ADVANTAGES AND CHALLENGES 97
Ted M. Ross, Nitin Bhardwaj, Hermancia S. Eugene, Brendan M. Giles, Sean P. McBurney, Shannan L. Rossi, Kirsten Schneider-Ohrum, and Xian-chun Tang
5 DESIGN PLATFORMS OF NANOCAPSULES FOR HUMAN THERAPEUTICS OR VACCINES 125
Masaaki Kawano, Li Xing, Kit S. Lam, Hiroshi Handa, Tatsuo Miyamura, Susan Barnett, Indresh K. Srivastava, and R. Holland Cheng
6 DESIGNING IMMUNOGENS FOR VACCINE DEVELOPMENT IN REFERENCE TO HIV 141
Aemro Kassa, Zohar Biron-Sorek, Pampi Sarkar, and Indresh K. Srivastava
7 EXPRESSION AND PURIFICATION OF RECOMBINANT PROTEINS FOR VACCINE APPLICATIONS 185
Carlo Zambonelli, Deeann Martinez-Guzmann, and Indresh K. Srivastava
8 DNA VACCINES FOR INFECTIOUS DIESASE 215
Samuel Stepenson, Manmohan Singh, and Indresh K. Srivastava
9 DEVELOPING STABLE CELL LINES FOR THE PRODUCTION OF VACCINE ANTIGENS 243
Xiaotian Zhong, Zhijian Lu, Richard Zollner, Jimin Zhang, Emily Braunstein, Narender Kalyan, and Maninder Sidhu
PART 3 CHARACTERIZATION OF IMMUNOGENS 261
10 SPECTROSCOPY OF VACCINES 263
C. Russell Middaugh and Sangeeta B. Joshi
11 BIOPHYSICAL CHARACTERIZATION OF PROTEIN ANTIGENS WITHIN VACCINE FORMULATIONS 293
Padma Malyala, Derek O'Hagan, and Manmohan Singh
PART 4 FORMULATION OPTIMIZATION AND STABILITY EVALUATION 305
12 STRUCTURAL CHARACTERISTICS PREDICT THE STABILITY OF HIV 307
Zohar Biron-Sorek, Yide Sun, Elaine Kan, Jeanne Flandez, Michael Franti, Jeffrey Ulmer, Susan Barnett, and Indresh K. Srivastava
13 SELECTION OF OPTIMAL ADJUVANTS AND PRODUCT FACTORS THAT AFFECT VACCINE IMMUNOGENICITY 327
Wei Wang and Manmohan Singh
14 LYOPHILIZATION AND STABILIZATION OF VACCINES 385
James Chesko, Chris Fox, Tim Dutill, Thomas Vedvick, and Steve Reed
15 EFFECT OF BUFFERS AND STABILIZERS ON VACCINE STABILITY AND EFFICACY 399
Shireesh P. Apte and Sydney O. Ugwu
PART 5 CLINICAL AND MANUFACTURING ISSUES 415
16 SELECTION OF FINAL PRODUCT CONTAINERS 417
Luis Baez and Adrian Distler
17 FROM THE LAB TO THE CLINIC: FILING A PHASE I IND FOR AN INVESTIGATIONAL VACCINE 437
Kenneth G. Surowitz
INDEX 451
