CiNii Books - Development of vaccines : from discovery to clinical testing

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 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

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Development of vaccines : from discovery to clinical testing

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