Development of Vaccines

From Discovery to Clinical Testing

Inbunden, Engelska, 2011

Av Manmohan Singh, Indresh K. Srivastava, Indresh K Srivastava

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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.

Produktinformation

Utgivningsdatum2011-07-28
Mått160 x 242 x 30 mm
Vikt839 g
FormatInbunden
SpråkEngelska
Antal sidor472
FörlagJohn Wiley & Sons Inc
ISBN9780470256374

Tillhör följande kategorier

Kemi inom Naturvetenskap och teknik
Klinisk medicin och internmedicin inom Medicin
Biologi inom Naturvetenskap och teknik

Manmohan Singh, PhD, is currently working as the Global Head of Vaccine Formulation Science at Novartis Vaccines and Diagnostics in Cambridge, Massachusetts. Dr. Singh is a well-known expert in the areas of vaccine formulations and adjuvant research and has been working in vaccine R&D for the last twenty years. He has authored over 100 peer-reviewed manuscripts, review articles, and book chapters in this area. Dr. Singh is on the editorial board of seven international journals and has contributed to organizing several international vaccine conferences. He is also the editor of Vaccine Adjuvants and Delivery Systems (also published by Wiley). Indresh K. Srivastava, PhD, is recognized as an expert in the field of vaccine research, particularly immunogen design, purification, and characterization of vaccines. He has been working in the field for more than twenty-five years; has published more than seventy-five scientific papers in peer-reviewed journals; and authored several reviews and book chapters. In addition, he has served on NIH special emphasis study sections focused on HIV Vaccines. He is on the editorial board of Current HIV Research, and is reviewer for ten international journals. After spending more than twelve years at Chiron/Novartis, Dr. Srivastava has joined the Vaccine Research Institute, NIAID/NIH, to lead the purification and analytical development of vaccine candidates. Prior to joining Chiron, he was an assistant professor (research) in microbiology and immunology, Medical College of Pennsylvania, Philadelphia.

PREFACE ix CONTRIBUTORS xiPART 1 IMMUNOGEN DESIGN 11 MICROBIAL VACCINE DESIGN: THE REVERSE VACCINOLOGY APPROACH 3Roberto Rosini, Michele A. Barocchi, and Rino Rappuoli2 DESIGN AND DEVELOPMENT OF RECOMBINANT VACCINES WITH VIRAL PROPERTIES 19Gerd Lipowsky and Martin F. Bachmann3 TOOLS FOR VACCINE DESIGN: PREDICTION AND VALIDATION OF HIGHLY IMMUNOGENIC AND CONSERVED CLASS II EPITOPES AND DEVELOPMENT OF EPITOPE-DRIVEN VACCINES 65Anne S. De Groot, Matthew Ardito, Ryan Tassone, Paul Knopf, Leonard Moise, and William MartinPART 2 VACCINE PLATFORMS 954 VIRUS-LIKE PARTICLE VACCINES: ADVANTAGES AND CHALLENGES 97Ted M. Ross, Nitin Bhardwaj, Hermancia S. Eugene, Brendan M. Giles, Sean P. McBurney, Shannan L. Rossi, Kirsten Schneider-Ohrum, and Xian-chun Tang5 DESIGN PLATFORMS OF NANOCAPSULES FOR HUMAN THERAPEUTICS OR VACCINES 125Masaaki Kawano, Li Xing, Kit S. Lam, Hiroshi Handa, Tatsuo Miyamura, Susan Barnett, Indresh K. Srivastava, and R. Holland Cheng6 DESIGNING IMMUNOGENS FOR VACCINE DEVELOPMENT IN REFERENCE TO HIV 141Aemro Kassa, Zohar Biron-Sorek, Pampi Sarkar, and Indresh K. Srivastava7 EXPRESSION AND PURIFICATION OF RECOMBINANT PROTEINS FOR VACCINE APPLICATIONS 185Carlo Zambonelli, Deeann Martinez-Guzmann, and Indresh K. Srivastava8 DNA VACCINES FOR INFECTIOUS DIESASE 215Samuel Stepenson, Manmohan Singh, and Indresh K. Srivastava9 DEVELOPING STABLE CELL LINES FOR THE PRODUCTION OF VACCINE ANTIGENS 243Xiaotian Zhong, Zhijian Lu, Richard Zollner, Jimin Zhang, Emily Braunstein, Narender Kalyan, and Maninder SidhuPART 3 CHARACTERIZATION OF IMMUNOGENS 26110 SPECTROSCOPY OF VACCINES 263C. Russell Middaugh and Sangeeta B. Joshi11 BIOPHYSICAL CHARACTERIZATION OF PROTEIN ANTIGENS WITHIN VACCINE FORMULATIONS 293Padma Malyala, Derek O’Hagan, and Manmohan SinghPART 4 FORMULATION OPTIMIZATION AND STABILITY EVALUATION 30512 STRUCTURAL CHARACTERISTICS PREDICT THE STABILITY OF HIV 307Zohar Biron-Sorek, Yide Sun, Elaine Kan, Jeanne Flandez, Michael Franti, Jeffrey Ulmer, Susan Barnett, and Indresh K. Srivastava13 SELECTION OF OPTIMAL ADJUVANTS AND PRODUCT FACTORS THAT AFFECT VACCINE IMMUNOGENICITY 327Wei Wang and Manmohan Singh14 LYOPHILIZATION AND STABILIZATION OF VACCINES 385James Chesko, Chris Fox, Tim Dutill, Thomas Vedvick, and Steve Reed15 EFFECT OF BUFFERS AND STABILIZERS ON VACCINE STABILITY AND EFFICACY 399Shireesh P. Apte and Sydney O. UgwuPART 5 CLINICAL AND MANUFACTURING ISSUES 41516 SELECTION OF FINAL PRODUCT CONTAINERS 417Luis Baez and Adrian Distler17 FROM THE LAB TO THE CLINIC: FILING A PHASE I IND FOR AN INVESTIGATIONAL VACCINE 437Kenneth G. SurowitzINDEX 451

“Given the scarcity of books on this topic, this title will be a welcome addition to those with an interest in vaccine development, mostly researchers and students. It will be a useful reference for occupational health professionals whose role involves supervision of immunization programmes such as those working in the National Health Service, some sectors of higher education and the pharmaceutical industry.” (Journal of Occupational Medicine, 1 January 2013)