Development of Vaccines
From Discovery to Clinical Testing
Published on 4. May 2011
448 pages
978-1-118-02362-4 (ISBN)
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.
Reviews / Votes
"Given the scarcity of books on this topic, this titlewill be a welcome addition to those with an interest in vaccinedevelopment, mostly researchers and students. It will be auseful reference for occupational health professionals whose roleinvolves supervision of immunization programmes such as thoseworking in the National Health Service, some sectors of highereducation and the pharmaceutical industry." (Journalof Occupational Medicine, 1 January 2013)More details
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Additional editions
Book
07/2011
1st Edition
Wiley
€167.07
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Software
06/2011
Wiley
€187.37
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Persons
Manmohan Singh, PhD, is currently working as the Global Headof Vaccine Formulation Science at Novartis Vaccines and Diagnosticsin Cambridge, Massachusetts. Dr. Singh is a well-known expert inthe areas of vaccine formulations and adjuvant research and hasbeen working in vaccine R&D for the last twenty years. He hasauthored over 100 peer-reviewed manuscripts, review articles, andbook chapters in this area. Dr. Singh is on the editorial board ofseven international journals and has contributed to organizingseveral international vaccine conferences. He is also the editor ofVaccine Adjuvants and Delivery Systems (also published by Wiley).
Indresh K. Srivastava, PhD, is recognized as an expert inthe field of vaccine research, particularly immunogen design,purification, and characterization of vaccines. He has been workingin the field for more than twenty-five years; has published morethan seventy-five scientific papers in peer-reviewed journals; andauthored several reviews and book chapters. In addition, he hasserved on NIH special emphasis study sections focused on HIVVaccines. He is on the editorial board of Current HIV Research, andis reviewer for ten international journals. After spending morethan twelve years at Chiron/Novartis, Dr. Srivastava has joined theVaccine Research Institute, NIAID/NIH, to lead the purification andanalytical development of vaccine candidates. Prior to joiningChiron, he was an assistant professor (research) in microbiologyand immunology, Medical College of Pennsylvania, Philadelphia.
Content
PREFACE ix
CONTRIBUTORS xi
PART 1 IMMUNOGEN DESIGN 1
1 MICROBIAL VACCINE DESIGN: THE REVERSE VACCINOLOGY APPROACH3
Roberto Rosini, Michele A. Barocchi, and Rino Rappuoli
2 DESIGN AND DEVELOPMENT OF RECOMBINANT VACCINES WITH VIRALPROPERTIES 19
Gerd Lipowsky and Martin F. Bachmann
3 TOOLS FOR VACCINE DESIGN: PREDICTION AND VALIDATION OF HIGHLYIMMUNOGENIC AND CONSERVED CLASS II EPITOPES AND DEVELOPMENT OFEPITOPE-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 CHALLENGES97
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 ORVACCINES 125
Masaaki Kawano, Li Xing, Kit S. Lam, Hiroshi Handa, TatsuoMiyamura, Susan Barnett, Indresh K. Srivastava, and R. HollandCheng
6 DESIGNING IMMUNOGENS FOR VACCINE DEVELOPMENT IN REFERENCE TOHIV 141
Aemro Kassa, Zohar Biron-Sorek, Pampi Sarkar, and Indresh K.Srivastava
7 EXPRESSION AND PURIFICATION OF RECOMBINANT PROTEINS FORVACCINE 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 VACCINEANTIGENS 243
Xiaotian Zhong, Zhijian Lu, Richard Zollner, Jimin Zhang, EmilyBraunstein, 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 WITHINVACCINE FORMULATIONS 293
Padma Malyala, Derek O'Hagan, and Manmohan Singh
PART 4 FORMULATION OPTIMIZATION AND STABILITYEVALUATION 305
12 STRUCTURAL CHARACTERISTICS PREDICT THE STABILITY OF HIV307
Zohar Biron-Sorek, Yide Sun, Elaine Kan, Jeanne Flandez, MichaelFranti, Jeffrey Ulmer, Susan Barnett, and Indresh K.Srivastava
13 SELECTION OF OPTIMAL ADJUVANTS AND PRODUCT FACTORS THATAFFECT VACCINE IMMUNOGENICITY 327
Wei Wang and Manmohan Singh
14 LYOPHILIZATION AND STABILIZATION OF VACCINES 385
James Chesko, Chris Fox, Tim Dutill, Thomas Vedvick, and SteveReed
15 EFFECT OF BUFFERS AND STABILIZERS ON VACCINE STABILITY ANDEFFICACY 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 ANINVESTIGATIONAL VACCINE 437
Kenneth G. Surowitz
INDEX 451
