Development of Vaccines

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.

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.

PREFACE ixCONTRIBUTORS xiPART 1 IMMUNOGEN DESIGN 11 MICROBIAL VACCINE DESIGN: THE REVERSE VACCINOLOGY APPROACH3Roberto Rosini, Michele A. Barocchi, and Rino Rappuoli2 DESIGN AND DEVELOPMENT OF RECOMBINANT VACCINES WITH VIRALPROPERTIES 19Gerd Lipowsky and Martin F. Bachmann3 TOOLS FOR VACCINE DESIGN: PREDICTION AND VALIDATION OF HIGHLYIMMUNOGENIC AND CONSERVED CLASS II EPITOPES AND DEVELOPMENT OFEPITOPE-DRIVEN VACCINES 65Anne S. De Groot, Matthew Ardito, Ryan Tassone, Paul KnopfLeonard Moise, and William MartinPART 2 VACCINE PLATFORMS 954 VIRUS-LIKE PARTICLE VACCINES: ADVANTAGES AND CHALLENGES97Ted M. Ross, Nitin Bhardwaj, Hermancia S. Eugene, Brendan M.Giles, Sean P. McBurney, Shannan L. Rossi, Kirsten Schneider-Ohrumand Xian-chun Tang5 DESIGN PLATFORMS OF NANOCAPSULES FOR HUMAN THERAPEUTICS ORVACCINES 125Masaaki Kawano, Li Xing, Kit S. Lam, Hiroshi Handa, TatsuoMiyamura, Susan Barnett, Indresh K. Srivastava, and R. HollandCheng6 DESIGNING IMMUNOGENS FOR VACCINE DEVELOPMENT IN REFERENCE TOHIV 141Aemro Kassa, Zohar Biron-Sorek, Pampi Sarkar, and Indresh K.Srivastava7 EXPRESSION AND PURIFICATION OF RECOMBINANT PROTEINS FORVACCINE 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 VACCINEANTIGENS 243Xiaotian Zhong, Zhijian Lu, Richard Zollner, Jimin Zhang, EmilyBraunstein, 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 WITHINVACCINE FORMULATIONS 293Padma Malyala, Derek O'Hagan, and Manmohan SinghPART 4 FORMULATION OPTIMIZATION AND STABILITYEVALUATION 30512 STRUCTURAL CHARACTERISTICS PREDICT THE STABILITY OF HIV307Zohar Biron-Sorek, Yide Sun, Elaine Kan, Jeanne Flandez, MichaelFranti, Jeffrey Ulmer, Susan Barnett, and Indresh K.Srivastava13 SELECTION OF OPTIMAL ADJUVANTS AND PRODUCT FACTORS THATAFFECT VACCINE IMMUNOGENICITY 327Wei Wang and Manmohan Singh14 LYOPHILIZATION AND STABILIZATION OF VACCINES 385James Chesko, Chris Fox, Tim Dutill, Thomas Vedvick, and SteveReed15 EFFECT OF BUFFERS AND STABILIZERS ON VACCINE STABILITY ANDEFFICACY 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 ANINVESTIGATIONAL VACCINE 437Kenneth G. SurowitzINDEX 451