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Thread: Development of Vaccines: From Discovery to Clinical Testing

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    Arrow Development of Vaccines: From Discovery to Clinical Testing

    Development of Vacines From Discovery to Clinical Testing
    by Manmohan Singh (Editor), Indresh K. Srivastava (Editor)



    Pages: 480 pages
    Publisher: --
    Edition: 1st., 2011
    Language: English
    ISBN:
    978-0470256374

    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.

    Table of Contents

    PREFACE ix
    CONTRIBUTORS xi
    PART 1 IMMUNOGEN DESIGN 1
    1 MICROBIAL VACCINE DESIGN: THE REVERSE VACCINOLOGY APPROACH 32 DESIGN AND DEVELOPMENT OF RECOMBINANT VACCINES WITH VIRAL PROPERTIES 19
    3 TOOLS FOR VACCINE DESIGN: PREDICTION AND VALIDATION OF HIGHLY IMMUNOGENIC AND CONSERVED CLASS II EPITOPES AND DEVELOPMENT OF EPITOPE-DRIVEN VACCINES 65
    PART 2 VACCINE PLATFORMS 95
    4 VIRUS-LIKE PARTICLE VACCINES: ADVANTAGES AND CHALLENGES 97
    5 DESIGN PLATFORMS OF NANOCAPSULES FOR HUMAN THERAPEUTICS OR VACCINES 125
    6 DESIGNING IMMUNOGENS FOR VACCINE DEVELOPMENT IN REFERENCE TO HIV 141
    7 EXPRESSION AND PURIFICATION OF RECOMBINANT PROTEINS FOR VACCINE APPLICATIONS 185
    8 DNA VACCINES FOR INFECTIOUS DIESASE 215
    9 DEVELOPING STABLE CELL LINES FOR THE PRODUCTION OF VACCINE ANTIGENS 243
    PART 3 CHARACTERIZATION OF IMMUNOGENS 261
    10 SPECTROSCOPY OF VACCINES 263
    11 BIOPHYSICAL CHARACTERIZATION OF PROTEIN ANTIGENS WITHIN VACCINE FORMULATIONS 293
    PART 4 FORMULATION OPTIMIZATION AND STABILITY EVALUATION 305
    12 STRUCTURAL CHARACTERISTICS PREDICT THE STABILITY OF HIV 307
    13 SELECTION OF OPTIMAL ADJUVANTS AND PRODUCT FACTORS THAT AFFECT VACCINE IMMUNOGENICITY 327
    14 LYOPHILIZATION AND STABILIZATION OF VACCINES 385
    15 EFFECT OF BUFFERS AND STABILIZERS ON VACCINE STABILITY AND EFFICACY 399
    PART 5 CLINICAL AND MANUFACTURING ISSUES 415
    16 SELECTION OF FINAL PRODUCT CONTAINERS 417
    17 FROM THE LAB TO THE CLINIC: FILING A PHASE I IND FOR AN INVESTIGATIONAL VACCINE 437
    INDEX 451

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    Default Re: Development of Vaccines: From Discovery to Clinical Testing

    Development of Vacines From Discovery to Clinical Testing
    1st. Edition, 2011




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