Development of Antibody-Based Therapeutics

Translational Considerations

  • Mohammad A. Tabrizi
  • Gadi G. Bornstein
  • Scott L. Klakamp

Table of contents

  1. Front Matter
    Pages i-xiv
  2. Mohammad Tabrizi, Gadi Gazit Bornstein, Scott L. Klakamp
    Pages 1-7
  3. Ramesh R. Bhatt, John S. Haurum, C. Geoffrey Davis
    Pages 33-63
  4. Andrew W. Drake, Giuseppe A. Papalia
    Pages 95-139
  5. Mohammad Tabrizi, Gadi Gazit Bornstein
    Pages 375-390
  6. Rong Deng, Joseph P. Balthasar
    Pages 391-404
  7. Anthony Carvalloza, Mohammad Fallahi, Sahba Tabrizifard
    Pages 405-417
  8. Mohammad Tabrizi, Gadi Gazit Bornstein, Scott L. Klakamp
    Pages 419-421

About this book

Introduction

Development of Antibody-Based Therapeutics: Translational Considerations examines important considerations necessary for the design of effective translational strategies during the development of antibody-based therapeutics. Translational strategies for development of antibody-based therapeutics require an understanding of the relationship between the ‘unit dose’ and ‘unit effect’ with respect to both beneficial and deleterious biological effects from early stages of development. The flow of information across various stages of development should provide opportunities to facilitate selection of more effective novel and next-generation drug candidates.  Successful strategies for the development of monoclonal antibodies require integration of knowledge with regards to target antigen properties in health and disease, as well as antibody design criteria including affinity, isotype selection, pharmacokinetics/pharmacodynamics (PK/PD) properties, antibody cross-reactivity across species, and safety. Selection and evaluation of appropriate biomarkers in early preclinical development in “relevant” animal models should allow identification of potential risks and liabilities of an antibody drug candidate to humans and establishment of safe First-In-Human (FIH) dosing strategies.  This volume provides a comprehensive review of the topics critical for establishing successful translational strategies for the development of antibody-based therapeutics.

Keywords

Antibody Antibody-Based Bornstein Considerations Development Klakamp Tabrizi Therepeutic Translational

Editors and affiliations

  • Mohammad A. Tabrizi
    • 1
  • Gadi G. Bornstein
    • 2
  • Scott L. Klakamp
    • 3
  1. 1.Merck Research LaboratoryMerck & CO Inc.Palo AltoUSA
  2. 2.Pfizer CTI- New YorkNew YorkUSA
  3. 3.Takeda California, Inc.South San FranciscoUSA

Bibliographic information

  • DOI https://doi.org/10.1007/978-1-4419-5955-3
  • Copyright Information Springer Science+Business Media New York 2012
  • Publisher Name Springer, New York, NY
  • eBook Packages Medicine
  • Print ISBN 978-1-4419-5953-9
  • Online ISBN 978-1-4419-5955-3
  • About this book