Current Trends in Monoclonal Antibody Development and Manufacturing

  • Steven J. Shire
  • Wayne Gombotz
  • Karoline Bechtold-Peters
  • James Andya
Part of the Biotechnology: Pharmaceutical Aspects book series (PHARMASP, volume XI)

Table of contents

  1. Front Matter
    Pages i-xiv
  2. Design Of Therapeutic MABS

    1. Front Matter
      Pages 8-8
    2. Wayne R. Gombotz, Steven J. Shire
      Pages 1-5
    3. Gholamreza Hassanzadeh Ghassabeh, Serge Muyldermans, Dirk Saerens
      Pages 29-48
  3. Expression and Production of MABS

  4. Recovery and Purification

    1. Front Matter
      Pages 74-74
    2. Michele M. Myers, Camille Keating, Joann Bannon, Donald S. Neblock, Peter W. Wojciechowski
      Pages 75-85
    3. Joachim K. Walter, Uwe Gottschalk
      Pages 87-99
  5. Formulation and Delivery

    1. Front Matter
      Pages 102-102
    2. Ann L. Daugherty, Randall J. Mrsny
      Pages 103-129
    3. Steven J. Shire, Zahra Shahrokh, Jun Liu
      Pages 131-147
  6. Analytics and Specification Setting for MABS

    1. Front Matter
      Pages 178-178
    2. Andrew W. Drake, David G. Myszka, Scott L. Klakamp
      Pages 179-192
    3. Reed J. Harris, Edward T. Chin, Frank Macchi, Rodney G. Keck, Bao-Jen Shyong, Victor T. Ling et al.
      Pages 193-205
    4. N. Harn, T. Spitznagel, M. Perkins, C. Allan, S. Shire, C. R. Middaugh
      Pages 229-246

About this book

Introduction

Monoclonal antibodies represent one of the fastest growing areas of new drug development within the pharmaceutical industry. Several blockbuster products have been approved over the past several years including Rituxan, Remicade, Avastin, Humira, and Herceptin. In addition, over 300 new drugs are currently in clinical trials. With both large, established biotechnology companies and small start-ups involved in the development of this important class of molecules, monoclonal antibodies products will become increasingly prevalent over the next decade.

Recently the regulatory review of monoclonal antibodies has been moved from Center for Biologics and Research to the Center for Drug Evaluation and Research (CDER) division of the US Food and Drug Administration. It is anticipated that CDER will expect a certain minimal amount of data to be provided as more of these products move through the regulatory pipeline. Current Trends in Monoclonal Antibody Development and Manufacturing will provide readers with an understanding of what is currently being done in the industry to develop, manufacture, and release monoclonal antibody products and what will be required for a successful regulatory submission.

Keywords

Antibodies Antigen Aspects Monoclonal Pharmaceutical Shire

Editors and affiliations

  • Steven J. Shire
    • 1
  • Wayne Gombotz
    • 2
  • Karoline Bechtold-Peters
    • 3
  • James Andya
    • 4
  1. 1.Genentech Inc.San FranciscoU.S.A.
  2. 2.Omeros CorporationSeattleU.S.A.
  3. 3.Boehringer Ingelheim Pharma KGBiberachGermany
  4. 4.Genentech, Inc.South San FranciscoU.S.A.

Bibliographic information

  • DOI https://doi.org/10.1007/978-0-387-76643-0
  • Copyright Information Springer-Verlag New York 2010
  • Publisher Name Springer, New York, NY
  • eBook Packages Biomedical and Life Sciences
  • Print ISBN 978-0-387-76642-3
  • Online ISBN 978-0-387-76643-0
  • About this book

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