Biotechnology: Pharmaceutical Aspects

Current Trends in Monoclonal Antibody Development and Manufacturing

Editors: Shire, S.J., Gombotz, W., Bechtold-Peters, K., Andya, J. (Eds.)

  • Covers one of the fastest growing areas of new drug development within the pharmaceutical industry
  • Offers insight on monoclonal antibodies, products that will become increasingly prevalent over the next decade
  • Describes what is currently being done in the industry to develop, manufacture, and release monoclonal antibody products
  • Explains what will be required for a successful regulatory submission
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eBook $229.00
price for USA (gross)
  • ISBN 978-0-387-76643-0
  • Digitally watermarked, DRM-free
  • Included format: EPUB, PDF
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $289.00
price for USA
  • ISBN 978-0-387-76642-3
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
Softcover $289.00
price for USA
  • ISBN 978-1-4614-2491-8
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
About this book

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.

Table of contents (19 chapters)

  • Introduction

    Gombotz, Wayne R. (et al.)

    Pages 1-5

  • CDR Repair: A Novel Approach to Antibody Humanization

    Dennis, Mark S.

    Pages 9-28

  • Nanobodies, Single-Domain Antigen-Binding Fragments of Camelid Heavy-Chain Antibodies

    Ghassabeh, Gholamreza Hassanzadeh (et al.)

    Pages 29-48

  • GPEx┬« A Flexible Method for the Rapid Generation of Stable, High Expressing, Antibody Producing Mammalian Cell Lines

    Bleck, Gregory T.

    Pages 51-62

  • Advancing Our Cell Culture Platform: Incorporating Lessons Learned and New Technologies

    Heath, Carole

    Pages 63-72

Buy this book

eBook $229.00
price for USA (gross)
  • ISBN 978-0-387-76643-0
  • Digitally watermarked, DRM-free
  • Included format: EPUB, PDF
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $289.00
price for USA
  • ISBN 978-0-387-76642-3
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
Softcover $289.00
price for USA
  • ISBN 978-1-4614-2491-8
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
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Bibliographic Information

Bibliographic Information
Book Title
Current Trends in Monoclonal Antibody Development and Manufacturing
Editors
  • Steven J. Shire
  • Wayne Gombotz
  • Karoline Bechtold-Peters
  • James Andya
Series Title
Biotechnology: Pharmaceutical Aspects
Series Volume
XI
Copyright
2010
Publisher
Springer-Verlag New York
Copyright Holder
Springer-Verlag New York
eBook ISBN
978-0-387-76643-0
DOI
10.1007/978-0-387-76643-0
Hardcover ISBN
978-0-387-76642-3
Softcover ISBN
978-1-4614-2491-8
Edition Number
1
Number of Pages
XIV, 354
Topics