Overview
- Essential reading for companies and research institutions working on the development of biopharmaceuticals
- Examines two product classes - therapeutic enzymes and monoclonal antibodies - as examples of what modifications can be made to improve clinical performance
- Discusses novel platforms that exceed monoclonal antibodies with respect to potency and hence efficacy
Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series (AAPS, volume 19)
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Table of contents (16 chapters)
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Therapeutic Enzymes
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Monoclonal Antibodies: Degradation Mechanisms and Potential Improvements
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New Platforms
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Economic and Regulatory Considerations
Keywords
About this book
Editors and Affiliations
About the editors
Dr. Amy Rosenberg received her M.D. from Albert Einstein College of Medicine, trained in internal medicine and infectious diseases and is Board Certified in Internal Medicine. She was a post-doctoral fellow in Al Singer’s Laboratory in the NCI before coming to CBER, FDA. She is Director of the Division of Therapeutic Proteins, a division that regulates diverse protein therapeutics, including enzyme replacement therapies, hematologic and somatic cell growth factors and immunomodulatory agents including interferons and interleukins. Her particular interests are in tolerance induction in diverse clinical settings including autoimmunity, therapeutic protein immunogenicity and transplantation.
Dr. Barthélemy Demeule obtained his Ph.D. at the University of Geneva, Switzerland, where he started his investigations on the physico-chemical stability of biopharmaceuticals. After a postdoctoral work at Genentech, Inc. focused on the effect of the in vivo environment on antibody-antigen interactions, he stayed in the company where he held positions of increasing responsibilities. He currently leads a group of scientists responsible for the pharmaceutical development of monoclonal antibodies in the last phases of clinical development. He also serves on the editorial board of the European Journal of Pharmaceutics and Biopharmaceutics.
Bibliographic Information
Book Title: Biobetters
Book Subtitle: Protein Engineering to Approach the Curative
Editors: Amy Rosenberg, Barthélemy Demeule
Series Title: AAPS Advances in the Pharmaceutical Sciences Series
DOI: https://doi.org/10.1007/978-1-4939-2543-8
Publisher: Springer New York, NY
eBook Packages: Biomedical and Life Sciences, Biomedical and Life Sciences (R0)
Copyright Information: American Association of Pharmaceutical Scientists 2015
Hardcover ISBN: 978-1-4939-2542-1Published: 23 August 2015
Softcover ISBN: 978-1-4939-4994-6Published: 22 October 2016
eBook ISBN: 978-1-4939-2543-8Published: 21 August 2015
Series ISSN: 2210-7371
Series E-ISSN: 2210-738X
Edition Number: 1
Number of Pages: XV, 378
Number of Illustrations: 28 b/w illustrations, 22 illustrations in colour
Topics: Pharmaceutical Sciences/Technology, Biomedicine general