Current Trends in Monoclonal Antibody Development and Manufacturing

Nonfiction, Health & Well Being, Medical, Medical Science, Pharmacology, Specialties, Internal Medicine, Neuroscience, Science & Nature, Science
Cover of the book Current Trends in Monoclonal Antibody Development and Manufacturing by , Springer New York
View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart
Author: ISBN: 9780387766430
Publisher: Springer New York Publication: November 11, 2009
Imprint: Springer Language: English
Author:
ISBN: 9780387766430
Publisher: Springer New York
Publication: November 11, 2009
Imprint: Springer
Language: English

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.

View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart

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.

More books from Springer New York

Cover of the book Ventricular/Vascular Coupling by
Cover of the book High Performance Marine Vessels by
Cover of the book The Mathematics of Paul Erdős I by
Cover of the book Renal Cell Carcinoma by
Cover of the book Advanced Thermal Management Materials by
Cover of the book Gender and Thought: Psychological Perspectives by
Cover of the book Distribution Ecology by
Cover of the book Stalking the Wild Sweetgrass by
Cover of the book Conventional Three-Phase Fixed-Bed Technologies by
Cover of the book Neurovascular Neuropsychology by
Cover of the book Enzymes in Anesthesiology by
Cover of the book Applications of Biotechnology in Oncology by
Cover of the book Language and Recursion by
Cover of the book Pathology by
Cover of the book The Biological Activity of Phytochemicals by
We use our own "cookies" and third party cookies to improve services and to see statistical information. By using this website, you agree to our Privacy Policy