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 The ASCRS Manual of Colon and Rectal Surgery by
Cover of the book Statistical Confidentiality by
Cover of the book Graves' Disease by
Cover of the book The ACL Handbook by
Cover of the book Biomaterials Associated Infection by
Cover of the book Discrete Event Systems by
Cover of the book Problem Solving Courts by
Cover of the book Surgical Mentoring by
Cover of the book Minimally Invasive Surgery in Orthopedics by
Cover of the book Semantic Web and Web Science by
Cover of the book Inherited Cancer Syndromes by
Cover of the book Cytopathology of Infectious Diseases by
Cover of the book Electrochemistry for the Environment by
Cover of the book Poverty and Exclusion in the Western Balkans by
Cover of the book The Manual of Dermatology 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