Current Trends in Monoclonal Antibody Development and Manufacturing - Couverture souple

Couverture souple

ISBN 10 : 1461424917 ISBN 13 : 9781461424918

Editeur : Springer, 2012

Synopsis

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.

A propos du livre

Présentation de l'éditeur

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.

Présentation de l'éditeur

This volume provides an understanding of the development, manufacturing techniques, and requirements of monoclonal antibodies. Covering one of the fastest growing areas of drug development, readers will find an informative text that describes the parameters for a successful regulatory submission.

Détails de l'édition

• Éditeur: Springer
• Date d'édition: 2012
• Langue: anglais
• ISBN 10: 1461424917
• ISBN 13: 9781461424918
• Reliure: Broché
• Nombre de pages: 368
• Éditeur: Shire Steven J., Gombotz Wayne, Bechtold-Peters Karoline, Andya James
• Coordonnées du fabricant: GPSR Kontakt; ProductSafety@springernature.com; ; Uhlandstraße 14; Stuttgart; 70182; Allemagne