Name: current trends in monoclonal antibody development and manufacturing (en Inglés)
SKU: 25259092
Price: 203.94 USD
Availability: InStock
Author: Shire, Steven J. ; Gombotz, Wayne ; Bechtold-Peters, Karoline
ISBN: 9781461424918

portada current trends in monoclonal antibody development and manufacturing (en Inglés)

current trends in monoclonal antibody development and manufacturing (en Inglés)

Formato

Libro Físico

Ilustrado por

Steven J. Shire

Wayne Gombotz

Karoline Bechtold-Peters

Editorial

Springer

Autor

Shire, Steven J. ; Gombotz, Wayne ; Bechtold-Peters, Karoline

Año

2012

Idioma

Inglés

N° páginas

354

Encuadernación

Tapa Blanda

Dimensiones

25.4x17.8x1.9 cm

Peso

0.64 kg.

ISBN

1461424917

ISBN13

9781461424918

Categorías

Farmacología
Neurología y neurofisiología clínicas
Neurociencias

current trends in monoclonal antibody development and manufacturing (en Inglés)

Steven J. Shire (Ilustrado por) · Wayne Gombotz (Ilustrado por) · Karoline Bechtold-Peters (Ilustrado por) · Springer · Tapa Blanda

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Reseña del libro "current trends in monoclonal antibody development and manufacturing (en Inglés)"

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.