Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals - Hardcover

Hardcover

ISBN 10: 0470118121 ISBN 13: 9780470118122

Publisher: Wiley, 2010

Synopsis

Because pharmaceutical scientists lack information about biopharmaceutical product manufacture and commercialization, this book comprehensively covers fundamentals and essential pathways for each production phase; as well as the purpose, function, and relation to other stages in the product development process. It provides case histories related to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions. And it offers the perspective and experience of production and manufacturing of the drugs, making this a vital for pharmaceutical, biotech, regulatory, and academic researchers and professionals.

About this title

Review

"This book is intended as a comprehensive look at the growing area of producing and manufacturing biopharmaceuticals, right the way through from development to commercialisation. Each chapter is written by an expert in that area and authors hail from both industry and academia." (TCE- The Chemical Engineer, 1 December 2010)

From the Back Cover

A real–world guide to the production and manufacturing of biopharmaceuticals

While much has been written about the science of biopharmaceuticals, there is a need for practical, up–to–date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging.

Written by a group of experts from industry and academia, the book focuses on real–world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes:

• Research and early development phase appropriate approaches for ensuring product stability

• Development of commercially viable formulations for liquid and lyophilized dosage forms

• Optimal storage, packaging, and shipping methods

• Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions

• Useful analysis of successful and failed products

Formulation and Process Development Strategies for Manufacturing Biopharma–ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.

Edition details

• Publisher: Wiley
• Publication date: 2010
• ISBN 10: 0470118121
• ISBN 13: 9780470118122
• Binding: Hardcover
• Language: English
• Edition number: 1
• Number of pages: 984
• Editor: Jameel Feroz, Hershenson Susan