Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

A real-world guide to the production and manufacturing ofbiopharmaceuticals
While much has been written about the science ofbiopharmaceuticals, there is a need for practical, up-to-dateinformation on key issues at all stages of developing andmanufacturing commercially viable biopharmaceutical drug products.This book helps fill the gap in the field, examining all areas ofbiopharmaceuticals manufacturing, from development and formulationto production and packaging.
Written by a group of experts from industry and academia, thebook focuses on real-world methods for maintaining productintegrity throughout the commercialization process, clearlyexplaining the fundamentals and essential pathways for alldevelopment stages. Coverage includes:
* Research and early development phase-appropriate approachesfor ensuring product stability
* Development of commercially viable formulations for liquid andlyophilized 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 ManufacturingBiopharma-ceuticals is an essential resource for scientists andengineers in the pharmaceutical and biotech industries, forgovernment and regulatory agencies, and for anyone with an interestin the latest developments in the field.