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.
Giới thiệu về tác giả
Feroz jameel, Ph D, is Principal Scientist for Drug Product
Process Development at Amgen, involved in the development of
biopharmaceutical products and the develop-ment of new technologies
to enhance drug product manufacturing. Dr. Jameel is the recipient
of the Parenteral Drug Association’s 1999 Fred Simon Award for the
Best Paper Published in the PDA Journal of Pharmaceutical Science
and Technology.
SUSAN HERSHENSON, Ph D, is Vice President for Pharmaceutical and
Device Development at Genentech. She has more than fifteen years’
experience in the area of formulation and delivery, including
development of protein and small molecule therapeutics.
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