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Surfactants in Biopharmaceutical Development
Surfactants in Biopharmaceutical Development
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Surfactants in Biopharmaceutical Development explores the progress, challenges, and opportunities in surfactant research for biologic therapeutics, highlighting their critical role in protein stabilization and biomanufacturing. It covers fundamental topics, analytical methods, and degradation, with a focus on regulatory aspects.
Format: Paperback / softback
Length: 234 pages
Publication date: 01 August 2023
Publisher: Elsevier Science Publishing Co Inc
Surfactants play a crucial role in the development of biopharmaceuticals, as they provide protection to therapeutic proteins against interfacial stresses. This book explores the progress, challenges, and opportunities in surfactant research in the context of biologic therapeutics. It highlights the importance of surfactants as critical functional excipients in biopharmaceuticals, with nearly all therapeutic proteins in development and on the market today containing surfactants. Despite the incomplete understanding of the protein stabilization mechanism by surfactants, they are universally regarded as essential by the industry and regulators.
The book covers a wide range of important surfactant-related topics, including synthesis, protein stabilization mechanisms, practical considerations for biomanufacturing, analytical technology, quantification, characterization, and surfactant degradation. It provides insights into the state-of-the-art analytical methods and techniques for studying surfactants. Additionally, the book delves into the topic of surfactant degradation and its impact on drug product quality and stability, which is a critical concern in biopharmaceutical development.
The book concludes with forward-looking chapters on control strategies, with a special focus on current regulatory aspects that are of paramount importance for biopharmaceutical companies and regulators. Overall, this book serves as a valuable resource for researchers, scientists, and professionals involved in biopharmaceutical development, providing comprehensive coverage of surfactant research and its applications.
Dimension: 235 x 191 (mm)
ISBN-13: 9780128125038
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