- 320 pages
- English
- ePUB (mobile friendly)
- Available on iOS & Android
eBook - ePub
Surfactants in Biopharmaceutical Development
About this book
Surfactants in Biopharmaceutical Development addresses the progress, challenges and opportunities for surfactant research specific to pharmaceutical development, providing a broad range of important surfactant-related topics as they relate directly to the biopharmaceutical process. Chapters address fundamental topics, like mechanisms of protein stabilization by surfactants, the latest, state-of-the-art technology and methods to illustrate the practical application to biopharmaceutical development, forward-looking chapters on control strategies and novel surfactants, with a special focus on current regulatory aspects of paramount importance for biopharmaceutical companies and regulators.
It has been widely recognized that surfactants provide protection to therapeutic proteins against interfacial stresses. Despite the fact that the very mechanism of protein stabilization by surfactants has not been completely understood, surfactants are universally regarded as critical functional excipients by the industry and by regulators.
- Describes the current state of research on surfactants in the context of biopharmaceutical development, drawing upon contributions from international experts across industry, academia, and regulators
- Addresses the opportunities and challenges associated with surfactants in biologic drug development
- Provides a defining resource for practitioners in the biopharmaceutical industry, regulators and academics by summarizing the latest knowledge of surfactants in biopharmaceutical development in one comprehensive volume
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Please note we cannot support devices running on iOS 13 and Android 7 or earlier. Learn more about using the app.
Yes, you can access Surfactants in Biopharmaceutical Development by Atanas V. Koulov,Satish K Singh in PDF and/or ePUB format, as well as other popular books in Medicine & Biotechnology in Medicine. We have over one million books available in our catalogue for you to explore.
Information
Table of contents
- Title of Book
- Cover image
- Title page
- Table of Contents
- Copyright
- Dedication
- Contributors
- Chapter 1 Introduction: Surfactants continue to surprise
- Chapter 2 Polysorbate in biopharmaceuticalsāan overview including in vivo fate and safety perspective
- Chapter 3 Surfactants (polysorbate and poloxamer): synthesis, characterization, and degradation
- Chapter 4 Mechanisms of stabilization of proteins by surfactants
- Chapter 5 Behavior of surfactants during processing
- Chapter 6 Analytical methods for surfactant characterization in biologic drug products
- Chapter 7 Oxidative degradation of surfactants: mechanisms
- Chapter 8 Hydrolytic degradation of surfactants and impact on protein stabilization
- Chapter 9 Scientific and regulatory considerations for developing protein formulations containing surfactants
- Chapter 10 Control strategies to address surfactant degradation: a quality perspective
- Chapter 11 A look to the futureāclosing remarks
- Author index
- Subject index