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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
1. Introduction2. Polysorbate Surfactants used in biopharmaceuticals: An overview including in vivo fate and toxicology perspective3. Surfactants (polysorbate and poloxamer) synthesis and degradation: Overview and relevance4. Mechanisms of stabilization of proteins by surfactants5. Behaviour of surfactant during processing (UF/DF, filter adsorption)6. Analytical methods for surfactant characterization in Drug Product7. Oxidative degradation of surfactants: Mechanisms8. Hydrolytic degradation of surfactants and impact on protein stabilization9. Regulatory Perspective on Surfactant Monitoring and Control10. Control strategies to address surfactant degradation: A quality perspective11. A look to the future - closing remarks
