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Surfactants in Biopharmaceutical Development addresses the progress, challenges, and opportunities in surfactant research in the context of the development of biologic therapeutics. It has been widely recognized that surfactants provide protection to therapeutic proteins against interfacial stresses, which is the reason that nearly all therapeutic proteins in development and on the market today contain surfactants. 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 for biopharmaceuticals by the industry and by regulators. This book provides a broad range of important surfactant-related topics as they relate directly to biopharmaceutical development. The initial chapters of the book address fundamental topics, like synthesis of surfactants, mechanisms of protein stabilization by surfactants, as well as practical considerations for the use of surfactants in biomanufacturing. Later chapters provide overview of the state-of-the-art analytical technology and methods for quantification and characterization of surfactants, as well as a deep-dive in one of the hottest topics in biopharmaceutical development today - surfactant degradation and its impact to drug product quality and stability. The book concludes with forward-looking chapters on control strategies with a special focus on current regulatory aspects of paramount importance for biopharmaceutical companies and regulators.
1. Introduction 2. Polysorbate Surfactants used in biopharmaceuticals: An overview including in vivo fate and toxicology perspective 3. Surfactants (polysorbate and poloxamer) synthesis and degradation: Overview and relevance 4. Mechanisms of stabilization of proteins by surfactants 5. Behaviour of surfactant during processing (UF/DF, filter adsorption) 6. Analytical methods for surfactant characterization in Drug Product 7. Oxidative degradation of surfactants: Mechanisms 8. Hydrolytic degradation of surfactants and impact on protein stabilization 9. Regulatory Perspective on Surfactant Monitoring and Control 10. Control strategies to address surfactant degradation: A quality perspective 11. A look to the future - closing remarks
