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, drawing upon contributions from international experts across industry and academiaAddresses the opportunities and challenges associated with surfactants in drug development and deliveryProvides a defining resource for practitioners in the biopharmaceutical industry, regulators and academicsSummarizes the latest knowledge of surfactants in biopharmaceutical development in one comprehensive volume INDICE: 1. Introduction 2. Surfactants used in biopharmaceutics today: an overview (including in vivo fate and a 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. Oxidative surfactant degradation and impact on protein stabilization 9. Hydrolytic degradation of surfactants and impact on protein stabilization 10. Regulatory Perspective on Surfactant Monitoring and Control 11. Control strategies to address surfactant degradation: a quality perspective 12. Surfactants in biotechnnology: a look to the future
- ISBN: 978-0-12-812503-8
- Editorial: Academic Press
- Encuadernacion: Rústica
- Páginas: 320
- Fecha Publicación: 01/10/2018
- Nº Volúmenes: 1
- Idioma: Inglés