Description

Book Synopsis


Table of Contents
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

Surfactants in Biopharmaceutical Development

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A Paperback by Atanas V. Koulov, Satish K Singh

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    View other formats and editions of Surfactants in Biopharmaceutical Development by Atanas V. Koulov

    Publisher: Elsevier Science
    Publication Date: 8/15/2023 12:00:00 AM
    ISBN13: 9780128125038, 978-0128125038
    ISBN10: 0128125039
    Also in:
    Pharmacology Technology, Engineering & Agriculture Pharmaceutical chemistry and technology

    Description

    Book Synopsis


    Table of Contents
    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

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