Surfactants in Biopharmaceutical Development
Published on 15. August 2023
Book
Paperback/Softback
234 pages
978-0-12-812503-8 (ISBN)
Description
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.
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.
More details
Language
English
Place of publication
San Diego
United States
Publishing group
Elsevier Science Publishing Co Inc
Target group
Professional and scholarly
Biopharmaceutical industry professionals working in drug development and pharmaceutical analysis, industry regulators and academics
Dimensions
Height: 231 mm
Width: 189 mm
Thickness: 12 mm
Weight
508 gr
ISBN-13
978-0-12-812503-8 (9780128125038)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Classification
Other editions
Additional editions
Atanas V. Koulov | Satish K. Singh
Surfactants in Biopharmaceutical Development
E-Book
08/2023
Academic Press
€155.00
Available for download
Persons
Atanas V. Koulov is the Head of Analytical Development and Quality Control, Drug Product Services at Lonza in Switzerland. His scientific career has focused on surfactants as protective excipients and includes eight years of work in the biopharmaceutical industry. Dr. Koulov's research is primarily concerned with understanding and preventing aggregation, as well as measuring and characterizing undesired byproducts of surfactant degradation. Dr. Koulov has co-organized and participated in symposia and conference sessions dedicated to surfactants. He has published extensively in the field of protein aggregation and particles and is the immediate past chair of the American Association of Pharmaceutical Scientists Protein Aggregation & Biological Consequences Focus Group. Satish K. Singh has more than 25 years of experience in biopharmaceutical product development. His expertise includes process development, scale-up and technology transfer and ranges from discovery support to development, manufacture and final drug product commercialization.Prior to joining Lonza, Satish was a Research Fellow and Group Leader in Pfizer's Biotherapeutics Pharmaceutical Sciences R&D Unit. Satish has also lead technical teams that focused on particulates, drug substance storage, antibody drug conjugate structure/property relationship, immunogenicity risk evaluation, and the development and application of computational tools in the chemistry, manufacturing and controls (CMC) aspects of biotherapeutics.
Satish holds a Ph.D. and MS in Chemical Engineering from Kansas State University and a B.Tech. in Chemical Engineering from the Indian Institute of Technology, New Delhi, India. He has published more than 70 scientific publications on various topics related to the field and is also an Adjunct Professor in the Department of Physical Pharmaceutical Chemistry, BMC, Uppsala University, Sweden. In 2017, Satish was elected an American Association of Pharmaceutical Scientists(AAPS) Fellow in recognition of his contributions to AAPS and drug product development.
Satish holds a Ph.D. and MS in Chemical Engineering from Kansas State University and a B.Tech. in Chemical Engineering from the Indian Institute of Technology, New Delhi, India. He has published more than 70 scientific publications on various topics related to the field and is also an Adjunct Professor in the Department of Physical Pharmaceutical Chemistry, BMC, Uppsala University, Sweden. In 2017, Satish was elected an American Association of Pharmaceutical Scientists(AAPS) Fellow in recognition of his contributions to AAPS and drug product development.
Content
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
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