Surfactants in Biopharmaceutical Development

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Atanas V. Koulov (Head of Analytical Development and Quality Control, Drug Product Services, Lonza AG, Switzerland) Satish K Singh (Head, Drug Product Process Development, Drug Product Services, Lonza AG, Switzerland)

Surfactants in Biopharmaceutical Development

Atanas V. Koulov (Head of Analytical Development and Quality Control, Drug Product Services, Lonza AG, Switzerland), Satish K Singh (Head, Drug Product Process Development, Drug Product Services, Lonza AG, Switzerland)

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English

Academic Press Inc
25 August 2023

Pharmacology; Detergents technology; Pharmaceutical technology

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.

Edited by: Atanas V. Koulov (Head of Analytical Development and Quality Control Drug Product Services Lonza AG Switzerland), Satish K Singh (Head, Drug Product Process Development, Drug Product Services, Lonza AG, Switzerland)
Imprint: Academic Press Inc
Country of Publication: United States
Dimensions: Height: 235mm, Width: 191mm,
Weight: 450g
ISBN: 9780128125038
ISBN 10: 0128125039
Pages: 234
Publication Date: 25 August 2023
Audience: Professional and scholarly , Undergraduate
Format: Paperback
Publisher's Status: Active

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.