Shedding light on surfactants used as excipient for biologics

Polysorbate degradation mechanisms, surfactant characterisation strategies and multidimensional chromatography for surfactant analysis in biologics.

May 7, 2024

4pm (CET) / 10am (ET)

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OVERVIEW

In this engaging webinar, we will delve into the critical realm of surfactants, shedding light on their significance in formulation development for biologics and gene and cell therapy products. The main focus will be on the root-cause analysis of polysorbate degradation, unraveling the mysteries surrounding this common challenge in pharmaceutical formulations. We will furthermore explore the nuances of polysorbate and poloxamer characterization, focusing on presenting a novel approach to their isolation from typical drug product matrices.

Dr. Zegota will guide participants through the application of multidimensional liquid chromatography, emphasizing a robust methodology for online sample preparation and surfactant analysis. The aim is to provide attendees with an effective strategy and practical approach to improve the accuracy and efficiency of their analytical processes.

Prof. Schöneich will provide new insights into the role of free fatty acids for polysorbate stability, presenting cutting-edge research that goes beyond conventional understanding.

Participants can expect to broaden their knowledge base and gain a deeper understanding of polysorbate degradation. Whether you are an experienced researcher, a formulation scientist or a professional in the pharmaceutical field, this webinar is a unique opportunity to stay abreast of the latest advancements in surfactant analysis. Join us for an informative session that will not only highlight the challenges, but also provide practical solutions to improve your analytical practices and contribute to formulation success. Don’t miss this valuable opportunity to engage with experts and enhance your expertise in surfactant science.

Addressed Challenges

01Selecting the appropriate analytical method for surfactant characterisation at each phase of biologic drug product development and stability assessment.

02Transitioning from complex offline sample preparation protocols to faster online methods for surfactant analysis in biologic drug product matrices.

03Applying a universal characterisation method that works across both polysorbates and poloxamers without requiring separate dedicated analytical approaches.

04Conducting robust root-cause analysis of polysorbate degradation in biologics, including understanding the role of free fatty acids in instability pathways.

WHAT YOU WILL LEARN

01Understand the importance of surfactant stability and why robust analytical characterisation is essential for successful biopharmaceutical drug product development.

02Learn a phase-appropriate analytical strategy for surfactant characterisation in biologics that aligns with development stage and regulatory expectations.

03Explore the application of multidimensional liquid chromatography for surfactant analysis, combining online protein removal with a universal detection method.

04Gain new insights into polysorbate degradation mechanisms, including the role of free fatty acids and how to apply this knowledge to formulation strategy.

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SPEAKERS

Dr. Christian Schöneich

Professor and Chair, The University of Kansas

Dr. Schöneich is the Takeru Higuchi Distinguished Professor for Bioanalytical Chemistry and Chair of the Department of Pharmaceutical Chemistry at The University of Kansas. Between 1987 and 1991 he worked in the Department of Radiation Chemistry at the Hahn-Meitner Institute in Berlin, Germany, and received his Ph.D. in Chemistry in 1990 from the Technical University Berlin, Germany. He joined the Department of Pharmaceutical Chemistry at The University of Kansas as a post-doctoral fellow in 1991, and as a faculty member in 1992; in 2004, he was a Visiting Professor at the ETH Zürich, Switzerland. His research focuses on oxidation reactions of peptides, proteins, and surfactants. With respect to peptides and proteins, he studies oxidation reactions in vivo and in vitro, and their potential consequences for the development of stable protein pharmaceuticals, biological aging, and age- related pathologies. He has published over 290 papers in the field of peptide and protein oxidation reactions.

Dr. Maksymilian Żegota

Senior Scientist, Coriolis Pharma

Dr. Zegota earned his PH.D. in chemistry from the Max Planck Institute for polymer research in Mainz, Germany, concentrating on site-selective protein modification. After completing his doctorate, he joined Coriolis Pharma in Martinsried, Germany. Currently, he focuses on developing novel methods for surfactant analysis in biologics to assist in the root-cause analysis of polysorbate and poloxamer degradation, contributing to formulation development in the pharmaceutical field.

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