Shedding light on surfactants used as excipient for biologics

May 7, 2024 – 4pm (CET) / 10am (ET)

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Shedding light on surfactants used as excipient for biologics

May 7, 2024 – 4pm (CET) / 10am (ET)

Addressed Challenges

  • Which method should be applied for surfactant characterization in which phase of development?
  • How to change from complex offline sample preparation protocols towards a fast Online sample preparation for surfactant analysis in biologics?
  • How to apply a novel universal characterization method for polysorbates and poloxamer?
  • Provide extensive insight into route-cause analysis of polysorbate degradation in biologics.

Learning Objectives

  • Understanding the importance of surfactant stability for the successful development of biopharmaceutical drug products.
  • Present a phase-appropriate analytical strategy for surfactant characterization in biologics.
  • Application of multidimensional liquid chromatography for surfactant analysis, combining online protein removal with a universal method suitable for polysorbates and poloxamers.

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.
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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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