Day :
- Developing Biosimilars & Biobetters| Challenges in Biosimilars | Regulatory Advances in Biosimilars | Protein Biotherapeutics and Biosimilars | Biopharmaceutical | Bioequivalence Assessment
Location: Rembrandt 2
Chair
Francois Xavier Frapaise
FX Frapaise Pharma Consulting, France
Session Introduction
Lydia Michaut
BioAgilytix, Switzerland
Title: Recommendations for the development and validation of neutralizing antibody assays in support of biosimilar assessment
Biography:
Lydia Michaut holds a Master’s degree in Molecular and Cellular Biology and PhD in Immunology from the University of Strasbourg (Laboratory of Jules A Hoffman, 2011 Nobel Prize for Physiology and Medicine with Bruce A Beutler and Ralph M Steinman for Innate Immunity). She then spent over ten years in research on Gene Expression and Genetic Control of Eye Development and Body Axis Formation at the University of Basel, and has ten years of experience in the Development of Biologics and Gene Therapy Drugs in a leading pharmaceutical company. She is also involved in several initiatives from the European Bioanalytical Forum (EBF) such as stability of anti-drug antibodies, management of critical reagents for ligand binding assays, and qPCR.
Abstract:
Biography:
Steven A Watt was granted with a position as Assistant Professor at the Department of Proteome and Metabolome Research after studying Molecular Biology at the Bielefeld University and graduating with a PhD in Genetics and Molecular Biology in 2005. There, he was In-charge of a Mass Spectrometry Service unit, dealing with proteome and metabolome projects. In 2009, he joined Thermo Fisher Scientiï¬ c as an Instructor for scientiï¬ c and pharmaceutical mass spectrometry applications. In his current position as a Business Development Manager at A&M STABTEST, he is involved in customer relations, marketing and the development of new analytical services in the ï¬ eld of pharmaceutical analysis.
Abstract:
Polysorbates (PS), namely PS 20 and PS 80, are widely used in formulations of therapeutic proteins to stabilize and protect these against adsorption, aggregation and precipitation induced by high protein concentration, interfacial or mechanical stress. However, recently there have been increasing reports of issues with PS containing biopharmaceutical drug products, these include clouding phenomena, particulate formation and protein oxidation. In all these cases, there is evidence that PSs or rather their degradation products may be the root cause. The analysis of PSs, due to their heterogeneity, is challenging and although there are robust methods available to quantify PS even in presence of proteins, more comprehensive approaches are required to characterize PS raw materials or monitor their stability throughout the product’s shelf-life. A deeper understanding of impurities and degradants present in PS raw materials and their degradation products arising during storage are essential to understand quality issues and to deï¬ ne control strategies on raw-material level or improve PS stability in the formulation. Here, we propose an LC-MS approach for characterization of PS raw material and a quantitative screening method for fatty acid degradation products in the ï¬ nal formulation. Furthermore, we want to give an outlook on ongoing investigations regarding the impact of packaging material components on PS stability.
- Special Panel Discussion
Location: Rembrandt 2
Chair
Francois Xavier Frapaise
FX Frapaise Pharma Consulting, France