Webinar: Practical Considerations for the Implementation of Subvisible Particle Characterization in Biotherapeutic Research and Development
Subvisible particle formation has become a key attribute that needs to be measured, monitored and characterized during the development of a protein biotherapeutic. As subvisible particle detection is still a relatively recent addition to the analytical toolbox, it is being deployed into many areas of research and development simultaneously, each with their own obstacles and challenges. This talk will focus on the advantages and practical considerations that must be accounted for when implementing subvisible particle detection, specifically using the ProteinSimple Micro-Flow Imaging (MFI) system, into biotherapeutic development. Topics covered will include employing the MFI to gain a better mechanistic understanding of subvisible particle formation, advanced data analysis to obtain quantitative measurements other than particle concentrations to assess product quality, implementing subvisible particle monitoring during formulation screening studies and assessing the risk posed by subvisible particles as a function of the route of administration.
Robert Simler, Ph.D., Senior Scientist, Genzyme – A Sanofi Company