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Characterization of Subvisible Particles in Protein and Viral Vaccines

Presented by Marina Kirkitadze, Head of Process Support & PAT Platform, Analytical Sciences at Sanofi Pasteur

The topic of this presentation is characterisation of visible and subvisible particles in protein and viral vaccine formulations. Visible and subvisible particles were found to be inherent to the product, and were analyzed by several methods including MFI, DLS and PALS.

Followed by Characterizing Sub-Visible Particle Populations with Micro-Flow Imaging

Presented by Bonnie Edwards, Product Manager of Imaging and MFI at ProteinSimple

Accurate determination of sub-visible particles and protein aggregates is important to ensure safety and efficacy of biopharmaceutical formulations. As such, biopharmaceutical manufacturers are expected to characterize, monitor, and control sub-visible particles and protein aggregates in their products. Traditional techniques such as light obscuration often lack the sensitivity to distinguish translucent and potentially harmful protein aggregates. With imaging-based, direct particle detection, Micro-Flow Imaging (MFI) offers several advantages over traditional techniques, enabling the ability to detect and identify protein aggregates as well as other sub-visible contaminants. In this presentation, we will discuss how MFI provides particle count, size, and other morphological information in order to provide novel and unique insights into particle characterization and quantification in protein formulations.
Recorded May 21 2019 53 mins
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Presented by
Marina Kirkitadze,Head of Process Support at Sanofi Pasteur and Bonnie Edwards, Product Manager at Protein Simple
Presentation preview: Characterization of Subvisible Particles in Protein and Viral Vaccines
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  • Title: Characterization of Subvisible Particles in Protein and Viral Vaccines
  • Live at: May 21 2019 2:00 pm
  • Presented by: Marina Kirkitadze,Head of Process Support at Sanofi Pasteur and Bonnie Edwards, Product Manager at Protein Simple
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