Characterization of Subvisible Particles in Protein and Viral Vaccines


21st May 2019 | 10.00 am EST | Marina Kirkitadze,Head of Process Support & PAT Platform, Analytical Sciences at Sanofi Pasteur and Bonnie Edwards, Product Manager of Imaging and MFI at ProteinSimple |WATCH FOR FREE

The topic of this presentation is a 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.

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

Marina Kirkitadze is Head of Biophysics and Conformation Unit at Biochemistry Platform, Analytical R&D North America, Sanofi Pasteur Ltd., Toronto, Canada. She has 17 years’ experience in the vaccine industry. Marina received her PhD in Biological Sciences at the Institute of Protein Research, Russian Academy of Sciences, Pushchino, Russia, and her MBA from the University of Phoenix, AZ, USA. Marina’s main focus is a characterization of vaccine components, specifically, protein conformation and stability in solution and in adjuvanted form.

Sponsored by ProteinSimple

Bio-Techne is a global life sciences company providing innovative tools and bioactive reagents for research and clinical diagnostic communities. Bio-Techne’s product portfolio, representing the biomedical research brands of R&D Systems, Novus Biologicals, Tocris, ProteinSimple and ACD, assists scientific investigations into biological processes and the nature and progress of specific diseases. Additionally, Bio-Techne has announced an initiative to advance cell and gene therapy research and ex vivo cell processing as part of its mission of providing “Pioneering Cell and Gene Therapy Solutions from Discovery to the Clinic.”

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

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.

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

Bonnie Edwards is the Product Manager for Imaging and MFI at ProteinSimple, a Bio-Techne brand. She has a B.A. in Molecular and Cell Biology from UC Berkeley. Her background includes small molecule drug discovery, high-throughput screening, flow cytometry, and lab automation.


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