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Development of safe and effective protein therapeutics relies on the accurate assessment of the amount, type, and size distribution of particle impurities within the formulation. Precise characterization of particles between 1–10 μm is increasingly in demand due to potential immunogenicity or loss of potency. However, observations at this size range have tested the limits of established analytical methods. One particular challenge has been the accurate discrimination of aggregated protein particles from silicone oil droplets, which form during drug storage in siliconized syringes.

While there are various ways to characterize particles in this size range, imaging flow cytometry offers some unique advantages in convenience of a platform technology. Imaging flow cytometry simultaneously collects fluorescent, bright-field, and side-scatter imagery for each particle in suspension, allowing particles to be identified using specific fluorescent stains and/or morphological properties. In this webinar, you will learn how certain imaging flow cytometry techniques can facilitate detection and classification of sub-10 μm protein aggregates and silicone oil droplets.

David B. Volkin, Ph.D., from the School of Pharmacy at the University of Kansas, will discuss the use of micro-flow imaging analysis as a tool to improve the identification of protein aggregates and microparticle detection.

Christine Probst, M.S., application scientist at Amnis Corporation, part of EMD Millipore, will provide an overview of imaging flow cytometry technology and will describe the development of a simple staining approach to fluorescently label protein aggregates and silicone oil droplets. Additionally, she will present data evaluating the Amnis® brand ImageStream®X and FlowSight® imaging flow cytometer performance for characterization of these particles, from which it will be demonstrated that the combination of fluorescence staining and imaging flow cytometry analysis greatly improves the specificity and sensitivity of protein aggregate and silicone oil detection.

Who Should Attend

  • Flow cytometrists
  • Biopharmaceutical protein development scientists
  • QC/QA scientists
  • Protein analytical scientists

You Will Learn

  • Concepts behind microflow imaging solution measurements and particle detection.
  • The conceptual differences between imaging flow cytometry and the current methods used for particle analysis.
  • Techniques for interpretation of Amnis imaging flow cytometry data to evaluate particle size distribution, and to determine the identity of particles within a sample.
  • Practical tips for successfully performing a bioformulation particle analysis assay with ImageStream®X and FlowSight® instruments.

Produced with support from:

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David B. Volkin, Ph.D.
Distinguished Professor,
University of Kansas

Christine Probst,
Application Scientist,
Amnis Corporation — Part of EMD Millipore