BPI Contributor

October 20, 2016

20 Min View
Reveal Information That Gives Insights: New Approaches to Sub-Visible Particle Characterization

Date: Oct 20, 2016

Duration: 20 Min

MiniTEM-aggregates-300x300.jpgThis webcast features: Josefina Nilsson, Head of EM Services,  and, Gustaf Kylberg, Product Manager – MiniTEM, Vironova

Sub-visible particle characterization is essential when comparing sample quality after different purification steps or for the understanding of product stability. Analysis performed with MiniTEM provides both morphology and accurate quantitative data that can help speed up process and formulation development.

In this webinar you will learn:

  • How MiniTEM automatically images, detects and classifies a large number of particles resulting in statistically significant and reproducible data

  • How a metric for sample purity based on the ratio of the total area of debris to that of intact Adenovirus particles is applied.

  • How analysis using MiniTEM saves about 65 hours compared with manual operation.

The purity of two different Adenovirus samples were compared and analyzed. Automated image acquisition and particle classification was performed using MiniTEM™ -a compact, low voltage transmission electron microscope. The combination of visual proof and metric values is not achievable from indirect methods like dynamic light scattering, nor is it feasible with conventional EM due to the very long hours of manual work required. With MiniTEM, therefore, process operators can rapidly and reliably compare samples from different purification steps and gain valuable insights into the stability of different product formulations.

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