Subvisible particles (SVP) are a critical quality attribute (CQA) for protein therapeutics that can limit a product’s shelf-life and induce immunogenicity. In this Halo University lecture, we present a pathway to validating the Aura platform for USP sub-visible particle counting. Combining Backgrounded Membrane Imaging (BMI) for total particle analysis with Side Illumination Membrane Imaging (SIMI) for external contaminants, including plastics, glass, and metals; enables the accurate determination of particles to support your USP 788 and 787 compliance requirements. Here, we focus on these techniques to help validate the Aura® platform, providing useful insights into determining the instrument, user, and sampling variability, and key criteria to define reproducibility of results.
Key Learning Objectives:
- Define the key USP criteria for SVP particle analysis
- Differentiation of particle sub-species in complex mixtures using BMI and SIMI, including data filtering using expression analysis
- Approaches to determine the accuracy and reproducibility of counting, sizing and operator performance
About the speaker:
Paul Dyer obtained his PhD in Cell Biology and Drug Delivery Strategies from the University of Greenwich. Following a period in academic research, Paul joined Halo Labs as an application scientist covering UK and Europe. Building upon his extensive background in medical science, he has been focusing on the development of new applications of particle analysis within the area of biologics, in particular cell therapies, resulting in the release of a new product, the Aura® CL.
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