Markela Murphy, Dosage Form Design & Development, Biopharmaceuticals Development, R&D, AstraZeneca, Gaithersburg, US
Protein degradation via aggregation route is a common source of SVPs. Well-established methods for SVP analysis, such as light obscuration and microflow imaging, are not high-throughput and require significant amounts of sample volume. The focus of this work was to evaluate the backgrounded membrane imaging (BMI) for SVP analysis and identify critical experimental parameters. In conclusion, BMI can be used as a high-throughput method for qualitative particle analysis.