Comparability Study of Manual and Automated Particle Characterization with MFI

The application note examines how a comparability study was conducted to assess manual and automated particle characterization with Multi-Flow Imaging (MFI), addressing the need for higher throughput and standardization in biopharmaceutical testing.

Key Points

• Micro-Flow Imaging (MFI) is increasingly used for particle analysis in protein formulations due to its ability to detect size and morphology of various contaminants.
• The study demonstrates the process of transferring a manual protocol to an automated format with the MFI 5000 series and Bot1 autosampler.
• Results show no statistically significant differences between manual and automated runs, confirming the comparability of both methods in particle characterization.