Is your particle analysis method giving you the full picture of your product? Do you need to detect translucent protein aggregates in your sample? Introduce particle morphology to your analysis with Micro-Flow Imaging (MFI®).
MFI is your particle analysis problem solver. With an image-based approach that allows quantifiable morphological characteristics to be derived from a particle image, MFI is able to provide deeper insight into the nature of your particles. Measuring small and potentially translucent protein aggregates with MFI gives you early insight into the efficacy and safety of a formulation, as well as the long-term stability of your product.
Gain More Insight?
- Translucent particle detection
- Full morphological detail
- Reduce recall risk
MFI Sees Translucent Particles LO Misses
Compendial methods like Light Obscuration (LO) don’t give you complete profiles due to gaps in their analysis, creating more risk during QC or when you need to file New Drug Applications (NDAs). MFI’s combination of sensitivity and morphological information makes it a crucial tool in the effort to more fully characterize particles and protein aggregates in biopharmaceuticals. It also gives you a deeper level of insight when it comes to sub-visible particle analysis compared to LO because of its ability to detect highly translucent protein particles and distinguish them from intrinsic and extrinsic contaminants. In fact, MFI gives you the sub-visible particle data requested in FDA letters and immunogenicity guidelines.
Read our white paper to learn about the differences between MFI and LO, and how MFI can improve your particle analysis.
How does MFI work?
MFI combines the direct imaging capabilities of digital microscopy with the precise control of microfluidics to classify proteins and non-protein particles. That gives you direct, image-based detection of size, count and shape for sub-visible particles between 1-300 microns in solution. Watch the video to learn how MFI can give you accurate quantitation of translucent protein particles, so you can get a clear understanding of your protein formulation.
If you're curious about pricing, just send us your request.