Micro-Flow Imaging: Image-based Particle Analysis for Biopharmaceuticals
MFI™ gives you more insight into the world of sub-visible particles—way more than just size and count. Because it's image-based, you can add quantifiable morphological parameters to your analysis. You'll be differentiating particle populations from each other and classifying them in no time. Plus, it's got an optic focal length that spans the entire fluidic path, so your sample data is robust and reproducible day in and day out. Add a Bot1 anytime to automate the whole process and kick your throughput up a notch. If you're looking for broader, deeper analysis of your biotherapeutic products, MFI is the particle analysis tool for you.
Sub-visible particle analysis
See particles and protein aggregates for the first time with MFI. Lately, regulatory agencies have been focusing on sub-visible particles because of the risk they pose to patient safety. See how MFI's accurate reporting of particle size, shape and concentration can help you address these new regulatory requirements. Washing, rinsing, and sampling are automated allowing for overnight runs and repeatability.
How Can MFI 5000 Series Help You?
I need to measure translucent protein aggregates in my sample
Sensitive Detection for Biopharmaceuticals: Protein aggregates can be tough to measure but are important indicators of a pharmaceutical's stability. By obtaining the highest data quality on the size and count of sub-visible particles in your sample MFI provides you with the most accurate picture of protein aggregation in your sample.
I need rapid and robust sample analysis
Automation for Biotherapeutic Development: Bot1 gives you the throughput to develop your pharmaceutical formulation or manufacturing process fast and efficiently. In a single run Bot1 can handle up to 90 samples without manual intervention. Rated for up to 20 centipoise of viscosity MFI and Bot1 can handle the tough demands of modern biopharmaceutical formulations; giving you the analytical power you need to bring your product to market.
I need software that enables my work
Software Solutions to Empower Your Users: MFI software gives you the ability to dive deep into a single sample or examine a whole cohort at once. The MFI software suite offers a set of tools designed to give maximum analytical power with a user-friendly interface. Operating in a regulated environment? MFI software has everything you need to be 21 CFR Part 11 compliant.
Citations for MFI 5000 Series
View all citations for the Micro-flow Imaging (MFI) platform.
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Testimonials from your Peers for Micro-flow Imaging (MFI)
"As a biosimilar company, we investigate whether our products are similar to reference material, and use the MFI to perform comparability and stability. We must test samples from a variety of sources... for all these samples, we chose the automated MFI with Bot1 because a manual-only system just wouldn't have enough throughput."
Yuhwa's Biosimilars Analysis is a Slam-dunk with Micro-Flow Imaging + Bot1
Yuhwa Lee, Research Engineer, Samsung Bioepis
"We’re able to do extended analysis with images provided by MFI and then bridge this data with other techniques to identify and rapidly classify particles in solution. This helps our clients understand their products better and ensure they are providing the highest quality product to their patients."
Amber Raises the Bar on Product Quality with Micro-Flow Imaging (MFI)
Amber Fradkin, Ph.D., Associate Director, Particle Characterization Core Facility, KBI Biopharma
"MFI technology has allowed us to better understand what conditions promote stability of our therapeutic molecules, which ensures that only world-class medicines are delivered to patients."
Stephanie Davies, Ph.D., Formulation Sciences, MedImmune
More Information About MFI 5000 Series
How does MFI work?
Micro-Flow Imaging™ combines the direct imaging capabilities of digital microscopy with the precise control of microfluidics. What does that get you? High resolution images with 85% sampling efficiency, more precise counts and sizing with full morphological detail for all sub-visible particles in your sample and the complete confidence that you can accurately identify every possible type—from protein aggregates to air bubbles.
Images of the sample are captured as it passes through the flow cell's sensing zone. Every particle in every image is then analyzed to create a database of particle count, size, transparency and morphology (or shape). And you'll have visual verification on the spot, as images are displayed in real-time. You can also display the results for many samples at once, which makes it easy to monitor stability and comparability.
| Description | MFI 5100 | MFI 5200 |
|---|---|---|
| Size Range | 2 to 300 µm | 1 to 70 µm |
| Percent of Sample Analyzed | >85% — entire size range | >85% — entire size range |
| Depth of Field (DOF) | 400 µm | 100 µm |
| Flow Cell Depth | 400 µm — DOF matched | 100 µm — DOF matched |
| Analysis Rate | 200 µL/min | 150 µL/min |
| Maximum Concentration (@2.5 µm) | 175,000 particles/mL | 900,000 particles/mL |
| Automation | High Throughput Bot1 Autosampler (optional) | |
| Sample Loading Options | Pipette tip: 1 mL manual insertion, 1 mL Autosampler Syringe barrel 2 mL, 10 mL, 20 mL manual insertion BD Hypak™ Syringe Introduction Adapter: 1 mL, 2 mL | |
| Flow Cell Coatings | Non-coated, hydrophobic, custom | |
| Precision Stirring | Variable speed control: 200-2,000 RPM Compatible with syringe barrel usage | |
| Data Output | Chart formats: histograms, scatterplots, trend charts Image formats: uncompressed TIFF(analysis), compressed JPG(storage) | |
| Particle Count Parameters | Particle count, concentration, mass, volume | |
| Morphology Parameters | Size (ECD), maximum feret diameter, aspect ratio, circularity, area, perimeter, intensity | |
| Customized Analysis Filters | Combine two or more image and count parameters in a filter, for up to 511 different custom analysis filters | |
| MFI View System Software (MVSS) See product brochure for full details | Method-based analysis protocols Time - resolved analysis and data compression for storage 21 CFR Part 11 enabling features Secure access with comprehensive audit / log files Fully compatible with MFI View Analysis Suite(MVAS) | |
| MFI View Analysis Suite (MVAS) See product brochure for full details | Review images, parametric data and trend charts Isolate sub - populations using find - similar function Create multi - node filters with real - time feedback Overlay and compare data sets Generate comprehensive reports with multiple categories Create analysis templates for repeat use | |
| Dimensions | MFI 5000 Alone: 23.97 in W X 17.01 in D X 12.00 in H With Bot1 Autosampler: 23.97 in W X 17.01 in D X 26.20 in H | |
Product Documents for MFI 5000 Series
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