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.

MFI 5000

How Can MFI Help You?

I need to know more about the particles in my sample

Image Based Particle Differentiation

Pharmacopeial agencies are demanding more information on the nature of particles within a pharmaceutical product. Different particle populations present different risks and need different mitigation strategies. MFI can help you differentiate particle populations within your sample to give you insight into the pharmacopeial particle definitions that will support your NDA or regulatory filing.

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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.

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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.

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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.

Technology & Applications

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.

Specifications
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
  • 21CFR 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