MFI 5000 Series
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 Help You?
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.
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.
Compliant Easy-to-use Software Solutions
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.
Instrument 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 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
| MFI Brochure | Datasheet | User Manual |
| MFI Image Analysis Software Manual | Quick Start Guide |
Product Resources
| Access MFI training modules on Bio-Techne Academy | Software Downloads |
Yuhwa Lee, Research Engineer, Samsung Bioepis
"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
Amber Fradkin, Ph.D., Associate Director, Particle Characterization Core Facility, KBI Biopharma
"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)
Stephanie Davies, Ph.D., Formulation Sciences, MedImmune
"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."