MFI technical library

Polystyrene beads are ideal for particle sizing and sensitivity testing because they easily trigger the MFI imaging detector, yielding consistent and precise sizing and concentration results over a large size range. To ensure correct usage, this application note discusses recommended guidelines on how to use bead calibration for sizing and concentration verification on the MFI 5000 series with or without the Bot1 autosampler.

All biological therapeutics have to be tested for many quality attributes like protein aggregation. And all these quality attributes need to be tested at many different product development stages including early formulation, purification, manufacturing and QC. Add all those attributes and stages together and that's a lot of testing. It also means your sample is pretty precious given you often only have a few mLs to use per test — and that limits your ability to run replicates too. So to help stretch your sample to max out the amount of data you can collect, we looked at ways the automated MFI + Bot1 could decrease the amount of sample you need to get particle information on a whole bunch of sample concentrations.

In this application note, we’ll show you how to get the same great data you’ve always gotten with MFI, just with less than 600 μL of plated material instead of the usual 1.6 mL you’d normally use.

In this application note, you’ll see how automation via image-based Micro-Flow Imaging™ (MFI) technology gets you the quantitative and morphological data you need to have confidence in distinguishing between beads, T cells or other potential contaminants.

In this application note, we’ll focus on the 21 CFR Part 11 tools integrated into MFI for method and batch execution, data processing
and audit trails.

This document supports the use of Micro-Flow Imaging® systems (MFI 5100, MFI 5200) in a QC and GMP environment. All functionality is integrated in MVSS (V5.0) for compliance with 21 CFR Part 11. The information presented assumes that the appropriate system configuration parameters have been set.

ProteinSimple’s analytical platforms give you the automation and scalability needed for the development and manufacturing of C> products, and with low volume requirements, we help you preserve these precious samples. Platform methods can be seamlessly transferred across labs and project phases, from discovery to manufacturing, giving you consistent results from start to finish.

Proteins are the heart and soul of functional biology and understanding proteins is central to understanding disease. However, proteins are difficult to interrogate because they are large, complex, and unique. Here at ProteinSimple, we believe that traditional protein analysis tools can be overly complex or inadequate, and our goal is to make protein analysis simpler, more quantitative, and affordable. Ultimately, we want to help researchers gain a better understanding of proteins and their role in disease.

“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

We want to keep you updated on all of our advances in protein discovery and analysis, so here is our quarterly newsletter. It's never been easier to see what we're up to because each page covers a product platform and, if you want to attend an event, all you have to do is click on it to register. From new application notes and publications to product updates, we've got you covered.

Concentration and morphologic distributions of particle sub-populations is required to ensure product quality of biopharmaceuticals. However, current pharmacopeial methods are not optimized for transparent protein aggregates which can lead to undercounting. MFI addresses this technology gap, combining sensitive image capture and morphologic analysis that can discriminate translucent protein particles from silicone micro-droplets and other particles.

Many features of protein-based pharmaceuticals limit the ability of standard particle analysis methods to characterize them. For example, high particle concentrations, heterogeneous particle types, viscosity, and a low refractive index are known to reduce the detection and sizing accuracy of light obscuration and membrane microscopy. As reviewed in this poster, Micro-Flow Imaging (MFI) technology can analyze many types of challenging protein samples using direct, imaging-based particle measurement. Particle types detected include semi-transparent protein fragments, air bubbles, and contaminants such as silicone oil micro-droplets. Moreover, MFI detection is largely independent of a particle's optical properties; thus it can handle concentrated antibody solutions, as well as viscous samples.

The National Institutes for Food and Drug Control in China conducted a first-of- its-kind, recently published study in which light obscuration and micro-flow imaging (MFI) methods were both used to analyze particulate matter in 17 commercial therapeutic monoclonal antibodies (mAbs). In this study, researchers found that detection with MFI provided a higher particle count than light obscuration overall, a crucial indication that certain contaminants can otherwise go undetected with compendial methods, thereby increasing the risk of adverse side-effects in patients. Contributing factors of higher particle counts with MFI were also discussed in this paper.

Prior to initial use, and after running samples, ProteinSimple recommends cleaning the MFI flow cell using the specific guidelines contained herein.

MFI Silane-Coated Flow Cell Cleaning and Care Technical Note

This user guide will walk you through the features and operation of the Image Analysis toolset of MFI View System Software (MVSS).

In this white paper, we highlight how researchers are leveraging MFI throughout the biomanufacturing process. From monitoring cell culture scale-up to formulation development and stability testing, MFI gives you robust and reproducible results, providing a deeper analysis of your biotherapeutic products.