For a list of peer-reviewed articles our products have been cited in, check out the publications page.
Please note that the general Technical Library page may contain additional product categories of interest.
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.
Robust and fast analytical techniques are critical for achieving commercial success of therapeutic biologics and achieving it first. Speed up the development process with iCE and MFI from ProteinSimple. These highly sensitive technologies will streamline each step in the biologics characterization and manufacturing process so that you can win the race to FDA approval.
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.
“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 Fradkin, Ph.D., Associate Director, Particle Characterization Core Facility, KBI Biopharma
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.