For a list of peer-reviewed articles our products have been cited in, check out the publications page.
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Particulate contamination, including protein aggregates, can have an effect on drug safety and efficacy, and characterization of subvisible particles can be an indicator of product and formulation stability. In this App Note, we show how we use Micro-Flow Imaging to evaluate the stability of two therapeutic monoclonal antibodies, trastuzumab and bevacizumab, and their biosimilars.
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.
MFI Silane-Coated Flow Cell Cleaning and Care Technical Note
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.
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.
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.
MFI Image Analysis software is a new tool suite for analyzing the particle images you’ve captured with Micro-Flow Imaging (MFI). MFI Image Analysis software improves your workflows and gives you a new set of user interface options for analyzing all the data you get from your MFI 5000 series.
In this eBook, we examine technological advances in protein analysis that are at the forefront of immuno-oncology research and therapeutic development.
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.
“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’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.
Protein aggregation and the formation of subvisible particles can significantly impact the safety and efficacy of biopharmaceuticals. Therefore, protein aggregation and subvisible particle content must be carefully monitored during in-process and final product development. ProteinSimple offers Micro-Flow Imaging™ (MFI), a powerful system to analyze protein aggregates and other subvisible particles in your samples.
Prior to initial use, and after running samples, ProteinSimple recommends cleaning the MFI flow cell using the specific guidelines contained herein.
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.
In this white paper, we’ll highlight the differences between MFI and LO using published literature to help you learn more about how MFI can improve your particle analysis.