Dynamic Imaging Particle Analysis (DIPA) of very small (sub-visible) particulates has become very important in the field of protein therapeutics.
The FlowCam Biologics from Meritics is an instrument based on their reliable and innovative FlowCam VS-Series that has been optimised for this very purpose. Volumetric-based particle analysis techniques, like light obscuration and laser diffraction assume that particles are spheres. They do not provide shape information.
The FlowCam Biologics, however, is able to distinguish between protein aggregates and silicon droplets, even in the 2μm to 10μm size range, because it recognises the real shape of the particle and doesn’t make assumptions. This makes the FlowCam Biologics the perfect instrument for:
- stability studies
- shelf-life simulation
- formulation research and development
- detection and measurement of protein aggregates
- detection and measurement of other sub-visible particulates
The FlowCam Biologics produces industry-leading quality images because Meritics understands that better measurements rely on better images and so that’s what they produce. The FlowCam also has higher sensitivity, which prevents the under counting of transparent particles and fractionation of larger protein aggregates.
It also permits automated, statistically-based pattern recognition, meaning that time is saved thanks to the isolation of different types of particle (aggregates, silicone oil droplets, etc) into categories and sub-populations.
The FlowCam Biologics comes ready-to-use with all you require to make the most of everything DIPA has to offer. It has pre-built filters for <788> reporting and silicone droplet isolation, 21CFR software, installation/training (including IQ/OQ) disposable pipette-tip sample introduction and with all system settings already optimised for Biologics.
If you’re not already convinced that FlowCam Biologics is the total system for the characterisation of sub-visible particulates in biological samples, why not request a free sample analysis? In return you will receive an online interactive presentation of the results, with digital images of cells and particles.
Alongside that you’ll find histograms and scattergrams representing size and distribution of sample particles and an Exel spreadsheet to give all the measurement data, including counts, lengths, widths and ESD; very impressive indeed.
For more details or to request a demo or a call back, please complete the Contact form below