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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.