First Across the Finish Line: QC Product Release
Getting your therapeutic across the finish line is all about meeting critical quality attributes (CQAs). And when the world is waiting for your therapeutic, there’s no time for your workflow to slow you down. From impurity screening to charge variant analysis and aggregate identification, our robust, automated and 21 CFR Part 11-compliant analytical platforms will get your therapeutic protein to patient - fast.
If you’re tired of lengthy method optimization for each protein but need charge variant analysis for your final QCs, discover our platform methods!
Meet Maurice and iCE3, your platform method IEX replacement for charge heterogeneity analysis:
- Fast: You’ll have results in just 10 minutes per sample and with parallel analysis of up to 96 samples and the resolution you need to quantitate CQAs
- Consistent and robust: simple workflows, high resolution, and automation cut the variability
- Tackle difficult proteins: easily resolve antibody drug conjugates and fusion proteins
- Flexible: Need CE-SDS analysis? No problem! Maurice does it all.
- Compliant: The Maurice Empower® Control Kit lets you control Maurice with Empower® 3 software while maintaining 21 CFR Part 11 compliance. Still want to use Compass for iCE software? Our latest embedded software allows you to use both.
CE-SDS for Product and Process Impurities
Are drifting baselines, tedious workflows, complicated analysis and limited throughputs thoughts that come to mind when considering traditional CE-SDS workflows?
It’s time to think again.
CE-SDS on Maurice™ isn’t the usual tedious and complicated routine. All it takes is a simple, 10-minute setup and up to 48 samples are processed – automatically. He gives you protein purity plus site occupancy and also detects low abundance clips with a baseline that’s more likely to stay put—so your quantitation’s better too.
Maurice gives you a CE-SDS profile with the ability to track proteins and contaminants including:
- Combinations of light and heavy chain antibody fragments
- Non-specific cleavage products
- Non-dissociable HMW aggregates.
- Host cell proteins
Simple Solutions for Contaminant Screening
Whether you need to screen for host cell proteins or process residuals, discover our easy, automated, Simple Western and Simple Plex solutions for confidence in the purity of your final product.
While standard sandwich ELISA doesn’t provide molecular weight (MW) information and manual Western blotting is labor intensive and qualitative in nature, Simple Western gives you the specificity to detect co-migrating proteins, report molecular weight, and automate bioprocess contaminant analysis!
Making The Invisible, Visible
If light obscuration (LO) misses your aggregates, MFI is right on target. Get the size, count, and shape of subvisible particles in the 1 μm to 300 μm range. Discriminate between proteinaceous and non-protein particles - like silicon oil and protein aggregates in your samples – with MFI’s image-based detection combined with 21CFR Part 11 compliant software.
Confident QC with Exosome Diagnostics
Do your QC regulations include functionality and media analysis? Get the answers straight from your cell media – with exosome analysis from Exosome Diagnostics.
Discover how Exosome Diagnostics can improve your protein, DNA and RNA analysis.