Product characterisation by High-Resolution Mass Spectrometry (HRMS)
Quality Asssistance provides a wide range of technologies to fully characterise therapeutic proteins.
Whether you are interested in monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), fusion proteins, small or large proteins, Quality Assistance has the tools to support you for the characterisation of drug substances and drug products, QC and stability studies.
Comprehensive GxP-compliant product characterisation by HRMS
Recombinant proteins, mABs and ADCs
- Identity at the intact, subunit and peptide levels
- MS/MS peptide mapping sequencing and Multi-Attribute Monitoring of PTMs
- N- and O-glycosylation profiling
- Drug-to-antibody ratio and drug conjugation sites of ADCs
mRNA
- Identity by oligonucleotides mapping
- Capping efficiency
- Poly A tail size and distribution
AAV
- Identity of VP proteins at the intact level
- Identity by peptide mapping, including PTMs
Peptides
- Identity by intact mass and MS/MS sequencing
- Impurities identification by MS/MS
Oligonucleotides
- Identity at the intact level
- Sequencing
NCE
- Identification
Going further with your proteins
Quality Assistance strives to provide its customers with tools to better understand analytical results. We offer two-dimensional LC/MS analysis to further analyse charge variants, fragments and aggregates, and ADCs isomery. Read more on our article featured in Current Trends in Mass Spectrometry.
Quality Assistance offers state-of-the art hydrogen-deuterium exchange (HDX) analysis to learn more about proteins structures, stability and binding (epitope mapping).
Quality Assistance offers you dedicated analysts and equipment
- 3 Waters Xevo G2-XS QTOF high-resolution mass spectrometers with three dedicated H-class Bio and one 2D-LC UPLCs for protein characterisation
- An automated Waters HDX-2 hydrogen-deuterium exchange system
- 1 Waters BioAccord mass spectrometer with a dedicaded I-Class UPLC
- A Bruker AmaZon ion-trap mass spectrometer with ETD capabilities
- An Autoflex MaX MALDI-TOF/TOF mass spectrometer
- 5 specialised, highly skilled scientists at the bench
- Expert advice to determine a strategy that best suits your needs