Product characterisation by High-Resolution Mass Spectrometry (HRMS)
In an industry where innovation often outpaces regulation, the ability to generate clear, reliable analytical data is more than a necessity, it’s a strategic advantage. At Quality Assistance, we deliver cutting-edge High-Resolution Mass Spectrometry (HRMS) solutions to support the characterisation of a wide range of therapeutic modalities. These include New Chemical Entities (NCEs) such as peptides and oligonucleotides, biotherapeutics like monoclonal antibodies and antibody-drug conjugates, as well as emerging drug platforms including mRNA and viral vectors.
Our workflows are fully GMP-compliant and designed to support every step of your analytical process, from early development to QC release.
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 oligonucleotide 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
- Identity and structure identification of impurities
From Technology to Expertise: Our HRMS platform
Cutting-edge infrastructure for reliable data
At Quality Assistance, we invest continuously to offer you access to cutting-edge HRMS technology within a fully GMP-compliant environment. Our infrastructure to support your projects include 5 High-Resolution Mass Spectrometers:
- 1 Waters BioAccord high-resolution mass spectrometer with a RDa Detector
- 3 Waters Xevo G2-XS QTOF high-resolution mass spectrometers with three dedicated H-class Bio and one 2D-LC UPLCs
- 1 MALDI-TOF autoflex Max, time-of-flight mass spectrometer
All systems are fully integrated into our GMP framework to deliver traceable, high-quality data.
A dedicated team of Specialists
At Quality Assistance, High-Resolution Mass Spectrometry platform is more than just advanced equipment, it’s the expertise of dedicated specialists who bring guidance, insight and precision at every stage of your project. They will work together with you to tackle the most complex analytical challenges, acting like real problem-solver, to help you from early development to late-stage QC release. At Quality Assistance, HRMS is not just about technology. It’s about people committed to your molecule’s success.
But at Quality Assistance, you're not just supported by a team of experts in the lab. You also benefit from the guidance of our in-house scientific advisors. They’re here to help you define the right strategy for the characterisation of your product, taking into consideration its development stage and relevant regulatory requirement. Their role is to make sure every step of your project is scientifically sound and aligned with your goals.
Case Studies
Biotherapeutics - Monoclonal Antibodies & ADCs
- Humira® (Adalimumab) - Advanced peptide mapping and glycosylation profiling
- Kadcyla® & Adcetris® - HRMS workflow for ADC structural characterisation
- Enbrel® (Etanercept) - N- and O-linked glycosylation profiling
mRNA
- 5' Cap and Poly(A) Tail Quantification - Multi-attribute analysis of mRNA drug substances and products
- Therapeutic mRNA Sequencing - Development of an innovative approach using new enzymes and advanced bioinformatics workflows
Advanced Analytical Methods
- Charge Variants characetrisation - Innovative combination of icIEF fractionation (Maurice Flex) + HRMS instruments
- MAM Implementation - Multi-attribute monitoring of mAbs under GMP constraints