Advanced characterisation of biotherapeutics with HRMS
13th January 2025
Advanced characterisation of biotherapeutics with HRMS
Empower your biotherapeutics development with cutting-edge LC-MS solutions tailored for precise evaluation of Critical Quality Attributes (CQAs)
Biotherapeutics, including monoclonal antibodies (mAbs) and therapeutic proteins, are at the forefront of modern medicines. Their production requires precise characterisation of critical quality attributes (CQAs) such as post-translational modifications (PTMs), structural integrity, and charge variants to ensure their efficacy, safety, and quality.
At Quality Assistance, we leverage advanced HRMS (High-Resolution Mass Spectrometry) technologies to provide tailored solutions. Our innovative workflows optimise biotherapeutics development, offering comprehensive, reproducible, and GMP-compliant analyses.
Recently developed applications
Comprehensive Multi-Attribute Monitoring (MAM)
Our HRMS-based MAM methodology ensures:
- Accurate quantification of CQAs such as deamidation, oxidation, glycosylation, and lysine clipping.
- Simultaneous analysis of multiple attributes in a single run, saving time and resources.
Case Study: Our interlaboratory study, published in Molecules, demonstrated exceptional reproducibility and robustness of MAM workflows across laboratories, highlighting their reliability for regulated environments.
icIEF fractionation for charge variant identification
We recently implemented a MauriceFlex system from Bio-Techne, in order to achieve identification of icIEF-separated charge variants.
- Routine icIEF methods developed on a Maurice instrument can be easily transferred to the MauriceFlex for fractionation.
- Collected fractions can be further anlaysed by MS, either for intact mass determination, or for more advanced characterisation with a peptide mapping approach.
Combination of MauriceFlex with state-of-the-art HRMS instruments allows for advanced characterisation of charge variants, as requested by regulatory authorities.
Why Partner with Quality Assistance for Biologics?
✅ Expertise in advanced analytical workflows for biologics characterisation.
✅ Cutting-edge technologies delivering accurate, reproducible, and GMP-compliant results.
✅ Proven track record in regulatory-compliant analyses for complex therapeutic proteins.