MS-Based Contaminant Detection
Workflow-based solutions enable flexible identification and quantification of product- and process-related contaminants—such as host cell proteins (HCPs) and polysorbate degradation products—delivering high-sensitivity while dramatically reducing the number of false-positive identifications.
Automated Monitoring. High Reproducibility.
In quality monitoring, high-throughput assays based on multiple reaction monitoring (MRM) are often applied as a fast, quantitative testing method. Genedata Expressionist® offers fast, automated data analysis, applying settings optimized throughout the development process of the biopharmaceutical.
These advanced automation capabilities provide considerable time savings in routine tests and enable streamlined data analysis in laboratories working in GxP environments.
Discover how Genedata Expressionist delivers increased sensitivity and accuracy with fewer false-positive identifications in HCP analysis.
Flexible Strategies. Increased Confidence.
The unique and flexible Genedata Expressionist data processing approach enables you to adapt and evolve MS-based host cell protein (HCP) detection workflows to meet your scientific needs.
For example, m/z and retention time coordinates of known impurities can be stored in a corporate knowledge base and used to identify HCPs in subsequent analyses.
Learn how Anders Giessing and his team at Novozymes use Genedata Expressionist for fully automated, truly high-throughput HCP analysis of a wide range of samples.
Efficient Processing. Increased Sensitivity.
To detect HCPs, Genedata Expressionist uses highly efficient algorithms for mass calibration, noise removal, and retention-time alignment and consolidates evidence of contaminating peaks across samples.
By applying consistency checks to distinguish real signals from noise and building isotope clusters based on known isotopic patterns, the software detects HCPs with high sensitivity (down to low-ppm levels) and high confidence.
Customer Stories
Achieving Fully Automated HT HCP Analysis
"Performing preprocessing using Expressionist delivers a tenfold acceleration in file loading times. High-throughput HCP analysis simply doesn’t work unless you have an efficient automated data processing and annotation workflow."
Characterizing Polysorbates Using Mass Spec
"The Expressionist software was key in visualizing the complexity of the PS-80 samples… the workflow-based approach made it easy to process and quantify large number of samples."