Genedata Expressionist 18.0 Sets New Benchmarks in Biotherapeutic Characterization and GxP-compliant MS Data Review

Latest release expedites review of large data sets and offers new protein characterization functionalities for disulfide bond mapping and top-down mass spectrometry

May 30, 2024
Basel, Switzerland

Genedata, the leading provider of enterprise software solutions for biopharmaceutical R&D, today announced the release of Genedata Expressionist^® 18.0, its platform for streamlining and automating characterization and quality monitoring of biotherapeutics using mass spectrometry (MS). New algorithms for in-depth protein characterization streamline the development of novel biotherapeutics and advanced review functionalities facilitate implementation of MS-based analytics in GxP environments. Genedata Expressionist 18.0 will be showcased at the upcoming 72^nd Annual Meeting of the American Society for Mass Spectrometry on June 2–6, 2024 in Anaheim, California.

Novel and increasingly complex biotherapeutic modalities present new characterization challenges; not least in determining the arrangement of their disulfide bonds, which play a key role in protein folding, function, and stability. Genedata Expressionist 18.0 introduces novel algorithms that dramatically accelerate mapping of disulfide bonds and other crosslinks within proteins, reduce the number of false-positive annotations, and automatically flag mispaired “scrambled” linkages. This analytical breakthrough addresses a complex challenge and delivers a robust solution that boosts productivity in biotherapeutic characterization.

This release also introduces new capabilities to streamline and optimize cutting-edge top-down MS approaches. By combining and consolidating results from multiple fragment mapping experiments, Genedata Expressionist 18.0 provides a broader coverage over the complete protein. Extending the out-of-the box capabilities of Genedata Expressionist to support novel MS-based methods demonstrates Genedata’s commitment to provide its industry partners with the most innovative and effective analytical technologies available today.

In addition, the new release facilitates review of MS results, reducing workload on experts and enabling multi-attribute method (MAM) approaches for biotherapeutic quality monitoring. After Genedata Expressionist workflows have provided fully automated MS data processing and analysis, experts can manually verify, correct, and approve each individual result down to the peak integration level. All manual interactions, comments, and changes are added to a comprehensive audit trail that delivers full transparency and traceability and facilitates the implementation and operation of compliance in stringently regulated GxP environments.

“This latest Genedata Expressionist release sets a new benchmark for MS-based in-depth characterization of novel therapeutics, meeting the growing industry need for detailed functional information as drug portfolios evolve and molecular complexity increases,” stated Othmar Pfannes, Ph.D., CEO of Genedata. “Moreover, by facilitating the implementation of MAM in regulated environments, Genedata Expressionist accelerates biopharma R&D; enhancing the efficiency, accuracy, and the comprehensiveness of quality monitoring of biopharmaceuticals.”