New Release of Genedata Expressionist For Innovative Characterization and Automated Quality Monitoring of Next-Generation Biotherapeutics

Latest enterprise software release expands functionalities for comprehensive characterization and quality monitoring of biopharmaceuticals

October 18, 2022
Basel, Switzerland

Genedata, the leading provider of enterprise software solutions for biopharmaceutical R&D, today announced the release of Genedata Expressionist^® 16.5, the latest version of its platform for streamlining and automating mass spectrometry data workflows, from early discovery to late-stage development. Genedata Expressionist 16.5 takes characterization and quality monitoring of biotherapeutics and oligonucleotides to the next level by enabling leading biopharma companies to fully leverage the potential of mass spectrometry data in their R&D workflows, irrespective of the instrument or technology applied.

Genedata Expressionist 16.5 introduces top-down protein sequencing using tandem mass spectrometry (MS/MS) to address the growing need to rapidly analyze expected drug proteoforms—for example, in biosimilar assessment—on an industrial scale. This release further enhances the established characterization workflows built into Genedata Expressionist for the identification of multiple clipping events in biotherapeutics. Smart filters reduce the number of false-positive clipping results that are typically obtained in such analyses, significantly reducing the time required to review large data sets. These new capabilities enable scientists working in biopharma to not only meet current and emerging analytical challenges, but also allow them to keep pace with ever-increasing molecular complexity and process scale.

As the industry leader in end-to-end automation of MS data analysis, Genedata Expressionist now offers automated product quality monitoring of emerging modalities—such as therapeutic oligonucleotides. Expert users can easily define critical quality attributes (CQAs) of any molecular structure and monitor them using routine automated processes. The generated results can be verified using a new interactive CQA review process, enabling users to leverage and integrate their knowledge into the overall automated workflow. With the introduction of these novel product quality monitoring capabilities, this release further cements the position of Genedata Expressionist as the platform of choice for the automation of MS data analysis across all stages of drug discovery, development, and manufacturing.

“The inherent complexity of innovative biotherapeutics necessitates comprehensive characterization and robust product quality assessment. The new characterization functionalities in Genedata Expressionist 16.5 deliver deeper insights, enabling our industry partners to ensure the safety and efficacy of their drugs, while novel automation capabilities for CQA monitoring accelerate and streamline processes throughout R&D,” stated Othmar Pfannes, Ph.D., CEO of Genedata. “We will continue to work closely with leading biopharma companies to deliver the automated data processing solutions required to develop next-generation therapies.”