Genedata Expressionist 13.0 Streamlines In-depth Characterization and Automates Quality Monitoring of Biopharmaceuticals
Latest release of enterprise software solution that enhances efficiency of biopharmaceutical development with special focus on supporting Multi-Attribute Methods (MAM) showcased at 2019 ASMS
June 4, 2019
Atlanta, GA, USA
Genedata, a leading provider of enterprise software solutions for biopharmaceutical R&D, today announced the release of Genedata Expressionist® 13.0 at the 2019 ASMS Conference. The release streamlines mass spectrometry (MS)-based characterization of biotherapeutics and automates knowledge-assisted analysis, with a special focus on implementing Multi-Attribute Methods (MAM) to monitor the quality of biopharmaceuticals throughout biopharmaceutical development and manufacturing.
Developed in close collaboration with partners across the biopharmaceutical industry, Genedata Expressionist provides unique workflow solutions addressing specific customer needs through out-of-the-box software functionalities. These solutions can be configured to automate complex MS data processing steps, enabling customers to scale up their experimental throughput.
The new release includes the following highlights:
- A new, flexible, user-definable approach to peptide mapping and sequence variant analysis (SVA) that reduces false-positive annotations while maximizing sensitivity, enabling best-in-class molecule characterization—important for next-generation Multi-Attribute Method (MAM) implementations.
- Advanced iterative review and commenting capabilities together with insightful visualizers that streamline the curation of peptide mapping results. Further, curated results can now be easily incorporated as custom libraries and leveraged in downstream MAM monitoring processes, aiding automated quantification of Critical Quality Attributes (CQAs).
- Increased configurability allowing customized reporting and preventing time-consuming report reformatting. A unique integrated report approval process with signing functionalities makes Genedata Expressionist the solution-of-choice for MAM deployment in regulated environments.
Beyond streamlining workflows for characterization of biopharmaceuticals, Genedata Expressionist is increasingly being adopted to automate Host-Cell Protein (HCP) analysis due to its advanced built-in capabilities for proteomics analysis. As an instrument- and vendor-agnostic software platform, Genedata Expressionist continues to support the latest high-end MS instruments and thereby create new analytical solutions that address unmet needs. For this release, Genedata worked closely with Bruker to support their novel timsTOF Pro instrument; providing customers with a high-performance HCP and proteomics analytical system that offers unparalleled speed, scalability, and sensitivity.
By streamlining and automating complex MS data processing, analysis, and reporting workflows within and across laboratories, Genedata Expressionist empowers scientists to make informed decisions based on high-quality results.
"The latest release of Genedata Expressionist—an important component of our Genedata Biopharma Platform—reinforces our continued commitment to support the rapidly evolving needs of the biopharmaceutical industry, such as support of MAM. Genedata Expressionist enables our customers to efficiently scale up their internal data processing workflows, while at the same time improving result quality," commented Dr. Othmar Pfannes, CEO of Genedata. "Furthermore, we remain committed to partnering with leading technology providers such as Bruker to offer our joint customers new solutions to not only accelerate discovery, development, and commercialization of novel biopharmaceuticals, but ultimately also to reduce costs by streamlining and automating complex analytical processes."