Genedata Expressionist® Ready for Deployment in Regulated Environments


BALTIMORE, Maryland – Software platform automates workflows for characterization of biopharmaceuticals in drug discovery, development and manufacturing



Genedata, a leading provider of advanced software solutions for drug discovery and life science research, today announced major advances in applications for Genedata Expressionist® for Mass Spectrometry. The company's latest release of the popular software will be demonstrated at the 2015 Biotherapeutics Analytical Summit in Baltimore, MD.



Developed in collaboration with leading mass spectrometry (MS) labs, the enterprise software platform automates and standardizes the process of MS-based characterization of biotherapeutics from discovery and development to production and quality control. Supporting instruments from all major vendors, Genedata Expressionist for Mass Spectrometry accelerates data processing and analysis from raw data to final reports and ensures high-quality identification and quantification of critical quality attributes of biopharmaceuticals.



Ready for deployment in regulated environments



Designed to be compliant with GxP, release 9.0 of Genedata Expressionist for Mass Spectrometry features audit logging and electronic signatures. This infrastructure allows the implementation of standard operating procedures for workflow processes and methods and enables the formal approval of reports.



Facilitates collaboration and reproducibility



The data management infrastructure incorporated in the latest release of the software provides a chain of custody for each data point, ensuring reproducibility of reports and results, while the new project management infrastructure facilitates the sharing of methods, workflow processes and data across project teams and across the entire organization.



"With release 9.0, our market-leading software can now for the first time be used for the characterization of biotherapeutics in regulated environments, including late-stage development, production and quality control," commented Dr. Othmar Pfannes, CEO of Genedata. "This release represents a major step forward; it covers business processes end-to-end, facilitating collaboration right across the enterprise, while continuing to offer immense savings in time and cost through lightning-fast processing and analysis of data."



• Genedata Expressionist for Mass Spectrometry will be demonstrated at Genedata's display at Booth #6 in the Summit Exhibition.



• Joe Shambaugh, Ph.D., will present a talk entitled End-To-End Software Solution for Mass Spectrometry Based Biopharmaceutical Characterization in Track One (Analytical Methodology and PTMs), at 10:05 a.m. on Monday, March 9.



• A poster, Mass Spectrometry Software for the Modern Biopharma Enterprise by Joe Shambaugh, Alessio Ceroni, Arnd Brandenburg, Claudio Schmid and Peter Haberl, will be available for viewing throughout the conference.



About Genedata

Genedata transforms data into intelligence with a portfolio of advanced software solutions, which make research data accessible and understandable and research processes more efficient. These solutions are used worldwide by leading pharmaceutical, industrial, and agricultural biotechnology companies as well as academic research organizations. Genedata innovations enable scientific discovery that fights disease and improves health and quality of life worldwide. Founded in 1997, Genedata is headquartered in Switzerland, and has offices in Germany, Japan, and the US. http://www.genedata.com



Contact

Miles Fisher-Pollard

Genedata

Public Relations

Phone: +41-61-511-85-61

miles.fisher-pollard@genedata.com



Genedata AG

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