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Genedata AG. (2/6/18). "Press Release: Genedata Announces New Solution for NGS-Based Biosafety Assessment". Basel.

Organisation Organisation Genedata AG
  Group Genedata (Group)
Product Product  quality control diagnostics
Person Person Pfannes, Othmar (Genedata 200406 CEO)

Genedata Selector for Biosafety streamlines the detection of adventitious agents using next-generation sequencing

Genedata, a leading provider of advanced software solutions for R&D, today announced the availability of Genedata Selector for Biosafety, an innovative software platform enabling adventitious agent detection based on next-generation sequencing (NGS) data. The new offering allows for efficient management and analysis of all NGS data relevant for biosafety assessment, plus automatic report generation compliant with GMP workflows. From QC assay development to bulk lot release testing, Genedata Selector can manage and analyze NGS data from any sample including raw materials, cell banks, or bulk manufacturing lots.

NGS is an effective method for detecting adventitious agents due to its speed and ability to identify any nucleic acid contaminant that may be present. NGS also provides an additional level of biosafety assurance that can support traditional testing methods such as in vitro and PCR-based assays. Genedata Selector for Biosafety is the first-in-class commercially available software solution that supports this paradigm shift. Designed with a user-friendly interface, Genedata Selector supports the entire biosafety workflow from sample management, to automated NGS data analysis, and flexible reporting.

> Sample management is important for maintaining accurate records of the data generated with NGS assays. Sample submissions are created in the software using step-wise prompts and controlled vocabulary to eliminate duplication or data entry errors.

> NGS data analysis workflows are automated and standardized providing faster turn-around times and reproducible results. Whether performing DNA or RNAseq, these workflows can be “locked-down” for use in GMP compliant environments.

> Reporting functionality provides a flexible solution for creating clear and concise documents that can be used for both internal and external purposes. Reports can be shared with other users of the software using built in collaboration tools.

> Regulatory compliance is supported with user access logs and system transaction records. Only authenticated users have access to the system. System transactions are recorded and time stamped to allow for 21 CFR part 11 compliant operation.

“With Genedata Selector for Biosafety, we have created a new and innovative solution for a critical aspect of the biopharma business,” says Othmar Pfannes, CEO of Genedata. “Our collaborative approach of working with leaders in the biopharma industry shows our commitment to continuously provide innovative solutions for current challenges.”

About Genedata

Genedata transforms data into intelligence with innovative software solutions and domain-specific consulting services that automate complex, large-scale experimental processes and enable organizations to maximize the ROI from their R&D. Founded in 1997, Genedata is headquartered in Switzerland and has offices in Germany, the UK, Japan, and the US.


The statements in this press release that relate to future plans, events or performance are forward-looking statements that involve risks and uncertainties, including risks associated with uncertainties related to contract cancellations, developing risks, competitive factors, uncertainties pertaining to customer orders, demand for products and services, development of markets for the Company's products and services. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to release publicly the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

All product and service names mentioned are the trademarks of their respective companies.

Record changed: 2018-02-11


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