Genedata Selector for Biosafety リリース：
NGSによるバイオセーフティー試験に対応

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

February 6, 2018
Basel, Switzerland

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.”