Genedata Selector 10 Supports NGS-Based Assays in GxP Environments

Major software release enables biopharma organizations to meet the latest ICH Q5A(R2) guideline

June 18, 2024
Basel, Switzerland

Genedata, the leading provider of enterprise software solutions for biopharmaceutical R&D, today announced a new release of Genedata Selector^®, an end-to-end platform that automates quality control processes and expedites the delivery of safe and efficacious biotherapeutics to patients.

Genedata Selector provides a single source of truth for monitoring critical quality attributes (CQAs) during the development and manufacturing of biotherapeutics, including cell and gene therapies, and enables data-driven decision-making. The platform’s modular architecture connects all stages along the R&D and manufacturing process and empowers analytical teams to integrate, analyze, and share NGS results accurately and efficiently. This streamlines automation and process standardization across the organization and ensures adherence to FAIR (Findable, Accessible, Interoperable, and Reusable) data principles and GxP compliance.

Genedata Selector revolutionizes workflow automation using Playbooks which can be integrated with Nextflow pipelines and functionality. The latest update introduces a state-of-the-art workflow editor that allows users to optimize the development, testing, and tuning of data processing workflows used in assay development. An intuitive user interface fosters collaboration between scientists and quality experts, accelerating the deployment of assays in validated environments. A newly introduced automation engine provides novel ways to achieve enterprise-level scalability for deployment, including in cloud environments.

Ready to use out-of-the-box, Genedata Selector 10 is equipped with all necessary GxP functionalities and is validation-ready for deployment in regulated environments. The software complies with the FDA's 21 CFR Part 11 regulation. Wizard-based Playbooks streamline across sample registration, NGS data processing, and analysis to reporting, simplifying submissions to regulatory authorities. The Genedata QA team has extensive experience in developing standardized and customized validation-ready solutions for NGS-based assays, tailored to the unique needs of diverse projects. Additionally, Genedata offers validation support services to assist in Computerized System Validation (CSV) projects.

“With the recently updated ICH Q5A(R2) guideline, biopharma companies can now use NGS for biosafety assessment instead of using costly and time-consuming in vitro and in vivo assays. Genedata Selector not only accelerates the analysis and interpretation of these NGS assays, but also meets regulatory standards,” said Othmar Pfannes, Ph.D., CEO of Genedata. “Genedata Selector 10 marks a significant milestone in our mission to enable the biopharma industry to harness the power of NGS in a validated environment and increase the ROI of their in-house investments. We remain committed to further investing in process automation and integration to assist our customers in transitioning their in-house NGS assays into a GxP environment and shorten the time-to-market of life-changing therapeutics.”

Editorial Note: To learn more about Genedata Selector 10 and view the software in action, please click here.