New software release simplifies GMP validation of in-house NGS-based assays, enabling faster and more accurate assessment of critical quality attributes in cell and gene therapy
Genedata, a Danaher company, and the leading provider of enterprise software solutions for biopharmaceutical R&D, today announced a new release of Genedata Selector®. This end-to-end solution automates next-generation sequencing (NGS) data processing and analysis, accelerating decision-making for more efficient quality control of advanced therapies. The new version of Genedata Selector further enhances data integrity by seamlessly connecting systems, facilitating efficient transfer of data, projects, and processes between collaborating stakeholders.
Characterizing cell and gene therapies using NGS requires transforming large volumes of complex sequencing data into actionable insights. Companies must also ensure that data analyses are conducted accurately in a secure and compliant environment, with complete documentation demonstrating validated IT systems to support regulatory submissions. Developed in close collaboration with industry-leading partners, the GxP-compliant features of Genedata Selector simplify the validation process for biopharmaceutical companies, facilitating a seamless path to regulatory approval.
The new features of the software further enhance GMP validation by enabling structured handover of data and processes between research, quality assurance, and manufacturing teams. Genedata Selector provides full traceability of data processing activities through built-in version control, allowing biopharmaceutical companies to automatically track every action — who performed it, when, and on which dataset.
To support expanded Multi-Attribute Method (MAM) applications, this software release also includes a broad catalog of NGS workflow activities, enabling companies to unlock the full potential of NGS assays in house. The new version of Genedata Selector connects with data management systems such as LIMS, ELNs, as well as laboratory hardware, compute environments, and secure file storage systems to deliver the highest levels of automation. The new enhancements improve sample tracking, data loading, and sequence data integration. Together, the new capabilities of Genedata Selector help biopharma teams work more efficiently, minimize errors, and deliver consistent results across the development and manufacturing lifecycle of cell and gene therapies.
“As new regulations continue to emerge, it is increasingly important for biopharma companies to stay informed and adapt to the latest guidelines,” said Othmar Pfannes, Ph.D., President of Genedata. “In complex organizations and regulated environments, maintaining the chain of custody and ensuring data reaches the right stakeholders at the right time can be challenging. We have therefore enhanced Genedata Selector to improve collaboration and automation while supporting compliance across the entire data lifecycle to accelerate the manufacturing of advanced biotherapeutics.”
About GenedataGenedata, a Danaher company, transforms data into intelligence with innovative software solutions that incorporate extensive biopharma R&D domain knowledge. Multinational biopharmaceutical organizations and cutting-edge biotechs around the globe rely on Genedata to digitalize and automate data-rich and complex R&D processes. From early discovery all the way to the clinic, Genedata solutions help maximize the ROI in R&D expenditure. Founded in 1997, Genedata is headquartered in Basel, Switzerland with additional offices in Boston, London, Munich, San Francisco, Singapore, and Tokyo.www.genedata.comLinkedIn| YouTube
About DanaherDanaher is a leading global life sciences and diagnostics innovator, committed to accelerating the power of science and technology to improve human health. Our businesses partner closely with customers to solve many of the most important health challenges impacting patients around the world. Danaher's advanced science and technology – and proven ability to innovate – help enable faster, more accurate diagnoses and help reduce the time and cost needed to sustainably discover, develop and deliver life-changing therapies. Focused on scientific excellence, innovation and continuous improvement, our approximately 63,000 associates worldwide help ensure that Danaher is improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow. Explore more at www.danaher.com.
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