Genedata Selector 8.0リリース：高品質な細胞・遺伝子治療の開発を加速

Latest release of innovative enterprise solution equips biopharma R&D with automated workflows to confirm the identity, efficacy, and safety of biotherapeutics

March 3, 2022
Basel, Switzerland

Genedata, the leading provider of enterprise software solutions for biopharmaceutical R&D, today announced the release of Genedata Selector 8, the latest version of its innovative platform for NGS-based assay analytics. The software enables biopharmaceutical R&D teams to digitalize and automate complex experimental workflows and specifically leverage Next-Generation Sequencing (NGS) data for deep bioprocess and biotherapeutic characterization as well as adventitious agent detection.

In particular, the development of effective cell & gene therapies (CGTs), but also other biotherapeutics, requires fully integrated software solutions that speed up complex data analytical processes, while generating results of the highest quality. Furthermore, biological materials (e.g., raw material including cells, gene delivery systems like AAV, vectors, and growth media) require continuous quality assessment at the molecular level. Typical quality assessment challenges include in-depth host cell characterization, clone validation, ‘in-process” confirmation of material identity, early detection of adventitious agents within the bioreactor, as well as sterility assessment of the final biotherapeutic product. NGS has become a key technology in biopharma R&D to address such challenges and Genedata Selector is emerging as the platform of choice to support all NGS-driven workflows in biopharma R&D within GxP compliant environments.

Genedata Selector^® is a future-proof platform that automates analytical workflows of NGS-based assays with out-of-the-box playbooks, guided interfaces for running analyses for a variety of applications. The solution is applied to establish critical quality attributes of CGTs and other biotherapeutics throughout research, development, and manufacturing. The platform reduces workflow complexity by offering: 
  
•    Easy and flexible integration of new technologies (CRISPR, TLA, ScRNA-Seq) and automated analysis and visualization of NGS data. 
•    Complete tracking of all sample information (including genomic and phenotypic information) maintaining full data integrity. 

Genedata Selector 8 has been developed in close collaboration with innovative leaders in the biopharma industry to address the rapidly emerging needs of an exciting field in bioprocess development. Preliminary ROI analyses show considerably reduced project times e.g., for clone selection or adventitious agent detection, and significantly improved team productivity. By having all data and results at the fingertips, decision-making, reporting, and regulatory submissions have become simpler, faster, and more transparent.

“We have recognized the need to speed up highly complex NGS-driven experimental workflows in bioprocess development. In close collaboration with some of the most innovative leaders in the industry, we have developed Genedata Selector to enable biopharma organizations to bring innovative biotherapeutics like CGTs as quickly as possible to patients,” said Othmar Pfannes Ph.D., CEO of Genedata. “We are committed to contributing to this exciting field and collaborating with other innovators to further improve analytical approaches for accelerated safe and efficacious therapy development.”