Genedata Collaborates with Astellas to Facilitate Regenerative Cell Therapy Product Development

Global pharmaceutical company implements Genedata Selector to automate the analysis of NGS-driven assays for adventitious agent detection during cell therapy development

September 18, 2023
Basel, Switzerland

Genedata, the leading provider of enterprise software solutions for biopharmaceutical R&D, today announced that the Astellas Institute for Regenerative Medicine (AIRM), a subsidiary of Astellas Pharma Inc. and a global pharmaceutical company has licensed Genedata Selector^® to help confirm the biosafety of cell therapies using NGS-based assays within a validated environment. 

AIRM aims to shorten the time it takes to reach first-in-human studies and deliver safe and effective cell therapies to the market. To help with this, AIRM adopted Genedata Selector, a platform that leverages the sensitivity and speed of NGS to detect adventitious agents and provide information for future “off-the-shelf” cell-based therapies through automated insight generation. The Genedata Selector platform provides access to expertise in NGS-based assay definition, data processing, and analysis. The software provides technical capabilities for standardizing and automating NGS-based analyses, simplifying results interpretation, and supporting computerized system validation (CSV) to help streamline AIRM's development efforts.

Genedata Selector is an end-to-end enterprise platform that consolidates scientific and validation consulting services. It assists biopharmaceutical companies in development of innovative therapies, in confirming critical quality attributes, and making informed decisions throughout the drug development process. The software features unique “Playbooks” that offer user-friendly interfaces for automating NGS-based analyses, including adventitious agent detection. Genedata Selector is fully compliant with FAIR data principles, as all results are associated with sample information that can be easily accessed, monitored, and tracked. The platform promotes data democratization and collaboration, helping researchers generate new insights and provide clear go/no-go signals for agile decision-making.

AIRM plans to leverage the Genedata Selector to help automate workflows, reduce bottlenecks, and speed up progress toward cell therapies.

“We are excited about our collaboration with Astellas in the context of automating the analysis of NGS-based assays to ensure the biosafety of cell therapy products,” said Othmar Pfannes, Ph.D., CEO of Genedata. “We have recognized the need to accelerate complex processes in biopharma R&D and are committed to investing into Genedata Selector as a platform for the automation of NGS-based assays for a variety of key workflows, such as the identification of viral contamination in bioreactors in GxP as well as non-GxP environments. We look forward to providing innovative leaders like Astellas a platform to bring therapies to market efficiently.”