Genedata Selector Ensures GMP Compliance for Safe and Efficient Gene Therapy Development

GTAD 2024, Boston, US
October 30, 2024

Biopharmaceutical companies are increasingly adopting Next Generation Sequencing (NGS)-based assays to assess Critical Quality Attributes (CQA) and ensure the safety of biotherapeutics, including gene therapies.

Genedata Selector^® is an innovative enterprise software platform designed to address the computational challenges of processing, analyzing, and managing NGS data while meeting Good Manufacturing Practices (GMP) requirements. The platform harmonizes and accelerates complex workflows, creating a single source of truth for all NGS data. It includes 21 CFR Part 11-compliant features and a validation-ready documentation package, supporting efficient Computerized System Validation (CSV) projects. NGS has also emerged as a sensitive method for viral safety testing, adhering to ICH Q5A(R2) guidelines. Genedata Selector simplifies and streamlines NGS biosafety workflows in a GMP environment, ensuring reliable results, faster turnaround times, and improved ROI. This contributes to safer, more efficient, and ethical biotherapeutic development.