Unlimited and GxP-Ready NGS-Analyses
Genedata Selector
Ensuring the quality of Advanced Therapy Medicinal Products (ATMPs), such as gene or cell therapies, is crucial to ensure safety and efficacy. Next-generation sequencing (NGS) used as a multi-attribute method (MAM) can address all product characterization and quality control needs in just a single assay. Although NGS accelerates R&D and commercial manufacturing, it also creates a vast amount of data, which poses many IT challenges related to data integration, management, and analysis.
Genedata Selector® is an end-to-end software solution that handles all data resulting from NGS-based assays. As a sequencing technology-agnostic platform, it simplifies sample and data management and enables automated analysis, intuitive visualization, and the integration of NGS data with other data types (Fig. 1 A and B). The software unlocks the power of NGS as a MAM approach (Fig. 2). Genedata Selector is an integrated, in-house single source of truth that enables GMP validation by providing documentation for internal assessment or submission to regulatory authorities.