Off-the-Shelf Analysis Solution for GMP-Compliant NGS Assays in Biologics Development
Genedata Selector
Next-generation sequencing (NGS) assays have revolutionized the analytical characterization and manufacturing of advanced biotherapeutics by providing an unbiased, more sensitive, and faster approach than traditional methods. Genedata Selector® is your all-encompassing, off-the-shelf analysis solution for all NGS-based assays to simplify sample management and data analysis. Powered by Playbooks, wizard-based guides, Genedata Selector unlocks a powerful multi-attribute method (MAM) for assessing multiple critical quality attributes (CQAs) such as biosafety, identity, potency, and integrity of biotherapeutics in a single assay. As a GMP-compliant platform, Genedata Selector automates NGS data analysis workflows to generate reports for internal evaluation and regulatory submissions.