Optimizing CGT Product Development & Manufacturing

Cell and gene therapies (CGT) are novel biotherapeutics that aim to treat, prevent and potentially cure disease by modifying either cells or genes. Ensuring various critical quality attributes (CQAs) such as biosafety, identity, and potency of such therapies is critical to their ability to achieve their intended purpose. Next-generation sequencing (NGS) is a powerful tool for efficiently assessing CQAs. NGS-based assays provide an unbiased, sensitive, and faster approach than traditional methods, requiring significantly less biological input material.

Genedata Selector^® is an end-to-end software solution for all NGS-based assays. The platform simplifies sample and data management while enabling automated analysis, intuitive visualization, and reporting. Genedata Selector is a single source of truth that easily integrates into GMP environments to generate reports for internal documentation and regulatory submissions, transforming data into actionable results.