Advancing Cell Therapies Using NGS as a Multi-Attribute Method

March 25, 2024

Cell therapies (CT) are novel biotherapeutics that aim to treat, prevent, and potentially cure disease by modifying either cells or genes. Ensuring the efficacy and safety of cell therapies is critical to achieving their intended purpose. Next-Generation Sequencing (NGS) is a powerful tool for assessing Critical Quality Attributes (CQAs) to confirm the biosafety, identity, and integrity of cell therapies. NGS-based assays provide an unbiased, more sensitive, and rapid approach than traditional methods while requiring significantly less biological input material.

Using allogeneic skin graft samples obtained from the Fraunhofer Institute for Interfacial Engineering Biosafety and Biotechnology IGB in Stuttgart, Germany, we demonstrate how Genedata Selector^® supports the assessment of CQAs of cell therapies by implementing NGS as a multi-attribute method (MAM).