In-House Next Generation Sequencing Based Critical Quality Attributes Assessment of Gene Therapy Products

GTAD Europe, London, UK
May 14, 2024

The development and production of gene therapies (GT) necessitate consistent monitoring of Critical Quality Attributes (CQAs) to guarantee their safety and effectiveness. Regulatory authorities, such as the FDA or EMA, may require comprehensive details from biopharmaceutical companies regarding the CQAs of their products during the Investigational New Drug (IND) application process. Consequently, a streamlined set of tests and appropriate technology for measuring various CQAs at once is advantageous.

Genedata Selector^®, an enterprise software solution, streamlines next-generation sequencing (NGS) workflows and data analysis, enabling the simultaneous measurement of multiple CQAs with greater sensitivity and speed. This enables biopharmaceutical companies to produce high-quality gene therapy products that comply with Good Manufacturing Practice (GMP) standards and clinical requirements, thereby shortening the time to market and reducing development expenses.