Leveraging In-House Short- and Long-Read NGS Technologies for Optimal QC in Gene and Cell Therapy Manufacturing
April 28, 2025
Biopharmaceutical companies are increasingly adopting next-generation sequencing (NGS)-based assays in the manufacturing process of cell and gene therapies to assess Critical Quality Attributes (CQAs) such as product integrity and safety. Long-read sequencing has further advanced the field of NGS by complementing broadly used short-read technologies. Long-read NGS-based assays offers numerous benefits over short-read sequencing and can be used for CGTs development and manufacturing to:
- detect fusion or truncation events to ensure product safety and efficacy,
- fully sequence plasmids and vectors to verify the integrity and orientation of gene inserts,
- ensure the presence of promoted and correct, error-free adeno-associated viruses (AAVs) packaged into capsids.
Genedata Selector® platform supports NGS data analysis and management for biopharmaceutical companies. It enables the optimal use of both short- and long-read sequencing in manufacturing QC assays of CGTs for optimal results. GMP-compliant features automate and streamline all in-house NGS workflows in a GMP environment, significantly improving return on investment (ROI).
