Unlocking Opportunities with NGS for Critical Quality Attribute Measurement of Gene Therapy Products

GTAD 2023, Boston, US
November 27, 2023

An increasing number of gene therapies (GT) are being developed. For these treatments, speed and safety are critical for success. with in-process testing required to ensure that these therapeutics maintain their  critical quality attributes (CQAs). For gene therapies, CQAs include identity, integrity, and safety.

Next-Generation Sequencing (NGS) is a multi-attribute method for GT products that can eliminate the need for several different assays to determine CQAs and can streamline multiple assays in a single workflow. However, the wealth of data produced by NGS need to be analyzed efficiently and by sophisticated algorithms to make data-driven decisions. Genedata Selector^® is the end-to-end enterprise software solution and single point of access that streamlines CQA measurement of gene therapy products with NGS-based assays. Automation and standardization of complex NGS-based assays can result in life-changing treatments reaching production faster.