ポスター：次世代シーケンス（NGS）による遺伝子治療製品の重要品質特性（CQA）評価

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.