Next-Generation Sequencing as a Multi-Attribute Method for Monitoring Critical Quality Attributes of Gene Therapy Products

ASGCT, Baltimore, MD, USA
May 6, 2024

Developing and producing ATMPs (Advanced Therapy Medicinal Products), including gene therapies (GT), requires regular monitoring of the Critical Quality Attributes (CQAs) to ensure their safety and efficacy. Regulatory agencies, such as the FDA or EMA, can request thorough information from the biopharmaceutical companies about the CQAs of the product during the IND application. For this reason, a simplified set of tests and the proper technology to measure simultaneously various CQAs would be highly beneficial.

Genedata Selector^®, an enterprise software platform, automates next-generation sequencing (NGS) workflows and data analysis, enabling simultaneous measurement of several CQAs with higher sensitivity and at a faster rate. With this, biopharmaceutical companies can produce high-quality gene therapy products that meet both GMP requirements and clinical standards, reducing both the time-to-market and development costs.