NGS-Driven Critical Quality Attribute Assessment of Biologically Synthetized mRNA Therapeutic Products
Bioprocessing Summit 2023, Boston, MA, USA
August 14, 2023
Maintaining in-process critical quality attributes (CQAs) is necessary to ensure the timely delivery of safe and effective biologically-derived mRNA-based therapies. Currently used approaches for monitoring CQAs have limitations, such as complexity and long duration, that are solvable with next-generation sequencing (NGS).
Genedata Selector® is an end-to-end enterprise software solution streamlining NGS-based assays for Advanced Therapy Medicinal Product (ATMP) development and manufacturing. Our secure platform supports NGS-based mRNA development assays providing data traceability for all analyses and report generation for internal and external audits. The provided clear go/no-go thresholds of the platform support faster and better-informed decisions regarding product integrity, potency, and biosafety. The software automates and standardizes NGS-based assays bringing life-changing treatments to production faster.