Streamline Your Genetic Stability Testing With The NGS-Based Aptegra™ Platform

For decades, the genetic stability testing package for biopharmaceutical cell banks has remained relatively unchanged. This traditional method relies on a set of complex assays to meet ICH Q5B standards that often fall short in discovery power and sensitivity and demand lengthy timelines for completion.

The Aptegra™ CHO genetic stability assay revolutionizes this landscape with a single, streamlined test that delivers results in a third of the time. Leveraging the power of whole genome sequencing (WGS) and advanced bioinformatics, this assay delivers a faster, all-in-one solution for a comprehensive testing package. It covers gene of interest (GOI) sequence analysis, copy number determination, sequence analysis of flanking regions, integration site determination, and analysis of insertions or deletions.

Operating under a GMP-validated workflow, the Aptegra™ CHO genetic stability assay provides expert-reviewed results within 30 days, using less of your valuable cell bank resources.