Merck

Find Simplicity in Stability

Streamline Your CHO Genetic Stability Testing with the Aptegra™ Platform

Aptegra™ CHO Genetic Stability Assay

Streamline Your Genetic Stability Testing with the NGS-based Aptegra™ Platform

The genetic stability testing package for biopharmaceutical cell banks has remained relatively unchanged for decades. This traditional approach to genetic stability testing relies on a complex set of assays to meet ICH Q5B requirements, many of which have limitations in discovery power and sensitivity and require long timelines for completion. 

The proprietary Aptegra™ platform delivers the first streamlined, single-test replacement of traditional methods with the Aptegra™ CHO genetic stability assay delivering results in a third of the time. This assay taps into the combined power of whole genome sequencing (WGS) and expert bioinformatics to deliver a faster, all-in-one solution for a comprehensive testing package, including: 

  • Gene of interest (GOI) sequence analysis
  • Copy number determination
  • Sequence analysis of flanking regions
  • Integration site determination
  • Analysis of insertions or deletions

The Aptegra™ CHO genetic stability assay operates under a GMP-validated workflow to return expert-reviewed results in 30 days using less of your precious cell bank. 

Stability testing should be simple, by tapping into the whole genome, it can be. The Aptegra™ CHO genetic stability assay:

  • Replaces Southern, Sanger sequencing, PCR, and FISH with a single technology
  • Utilizes expert bioinformatics to address all genetic stability regulatory requirements
  • Eliminates primer bias, design time, and assay optimization
  • Eradicates any guesswork in data interpretation
  • Reduces upfront client time with off-the-shelf ordering
  • Consistently delivers fast, reliable results

Aptegra™ CHO Genetic Stability assay vs. the traditional package of five assays

* Actively growing cells required for FISH analysis​
** Recommended for ddPCR and Southern blot assays


Simplify your genetic stability testing with the Aptegra™ platform.

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