Merck launches genetic stability assay to accelerate biosafety testing
The Aptegra CHO genetic stability assay leverages whole genome sequencing and bioinformatics to significantly accelerate biosafety testing
Merck has launched the first all-in-one, validated genetic stability assay of its kind. The Aptegra CHO genetic stability assay leverages whole genome sequencing and bioinformatics to significantly accelerate biosafety testing for clients and therefore, their move into commercial production.
“Driving innovation in biosafety testing is essential to bringing new therapies to patients faster,” said Benjamin Hein, Head of Life Science Services, Life Science business of Merck. “CHO genetic stability testing has remained relatively unchanged for many years. The Aptegra platform transforms biosafety testing with a digital solution using next-generation sequencing.”
Currently, FDA guidance requires biotech companies to use multiple assays to address genetic stability requirements. This traditional package of assays is costly and time-consuming and often results in data that need additional interpretation and support. The Aptegra platform addresses these pain points by replacing five different assays and four different technologies with one assay utilizing the next-generation sequencing technology platform. This approach reduces testing time by 66 per cent and reduces costs by 43 per cent compared to traditional methods. The platform meets all regulatory requirements for genetic stability assurance, including copy number assessment.
The Aptegra digital platform adds to a transformative portfolio of digital technologies developed by Merck. In December, Merck launched AIDDISON, an AI-powered platform that integrates generative design with predictive synthesis planning, allowing rapid identification of promising candidates and reducing the risk of late-stage failures. Additionally, Merck offers a first-of-its-kind Bio4C Software Suite, which combines data analytics and visualisation, automation, and control software for GMP manufacturing.
