SINGAPORE, April 17: Merck has launched the first all-in-one, validated genetic stability assay to significantly accelerate biosafety testing for clients and thus, their move into commercial production.
Genetic stability testing is a critical component of quality assurance for biological products derived from cell cultures.
Named The Aptegra™️ CHO genetic stability assay, it leverages whole genome sequencing and bioinformatics.
Benjamin Hein, Head of Life Science Services, Life Science business of Merck said the assay is essential to bringing new therapies to patients faster.
“Genetic stability testing has remained relatively unchanged for many years.
“The Aptegra™️ platform transforms biosafety testing with a digital solution using next-generation sequencing,” said Hein in a statement.
Currently, U.S. Food and Drug Administration (FDA) guidelines require biotech companies to use multiple assays to address genetic stability requirements.
This traditional package of assays is costly, time-consuming, and often results in data that need additional interpretation and support
The Aptegra™️ addresses these pain points by replacing five different assays and four different technologies with one assay utilizing the next-generation sequencing technology platform.
It reduces testing time by 66 percent and lowers costs by 43 percent compared to traditional methods. – TVS
