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Merck debuts new genetic stability process to accelerate biopharmaceutical testing
A scientist prepares samples in the next-generation sequencing laboratory at Merck's/MilliporeSigma's Rockville site. (Merck photo)
Merck debuts new genetic stability process to accelerate biopharmaceutical testing
Listen to this articleMerck, a leading global technology company with a U.S. laboratory in Rockville, launched the Aptegra CHO Genetic Stability Assay, which leverages whole-genome sequencing and bioinformatics to significantly accelerate customers’ biopharmaceutical safety testing, thereby helping to accelerate customers’ entry into commercial production.
Currently, U.S. Food and Drug Administration (FDA) guidance requires biotech companies to use multiple assays to meet genetic stability requirements. This traditional testing method is costly, time-consuming, and often requires additional interpretation and data. The Aptegra ™ platform addresses these pain points by replacing five different assays and four different technologies with one assay using a next-generation sequencing technology platform. Compared with traditional methods, this method can shorten the detection time by 66% and reduce the cost by 43%. The platform meets all regulatory requirements for genetic stability assurance, including copy number assessment.
Over the past five years, Merck has made significant investments in expanding its biopharmaceutical testing capabilities. Merck’s global network of biopharmaceutical testing centers is located in Rockville, Shanghai, Singapore, China and Stirling and Glasgow in the United Kingdom.
