MilliporeSigma Launches All-in-One Genetic Stability Assay for Biosafety Testing

MilliporeSigma, the U.S. and Canada life science business of Merck KGaA, Germany, says it 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, according to Benjamin Hein, head of life science services, the life science business of Merck.

“Driving innovation in biosafety testing is essential to bringing new therapies to patients faster,” said Hein. “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.”

Benjamin Hein
Benjamin Hein

Currently, FDA guidance requires 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, explains Hein.

Pain points

“Aptegra addresses these pain points by replacing five different assays and four different technologies with one assay utilizing the next-generation sequencing technology platform,” he continues. “This approach reduces testing time by 66 percent and reduces costs by 43 percent compared to traditional methods. The platform meets all regulatory requirements for genetic stability assurance, including copy number assessment.”

MilliporeSigma has made investments over the last five years to expand its biosafety testing capabilities for clients across the globe. The company’s global biosafety testing network includes sites in Shanghai, China; Singapore; Stirling and Glasgow, U.K.; and Rockville, MD.