Merck unveils all-in-one genetic stability assay to accelerate biosafety testing

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. 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 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.

Merck has made significant 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, UK; and Rockville, MD, USA.

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 risk of late-stage failures. Additionally, Merck offers a first of its kind Bio4C Software Suite, which combines data analytics and visualization, automation, and control software for GMP manufacturing.

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