MilliporeSigma introduces the world’s first all-in-one genetic stability assay
MilliporeSigma, the life science business of Merck KGaA (Darmstadt, Germany) has just launched the world’s first all-in-one genetic stability assay.
The assay goes by the name of Aptegra™ CHO (Chinese hamster ovary) and promises to expedite biosafety testing processes for clients, as well as fast-track the transition to commercial production.
“Driving innovation in biosafety testing is essential to bringing new therapies to patients faster,” emphasized Benjamin Hein, Head of Life Science Services at MilliporeSigma. “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.”
To meet genetic stability requirements for CHO cells, the favored host cells for producing therapeutic proteins and a staple in biopharmaceutical manufacturing, FDA regulations currently mandate biotech companies to undertake multiple assays. This is not only time-consuming and expensive, but also often requires further data interpretation.
The Aptegra platform eliminates these challenges by consolidating five assays and four technologies into a single, comprehensive assay leveraging next-generation sequencing and bioinformatics technology.
Impressively, the platform lowers testing duration by 66% and costs by 43% compared to conventional methods. Furthermore, Aptegra meets all the stringent regulatory standards for genetic stability assurance, including copy number assessment: an important stability measure of productivity in CHO.
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MilliporeSigma’s commitment to advancing biosafety testing capabilities is emphasized by significant investments made over the past 5 years. With a global biosafety testing network spanning the US, China, Singapore and the UK, the company is poised to cater to clients worldwide.
The introduction of the Aptegra platform marks another milestone in MilliporeSigma’s digital innovation journey. Complementing its existing portfolio of transformative digital technologies, including the AI-powered AIDDISON® platform and Bio4C® Software Suite, the Aptegra platform reaffirms MilliporeSigma’s dedication to driving technological advancements in the life sciences sector.
