MilliporeSigma has secured a major five-year pact with Genetix Biotherapeutics to become the sole provider of analytical and biosafety release testing for the company’s gene therapy portfolio, deepening a partnership that has spanned more than a decade.
The deal positions MilliporeSigma at the center of commercial manufacturing for three breakthrough gene therapies targeting sickle cell disease, β-thalassemia, and cerebral adrenoleukodystrophy — rare, life-threatening disorders for which Genetix has developed one-time treatments.
The agreement comes as demand for commercial-scale cell and gene therapies accelerates, placing growing pressure on drugmakers to secure reliable, high-quality testing partners capable of supporting complex global supply chains.
“As cell and gene therapies continue to move into commercial use as treatments for devastating diseases, this agreement underscores the critical role our high-quality BioReliance analytical and biosafety testing plays,” said Paolo Carli, Head of Advanced Solutions for the Life Science business of Merck KGaA, Darmstadt, Germany.
“With more than 75 years of specialized expertise in these areas, we are the innovation partner for customers at their most complex points in the development and commercialization of novel modalities.”
Under the agreement, MilliporeSigma will provide end-to-end testing services designed to support the safe and consistent commercial release of Genetix’s therapies. The companies have already spent years jointly developing and validating specialized testing methods tailored for advanced genetic medicines.
“At Genetix Biotherapeutics, we are focused on scaling our commercial operations to expand access to our transformative genetic therapies as demand continues to grow”, said Brian Riley, President and Chief Technical Officer.
“That requires a testing partner with deep technical expertise, proven commercial-scale execution and broad geographical reach. Beyond capabilities, sharing a patient-centric mindset makes MilliporeSigma a natural fit as we work together to deliver one-time curative therapies reliably and consistently to patients who need them most.”
MilliporeSigma said the partnership highlights the growing importance of sophisticated testing infrastructure as the biotech industry shifts from traditional biologics toward next-generation therapies such as gene and cell treatments.
Its BioReliance platform now includes advanced technologies such as Blazar for rapid virus detection and Aptegra, a validated genetic stability assay designed to streamline testing for novel therapies.
