Merck has announced a 5-year agreement with Genetix Biotherapeutics to provide analytical and biosafety release testing services for its portfolio of FDA-approved gene therapies.

The agreement covers three FDA-approved gene therapies developed by Genetix to treat sickle cell disease, β-thalassemia, and cerebral adrenoleukodystrophy. These therapies are designed as one-time treatments that target the underlying causes of serious, life-limiting rare diseases.

Paolo Carli, Head of Advanced Solutions for the Life Science business, Merck, said, “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. With more than 75 years of specialised expertise in these areas, we are the innovation partner for customers at their most complex points in the development and commercialisation of novel modalities.”

The partnership builds on over a decade of collaboration between Merck and Genetix, including the joint development and validation of specialised test methods to support the release and commercialisation of advanced therapies. Merck’s end-to-end testing services for novel modalities include analytical and bioassay testing, biosafety testing, viral clearance studies and cell banking services, helping customers meet development and release requirements while supporting the safety, consistency and reliability of their therapies.

Brian Riley, President and Chief Technical Officer, said, “At Genetix Biotherapeutics, we are focused on scaling our commercial operations to expand access to our transformative genetic therapies as demand continues to grow. 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 the life science business of Merck a natural fit as we work together to deliver one-time curative therapies reliably and consistently to patients who need them most.”

From established biologics to novel modalities, customers need deep scientific expertise, integrated capabilities and reliable testing infrastructure to move from development to commercialisation with confidence. Merck’s commitment to advancing testing innovation is reflected in the continuous expansion of its BioReliance portfolio, which includes next-generation testing platforms such as Blazar for rapid virus detection and Aptegra, an all-in-one, validated genetic stability assay.