Merck has announced a new five-year agreement with Genetix Biotherapeutics to provide analytical and biosafety release testing services for the company's portfolio of FDA-approved gene therapies.
The agreement covers three FDA-approved gene therapies, developed by Genetix, for the treatment of sickle cell disease, β-thalassemia and cerebral adrenoleukodystrophy.
The therapies are designed as one-time treatments that target the underlying causes of the life-limiting rare diseases.
"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.
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.
"At Genetix Biotherapeutics, we are focused on scaling our commercial operations to expand access to our transformative genetic therapies as demand continues to grow," added 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 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.
The partnership builds on more than a decade of collaboration between the pair.