MilliporeSigma Secures Exclusive Five-Year Testing Agreement for Genetix Biotherapeutics' FDA-Approved Gene Therapies
核心洞察
MilliporeSigma (搜索) has entered a five-year exclusive agreement to provide comprehensive analytical and biosafety testing services for Genetix Biotherapeutics (搜索)' three FDA-approved gene therapies (搜索).
The partnership covers gene therapies (搜索) treating sickle cell disease (搜索), β-thalassemia (搜索), and cerebral adrenoleukodystrophy (搜索), all designed as one-time curative treatments for rare diseases.
This collaboration builds on more than a decade of partnership between the companies, reinforcing MilliporeSigma (搜索)'s role in supporting commercial-scale gene therapy manufacturing.
MilliporeSigma (搜索), the U.S. and Canada Life Science business of Merck KGaA, has announced a five-year exclusive agreement with Genetix Biotherapeutics (搜索) to provide end-to-end analytical and biosafety release testing services for the company's portfolio of FDA-approved gene therapies (搜索). The partnership represents a significant expansion of commercial testing infrastructure for advanced therapeutic modalities.
Comprehensive Testing Services for Rare Disease Therapies
The agreement encompasses three FDA-approved gene therapies (搜索) developed by Genetix to treat sickle cell disease (搜索), β-thalassemia (搜索), and cerebral adrenoleukodystrophy (搜索). These therapies are designed as one-time treatments that target the underlying causes of serious, life-limiting rare diseases.
"As cell and gene therapies (搜索) 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."
Strategic Partnership for Commercial Scaling
The collaboration addresses Genetix Biotherapeutics (搜索)' need to scale commercial operations as demand for their transformative genetic therapies continues to grow. Brian Riley, President and Chief Technical Officer of Genetix Biotherapeutics, emphasized the importance of selecting a testing partner with comprehensive capabilities.
"That requires a testing partner with deep technical expertise, proven commercial-scale execution and broad geographical reach," Riley stated. "Beyond capabilities, sharing a patient-centric mindset makes MilliporeSigma (搜索) a natural fit as we work together to deliver one-time curative therapies reliably and consistently to patients who need them most."
Decade-Long Collaboration Foundation
The partnership builds on more than a decade of collaboration between MilliporeSigma (搜索) and Genetix, including the joint development and validation of specialized test methods to support the release and commercialization of advanced therapies. This established relationship has enabled the development of customized testing protocols specifically designed for gene therapy products.
MilliporeSigma (搜索)'s comprehensive testing services for novel modalities include analytical and bioassay testing, biosafety testing, viral clearance studies and cell banking services. These services help customers meet development and release requirements while supporting the safety, consistency and reliability of their therapies.
Advanced Testing Infrastructure
The company'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. These advanced platforms are designed to meet the unique requirements of cell and gene therapy manufacturing.
MilliporeSigma (搜索) operates more than 55 total manufacturing and testing sites worldwide, with a portfolio of more than 300,000 products focused on scientific discovery, biomanufacturing and testing services. The company's global infrastructure provides the geographical reach necessary to support commercial-scale gene therapy distribution.