SCTbio and Fortrea Form Strategic Partnership to Accelerate Cell and Gene Therapy Development
核心洞察
SCTbio (搜索), a leading European CDMO specializing in GMP manufacturing for cell-based products, and Fortrea (搜索), a global CRO, announced a strategic collaboration to streamline cell and gene therapy (搜索) development.
The partnership aims to harmonize clinical trial logistics with GMP manufacturing readiness, creating synchronized solutions to de-risk programs and accelerate timelines from first-in-human trials to commercialization.
With over 4,400 gene, cell and RNA therapies (搜索) currently in development according to The American Society of Cell & Gene Therapy (搜索), the collaboration addresses critical bottlenecks in advanced therapy development.
SCTbio (搜索), a leading European contract development and manufacturing organization (CDMO) specializing in GMP manufacturing for cell-based products, and Fortrea (搜索), a global contract research organization (CRO), announced a strategic collaboration agreement on December 4, 2025. The partnership is designed to streamline development processes, accelerate timelines, and bring advanced therapies to patients faster by creating synchronized solutions across the entire development lifecycle.
Addressing Critical Industry Bottlenecks
The collaboration comes at a pivotal time for the cell and gene therapy (搜索) sector, with The American Society of Cell & Gene Therapy (搜索) reporting more than 4,400 gene, cell and RNA therapies (搜索) currently in development. This partnership represents a forward-looking model for how CDMOs and CROs can work together to deliver synchronized solutions that help de-risk programs, streamline planning, expedite study setup, and optimize cost-efficiency.
"By combining Fortrea (搜索)'s global clinical reach with SCTbio (搜索)'s manufacturing expertise in cell therapy (搜索), viral vectors (搜索) and apheresis, we're creating a framework for smarter protocol design, more resilient supply chains and faster, safer delivery of therapies to patients worldwide," said Luděk Sojka, CEO of SCTbio. "We share the same vision: that early alignment between CDMO and CRO can transform complexity into opportunity."
Synchronized Manufacturing and Clinical Development
The strategic alliance will harmonize clinical trial logistics with GMP manufacturing readiness, ensuring that cell and gene therapy (搜索) programs benefit from synchronized planning and execution. The companies will work closely with clients to evaluate and optimize pathways from early-stage development through first-in-human trials, later-stage clinical advancement, and geographical expansions.
Mark Morais, chief operating officer and president of Fortrea (搜索) Clinical Development, emphasized the collaboration's potential impact: "Our collaboration with SCTbio (搜索) represents a significant step forward in enhancing the cell and gene therapy (搜索) ecosystem. This collaboration is structured to empower customers with the right resources and relevant experience needed to accelerate their therapies from first-in-human trials to commercialization."
Complementary Expertise and Global Reach
SCTbio (搜索) brings over 15 years of experience in cell therapy (搜索) manufacturing, delivering end-to-end GMP services from apheresis materials and vector production to process development, manufacturing, quality control, release, storage, and logistics. As a member of the PPF Biotech Group (搜索), SCTbio specializes in Advanced Therapy Medicinal Products (ATMPs) and guides clients through every stage of clinical and commercial development.
Fortrea (搜索) contributes three decades of experience spanning more than 20 therapeutic areas, providing phase I-IV clinical trial management, clinical pharmacology, and consulting services. The company operates in approximately 100 countries with a diverse team scaled to deliver focused and agile solutions to customers globally.
Setting New Standards for Advanced Therapy Development
By uniting Fortrea (搜索)'s deep development experience from first-in-human studies to product approval with SCTbio (搜索)'s specialized manufacturing and release capabilities, the partnership aims to set a new benchmark for operational excellence in advanced therapy development. The collaboration addresses the most pressing challenges in developing advanced therapies by ensuring early alignment between manufacturing and clinical development teams.
This strategic partnership positions both companies to better serve the growing demand for cell and gene therapies while addressing the complex logistical and regulatory challenges that have historically slowed the development of these innovative treatments.