- SCTbio and Fortrea have entered a strategic collaboration to align GMP manufacturing and clinical development for cell and gene therapies.
- The partnership aims to streamline planning, reduce programme risk and accelerate progression from early development to clinical trials and commercialisation.
SCTbio has formed a strategic collaboration with Fortrea to integrate GMP manufacturing and clinical development for cell and gene therapies. The companies stated that the partnership is designed to streamline development pathways, reduce programme complexity and support faster delivery of advanced therapies to patients.
The collaboration brings together SCTbio’s experience in GMP manufacturing for cell-based products, viral vectors and apheresis with Fortrea’s global clinical trial capabilities. According to the announcement, this integrated model is intended to de-risk development programmes, harmonise planning and improve cost-efficiency across the therapy lifecycle.
The agreement also addresses the growing volume of advanced therapies in development. More than 4,400 gene, cell and RNA therapies are currently in the pipeline, highlighting the need for aligned CDMO and CRO approaches to support progression from early-stage research to first-in-human trials and beyond.
“By combining Fortrea’s global clinical reach with SCTbio’s manufacturing expertise in cell therapy, viral vectors and apheresis, we’re creating a framework for smarter protocol design, more resilient supply chains, and faster, safer delivery of therapies to patients worldwide.”
Luděk Sojka, CEO of SCTbio
Mark Morais, Chief Operating Officer and President of Fortrea Clinical Development, said the collaboration is intended to equip customers with the expertise required to accelerate therapies from early clinical studies to commercial readiness.
The companies will work together to coordinate clinical logistics with manufacturing readiness, supporting seamless transitions between development phases and geographical expansion. This partnership aims to establish a new operational standard for advanced therapy development by combining Fortrea’s end-to-end clinical experience with SCTbio’s specialist manufacturing and release capabilities.
