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The King Faisal Specialist Hospital & Research Center (KFSHRC) and Germfree Laboratories agreed to partner to develop Saudi Arabia’s first fully integrated, modular advanced therapy Medicinal product (ATMP) manufacturing campus.
The new facility will be located at KFSHRC’s main campus in Riyadh and will serve as a milestone in advancing Vision 2030 and the National Biotechnology Strategy, two initiatives aimed at transforming the Kingdom into a global hub for life sciences and biomanufacturing, and to become a global biotech hub by 2040.
Fast-track project
“This initiative marks a historic milestone, not just for our institution, but for the Kingdom of Saudi Arabia in alignment with Vision 2030 and the National Biotechnology Strategy,” said His Excellency Majid bin Ibrahim Al Fayyad, MBBS, CEO of KFSHRC. “With Germfree as our partner, we are creating a world-class advanced therapies campus that will accelerate access to transformative treatments, draw the brightest minds in science, and strengthen Saudi Arabia’s position as a global leader in biotechnology.
“This fast-track, strategic project represents a continuation of the long history of healthcare innovation that has been realized by King Faisal Specialist Hospital and Research Center.”
“KFSHRC’s leadership and vision align with Germfree’s mission to expand access to complex therapies through future-proofed, agile infrastructure,” added Kevin Kyle, CEO of Germfree Laboratories. “Together, we are building much more than a facility for cell & gene therapy manufacturing; we’re building a turnkey, scalable platform for discovery and delivery of curative therapies for the people of Saudi Arabia, the Middle East, and beyond. This collaboration reflects the critical role infrastructure plays in unlocking access to advanced therapies, and we are proud to support KFSHRC’s vision for patient-centric care.”
The turnkey project is expected to fast-track the Kingdom’s ability to manufacture cell and gene therapies locally, host international clinical trials, and attract leading pharmaceutical partnerships and scientific talent from around the world.
Driving Saudi Arabia’s global biotech vision
This project directly supports Saudi Arabia’s National Biotechnology Strategy, launched to localize vaccine and therapeutic production, develop sovereign biomanufacturing capabilities, and establish the Kingdom as a global biotechnology leader by 2040.
As a core pillar of Vision 2030, the strategy aims to make Saudi Arabia a destination for clinical trials, scientific discovery, pharmaceutical investment, and biotech entrepreneurship across the Middle East and beyond.
The ATMP Manufacturing Campus will be delivered as a fully CGMP-compliant, off-site built, modular solution, developed in strategic phases to support immediate clinical impact and long-term growth. The project will begin with the deployment of Germfree’s BioGO® Box single-module cleanroom solution, enabling early operator training, tech transfer, and R&D activities.
In parallel, a newly constructed facility will be built centrally on the KFSHRC campus to house prefabricated modular cleanroom clusters, providing 16 production suites, each designed for multi-modal CGT production supporting both clinical and commercial-scale manufacturing. Full operational readiness will be reached just 18 months after contract signing, roughly half the timeline of a conventional stick-built facility of comparable scope.
That speed, combined with the flexibility to scale or repurpose suites as new therapies emerge, means Saudi patients will gain access to advanced treatments years sooner than traditional construction would allow, according to Kyle.
The facility will be constructed to meet SFDA, FDA, EMA, and BMBL requirements and will include a fully integrated digital manufacturing platform designed to support smart, data-driven CGMP operations.
