Unveiled at BIO 2025 in Boston, the project marks a major step toward Saudi Arabia's goal to become a global biotechnology hub by 2040.
BOSTON, June 17, 2025 /PRNewswire/ -- BIO International Convention 2025 -- At the BIO International Convention 2025 in Boston, King Faisal Specialist Hospital & Research Centre (KFSHRC) and Germfree Laboratories, LLC announced a strategic partnership 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 critical milestone in advancing Vision 2030 and the National Biotechnology Strategy, two national initiatives aimed at transforming the Kingdom into a global hub for life sciences, biomanufacturing, and to become a global biotech hub by 2040.
"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 Dr. Majid bin Ibrahim Al Fayyadh, 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 Centre."
"KFSHRC's leadership and vision align with Germfree's mission to expand access to complex therapies through future-proofed, agile infrastructure," said 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."
Under the terms of a signed Letter of Intent, the turnkey project will 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 Vision for Global Biotech Leadership
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.
By establishing a globally competitive manufacturing campus, KFSHRC is not only advancing national healthcare; it is setting a new global standard for innovation, scalability, and patient-centered care.
A Smart, Scalable Biomanufacturing Platform
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.
The state-of-the-art facility will meet SFDA, FDA, EMA, and BMBL requirements and will include a fully integrated digital manufacturing platform designed to support smart, data-driven CGMP operations from day one.
Germfree's continued growth is supported by EW Healthcare Partners, a leading private equity company that makes growth equity investments in fast-growing commercial-stage healthcare companies in the pharmaceutical, medical device, diagnostics, and technology-enabled services sectors in the United States and Europe.
About King Faisal Specialist Hospital & Research Centre (KFSHRC)
King Faisal Specialist Hospital & Research Centre is Saudi Arabia's foremost tertiary-and-quaternary referral institution, delivering world-class care in oncology, transplantation, cardiovascular medicine and precision therapeutics. It is ranked No. 1 in the Middle East & Africa and 15th globally among academic medical centers by Brand Finance's 2025 report and is listed on Newsweek's World's Best Hospitals as well as World's Best Smart Hospitals 2025. As a flagship partner in the Kingdom's Vision 2030 and National Biotechnology Strategy an initiative to localize biomanufacturing and make Saudi Arabia a global biotech hub by 2040, KFSHRC forges international collaborations, drives cutting-edge clinical research, and cultivates Saudi scientific talent to expand patient access to life-changing therapies.
About Germfree Laboratories
Germfree advances ATMP development and point-of-care manufacturing by delivering U.S-designed and built, ready-to-operate modular and mobile CGMP cleanrooms, integrated equipment, and lifecycle services under a single contract. Today, more than 200 Germfree laboratories, cleanrooms, and complex equipment systems operate in 32 countries, underscoring the company's commitment to innovative, agile, integrated, and impactful research and biomanufacturing worldwide. Strategic partnerships with process-technology leaders and in-country service firms ensure every deployment arrives fully validated, operationally ready, and regulatory compliant from day one. The company's U.S. manufacturing hub and on-site service programs ensure rapid deployment, sustained performance, knowledge transfer to local workforces and a continuous pipeline of innovation that keeps facilities future ready as advanced therapies evolve.
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