King Faisal Specialist Hospital & Research Centre (KFSHRC) has announced a strategic partnership with Germfree Laboratories to establish Saudi Arabia’s first fully integrated, modular advanced therapy medicinal product (ATMP) manufacturing campus.
Germfree Laboratories is a US-based specialist in the design and manufacture of turnkey, modular cleanroom facilities for biopharmaceutical and advanced therapy manufacturing.
King Faisal Specialist Hospital & Research Centre is Saudi Arabia’s leading tertiary and quaternary referral institution, renowned for its expertise in oncology, transplantation, cardiovascular medicine, and precision therapeutics.
The announcement was made at the BIO International Convention 2025 in Boston, US.
King Faisal Specialist Hospital & Research Centre has announced a strategic partnership with Germfree Laboratories to establish Saudi Arabia’s first fully integrated, modular advanced therapy medicinal product manufacturing campus
The new facility is to be located at KFSHRC’s main campus in Riyadh, and is set to become a critical pillar in delivering Saudi Arabia’s Vision 2030 and the National Biotechnology Strategy.
Both initiatives aim to position the Kingdom as a leading global biotechnology hub by 2040 through investment in life sciences, biomanufacturing and advanced therapies.
His Excellency Dr Majid bin Ibrahim Al Fayyadh, CEO of KFSHRC, said: “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.
“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.”
The new facility, to be located at KFSHRC’s main campus in Riyadh, is set to become a critical pillar in delivering Saudi Arabia’s Vision 2030 and the National Biotechnology Strategy
The project will fast-track the Kingdom’s capacity to manufacture cell and gene therapies domestically, host international clinical trials, and attract pharmaceutical partnerships and scientific talent from across the globe.
Under the terms of a signed letter of intent, Germfree will deliver a phased, turnkey modular biomanufacturing solution.
A fast-track, modular cleanroom platform
The ATMP manufacturing campus will be delivered as a fully CGMP-compliant, off-site prefabricated modular platform.
It will initially deploy Germfree’s BioGO (registered trademark) Box single-module cleanroom system to support operator training, technology transfer, and early-stage R&D.
Subsequently, a new centralised facility on the KFSHRC campus will house prefabricated cleanroom clusters, comprising 16 production suites designed for multi-modal cell and gene therapy production at both clinical and commercial scale.
This modular, phased approach offers significant advantages in speed and adaptability.
Under the terms of a signed letter of intent, Germfree will deliver a phased, turnkey modular biomanufacturing solution
Full operational readiness is anticipated just 18 months after contract signing, approximately half the time required for a conventional, stick-built facility of similar scope.
The facility will be built to meet SFDA, FDA, EMA and BMBL standards and will feature an integrated digital manufacturing platform to support smart, data-driven CGMP operations from inception.
Kevin Kyle, CEO of Germfree Laboratories, said: “KFSHRC’s leadership and vision align with Germfree’s mission to expand access to complex therapies through future-proofed, agile infrastructure.
“Together, we are building much more than a facility for cell and gene therapy manufacturing, we are establishing a scalable platform for discovery and delivery of curative therapies for the people of Saudi Arabia, the Middle East, and beyond.”
Driving Vision 2030’s biotechnology ambitions
This development is intended to directly support Saudi Arabia’s National Biotechnology Strategy, which aims to localise vaccine and therapeutic production, develop sovereign biomanufacturing capabilities, and establish the Kingdom as a biotechnology centre of excellence.
