Germfree and KFSHRC to bolster Saudi Arabia's influence in the cell and gene therapy space

Published: 19-Jun-2025

The project will expand the Kingdom's the cell and gene therapy manufacturing infrastructure, while strengthening the country's global biopharmaceutical presence

At BIO International, Germfree Laboratories announced a strategic collaboration with King Faisal Specialist Hospital & Research Centre (KFSHRC).

Together, they will build Saudi Arabia's first advanced therapy medicinal product (ATMP) manufacturing campus, which will be located at KFSHRC's main campus in Saudi's capital city, Riyadh.

The project will result in the development of a fully cGMP-compliant modular solution, with the first stage being the deployment of Germfree's BioGO Box single-module cleanroom solution.

Meanwhile, a newly constructed facility will be built in the heart of the KFSHRC campus, which will house prefabricated modular cleanroom clusters, providing 16 production suites.

All of these suites will be suitable for cell and gene therapy production in a wide range of modalities, supporting both clinical and commercial-scale manufacturing.

The site will also incorporate a fully-integrated digital manufacturing platform, which will streamline the process through data-driven insights.

The collaboration will serve as a key milestone in advancing Vision 2030 — as well as the National Biotechnology Strategy — which both aim to transform the Kingdom into a global hub for biomanufacturing, biotech and life science companies.

Under the terms of a signed letter of intent, the project will focus on fast-tracking Saudi Arabia's ability to manufacture cell and gene therapies, while also boosting the country's capacity to host international clinical trials.

The partnership also aims to attract leading pharmaceutical partnerships and scientific talent from around the world — positioning Saudi as a premier destination for scientific discovery, clinical trials, pharmaceutical manufacturing and biotech entrepreneurship across the Middle East.

Germfree’s continued growth is supported by private equity company EW Healthcare Partners, which supports pharmaceutical, medical device and diagnostics companies across the US and Europe.
“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.”

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