Germfree acquires Orgenesis tech, inks deal to advance cell therapies

Germfree, a cleanroom services and equipment firm, will acquire five of Orgenesis’ mobile shipping containerized cleanrooms, known as OMPULs, along with the technology necessary to produce these units and the associated quality management system tailored for the decentralized model.

Orgenesis, meanwhile, will tap Germfree to accelerate the availability of its own cell and gene therapies (CGTs), particularly in immuno-oncology, with an aim to boost production capacity to meet urgent patient demand.

“We believe that decentralized cell processing offered through OMPULs could potentially democratize supply, increase production capacity, simplify logistics and shorten turnaround time,” Vered Caplan, CEO, Orgenesis told BioProcess Insider.

“Specifically, decentralized production using mobile units like OMPULs places cell processing at or near the site of care, reducing logistical barriers and costs. This model enhances global accessibility by facilitating quick setup and operation of highly standardized processing facilities across various geographical locations, directly addressing local needs with Germfree's robust infrastructure.”

Additionally, Orgenesis will provide Germfree OMPULization services — adapting CGTs for processing in a decentralized environment. This encompasses analytical development, alongside processing services, to ensure that each decentralized unit operates with the highest standards of quality and efficiency, in compliance with regulatory requirements.

Initially focusing on integrating Orgenesis' OMPULs into Germfree's established manufacturing framework, the partnership will also co-market the Octomera service platform, OMPULs, and commence the production of OMPULs for new clients.

“Together with Orgenesis, we are leveraging our combined technology assets to develop a digital manufacturing platform, featuring quality management systems,” said Carol Houts, chief scientific officer of GermFree.

“This initiative will capitalize on Germfree's expertise in remote monitoring of autonomous cleanrooms to enhance oversight and quality control. We expect these efforts to significantly improve the efficiency and reliability of our CGT production processes.”