Orgenesis Inc., a global biotech company, and the University of California, Davis (UC Davis) have announced a partnership to deploy Orgenesis Mobile Processing Units and Labs (OMPULs) at medical and academic institutions within the University of California system.
The agreement outlines a phased approach where Orgenesis will install and operate OMPULs, enabling their proprietary point-of-care (POCare) Service Platform to manufacture therapeutics at hospitals across California. This will facilitate onsite production for clinical trials, such as the cell and gene therapies being developed at UC Davis Health’s Alpha Stem Cell Clinic.
The first OMPUL will be established and validated at UC Davis, followed by a decentralized model of placement to commercialize and install OMPULs at other healthcare sites within California. These units will enable point-of-care treatment through the development and manufacture of cell and gene therapies from Orgenesis, its partners, and UC Davis’ partners, subject to further agreements.
Vered Caplan, CEO of Orgenesis, expressed optimism that the partnership will serve as a blueprint for decentralizing the development and manufacturing of cell and gene therapies (CGTs), showcasing the benefits of their OMPUL design for the US and international healthcare markets.
The shared goal is the widespread development of life-saving CGTs for patients with a range of conditions, at a cost that can be supported by payers and the wider society.
Jan Nolta, director of the Stem Cell Program and the Gene Therapy Center at UC Davis Health’s Institute for Regenerative Cures, also expressed excitement about the collaboration, noting that the OMPULs will allow wider access to promising cell and gene therapies for patients in different regions of California, improving accessibility and reducing healthcare disparities.
The agreement was signed by Orgenesis POC CA Inc., a Delaware Corporation incorporated by Morgenesis, and The Regents of the University of California, on behalf of its Davis campus. UC Davis Health has been utilizing Orgenesis’ POCare Service Platform to develop and supply cell and gene products and therapies since joining the Orgenesis POCare Network in 2020.
The POCare Network enables hospitals to expand their capacity to supply cell therapies at the point-of-care site for the treatment of patients. The first collaboration involved scaling up and integrating UC Davis’ lentiviral vector process for localized development and processing of cell and gene therapies for treating patients.
The latest agreement follows an $8 million grant renewal from the California Institute for Regenerative Medicine (CIRM) in December 2022 for UC Davis Health’s Alpha Stem Cell Clinic. The grant enables the clinic to expand its clinical trials operation and advance toward onsite manufacturing of therapies.