UC Davis and Orgenesis Inc. today announced an agreement to implement Orgenesis Mobile Processing Units and Labs™ (OMPULs™) at multiple medical and academic institutions within the University of California. These OMPULs provide on-site development and manufacturing of cell and gene therapies, help reduce development costs, and increase access to therapeutics.
“We are very excited to move forward with this collaboration with Orgenesis,” said Jan Nolta, director of the UC Davis Stem Cell and Gene Therapy Center Program at the UC Davis Health Institute for Regenerative Care. “OMPULs will enable broader access to promising cell and gene therapies for patients in different regions of California, improving affordability and reducing health care disparities.”
The collaboration is the first step in bringing affordable therapies to patients in California. Defines a step-by-step approach to deploy and manage OMPUL using the Point-of-Care (POCare) services platform to produce cell and gene therapies on-site for clinical trials and hospital therapies.
UC Davis Health joined the Orgenesis POCare Network in 2020. It has used the platform to develop and deliver cell and gene products and therapies.
Access to cell and gene therapy through on-site manufacturing
Over the past three decades, the field of cell and gene therapies has transformed, with applications expanding every year. One example is chimeric antigen receptor T (CAR T) cell therapies. These have evolved from being experimental in 2012, with therapies available in only a few specialized academic centers, to FDA-approved marketed therapies now available to more patients.
CAR T cells are applied as first-line therapies to treat hematologic malignancies (blood cancer disorders). They give thousands of patients hope that their immune systems can be trained to successfully fight their lymphomas or leukemias for the rest of their lives.
“CAR T cell therapies are currently the best known cell and gene therapies,” said Gerhard Bauer, director of the Good Manufacturing Practice facility at UC Davis. “What is still missing, however, are CAR T-cell therapies that are widely available and affordable, so all patients, no matter where they are, could receive such curative treatments.”
UC Davis worked with Orgenesis on a paradigm shift to address these accessibility issues. Instead of a few large manufacturing centers, mobile cell manufacturing and gene therapy units will be able to deliver CAR T cell products to patients in locations far from major universities or medical centers.
OMPULs will enable broader access to promising cell and gene therapies for patients in different regions of California, improving affordability and reducing health care disparities.
The new partnership includes the creation and validation of the first OMPUL at UC Davis. This step would be followed by the commercialization and installation of OMPUL at other healthcare sites in California.
“We believe this partnership between Orgenesis, UC Davis and the University of California will become a model for decentralizing the development and manufacturing of cell and gene therapies while demonstrating the benefits of our OMPUL project for the US and international healthcare markets.” said Vered Caplan, CEO of Orgenesis. “Our shared goal is the widespread development of life-saving therapies for patients with a range of conditions, at a cost that can be borne by taxpayers and society at large.”
Morgenesis LLC., subsidiary of Orgenesis’ POCare service, will install OMPULs.
“Quality products for the treatment of blood cancers will become more available. The production will be carried out by highly qualified personnel and supervised by a centralized and sophisticated quality control unit, just like in large production centers,” said Bauer. “With OMPULs, it is possible to avoid cell storage and product shipping and reduce product production time. This leads to cost savings by making therapies more affordable and available to more patients.”
The new agreement with Orgenesis follows the renewal of an $8 million grant to UC Davis Health’s Alpha Stem Cell Clinic from the California Institute for Regenerative Medicine (CIRM). The grant allows the clinic to expand its clinical trial operations and advance toward on-site manufacturing of therapies.
Learn about the UC Davis Stem Cell Program
UC Davis’ Stem Cell program brings together physicians, researchers, biomedical engineers, and a range of experts and partners at its Institute for Regenerative Cures. The $62 million facility located on the University of Sacramento campus was supported by the California Institute for Regenerative Medicine (CIRM). It is the hub for team-driven, collaborative science that is driving breakthrough discoveries designed to bring stem cell therapies and cures to patients around the world. Learn more about the CIRM-funded Alpha Clinic at UC Davis Health.
About the Gene Therapy Center
The UC Davis Gene Therapy Center provides a unique, comprehensive, and well-established interdisciplinary network of experts and resources to lead the field of gene therapy through research, manufacturing, education, and policy. It offers expertise and state-of-the-art facilities and equipment, including one of the largest university Good Manufacturing Practice (GMP) facilities and a Viral Vector Core. Learn more about the Gene Therapy Center.
Orgenesis is a global biotechnology company working to unlock the full potential of cell and gene therapies (CGT) in an affordable and accessible format at the point of care. The POCare network brings together patients, physicians, industrial partners, research institutions and hospitals from around the world to achieve harmonized and regulated clinical development and manufacturing of therapies. Learn more about Orgenesis.
#Davis #Orgenesis #Partner #Increase #Access #Cell #Gene #Therapies #California