In a statement, the Germantown, Maryland-based company, said that under the terms of the agreement, UC Davis Health will utilize Orgenesis’ point-of-care platform to develop, commercialize and supply cell and gene products and therapies.
The point-of-care platform is designed to enable hospitals to implement Orgenesis’ proprietary automated, closed systems and know-how to collect, process and supply cells within the patient care setting for various treatments.
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The first collaboration under the deal involves scaling up and integrating UC Davis’ lentiviral vector process as part of the Orgenesis point-of-care network platform for the development of cell and gene therapies for treating patients, said the company.
Creating affordable cell, gene-based products
According to the company, the UC Davis GMP facility has developed a small-intermediate scale, high-quality vector process that has been successfully utilized to manufacture lentiviral vectors in several clinical trials, including the manufacturing of CAR T cell therapies. Its point-of-care network, which combines processing and therapeutic technologies, is designed to allow for the efficient production of high quality, affordable cell, and gene-based products.
On successfully completing the collaboration, Orgenesis and UC Davis plan to pursue the commercialization of the technology and expand the processing and supply of their products under development at the UC Davis site. Lentivirus is a family of viruses that insert their DNA into the host cells' genome. Lentiviral vectors are increasingly utilized in cell and gene therapy as a method for inserting, modifying, or deleting specific genes within cells.
“We are delighted to add UC Davis to our point-of-care network, which will allow us to collaborate with the university to develop and supply therapeutics within the point-of-care setting in general and specifically in our need for virus supply,” said Orgenesis CEO Vered Caplan.
Addressing shortages of lentiviral vectors
Orgenesis' boss said she looked forward to leveraging the company’s point-of-care platform to assist UC Davis in expanding its ability to address the worldwide shortages of lentiviral vectors.
“Their new system is designed to address the global need for a more efficient, large scale vector manufacturing processes in an efficient manner. We believe this partnership further validates the significant value proposition of our point-of-care,” said Caplan.
For the fiscal third quarter ended September 30, Orgenesis generated meaningful revenue, over $1 million, through its rapidly advancing point-of-care cellular therapy platform.
“We, at UC Davis Health, in the Stem Cell Program and in the GMP Facility, are committed to bringing these novel cell and gene therapy based treatments to patients in need and making them affordable,” said Adjunct Professor Gerhard Bauer, director of the GMP Facility, at UC Davis.
“We look forward to leveraging Orgenesis’ expertise to accelerate the development and commercialization of our lentiviral vector manufacturing system, which addresses a significant unmet need in the market for an efficient and scalable manufacturing process,” said Professor Jan A Nolta, director of the Stem Cell Program and the Gene Therapy Center at UC Davis Health.
Orgenesis Inc, a leading cell and gene therapy enabling company provides centralized contract development and manufacturing organization (CDMO) services, as well as localized point-of-care development and processing centers through its subsidiary Orgenesis Maryland Inc.
Contact the author Uttara Choudhury at [email protected]
Follow her on Twitter: @UttaraProactive