The parties have signed a memorandum of understanding in that respect.
The rollout of the mobile processing units and labs (OMPULs) within the state of California will be staggered.
The first stage involves establishing and validating an OMPUL at UC Davis, anticipated to be within the first 12 months following execution of a definitive agreement between the parties.
Thereafter, both parties will agree upon and develop a decentralized model of OMPUL placement in compliance with regulatory requirements, as well as commercialize and install OMPULs at other healthcare sites in California.
The intent is to enable the development and manufacture of cell and gene therapies from Orgenesis, its partners, and UC Davis’ partners.
Decentralized CGT manufacturing
“The cell and gene therapy sector continues to expand and develop solutions for patients suffering from a range of conditions. However, despite the sector maturing, there is still yet to be drawn a clearly defined roadmap to enable patients to reach and benefit from these life-saving therapies. Orgenesis has designed its OMPULs to decentralize manufacturing and enable cell and gene therapies to be developed on the site of universities, hospitals, and healthcare providers, with the goal of reducing the costs of developing these therapies. This is vital to make the widespread delivery of life-saving therapies to patients a reality. As a result, Orgenesis, through its subsidiary Morgenesis, is installing OMPULs in the US and internationally,” said Vered Caplan, CEO, Orgenesis.
“It is anticipated that this partnership with UC Davis and the universities across California will provide decentralized development and manufacturing of CGTs across a major US healthcare state. This could result in the development of CGTs to patients across a range of conditions at a cost that can be supported by payers and the wider society as a whole,” she added.
UC Davis originally signed a collaboration agreement to join Orgenesis’ POCare Network in January 2020, with UC Davis Health since utilizing that company's POCare platform to develop, commercialize and supply cell and gene products and therapies.
The Maryland biotech leverages its POCare Platform to identify promising new cell and gene therapies and guide them through development to treat patients at a lowered cost. The platform is comprised of three enabling components: a pipeline of licensed POCare Therapeutics that are processed and produced in closed, automated POCare Technology systems across a collaborative POCare Network, which brings together patients, doctors, industry partners, research institutes and hospitals worldwide.
Last year, Caplan told BioPharma-Reporter about the advantages of its decentralized POCare model.
“From around 2015 to 2016, there were ad nauseum debates in terms of ‘centralized’ versus ‘decentralized’ processing of cell and gene therapies at industry events and conferences.
“We, at Orgenesis, had had a pioneering experience with a centralized structure through one of our subsidiaries. We knew this type of model was safe and effective but not efficient enough to truly scale autologous therapies. Therefore, in 2020, we transitioned to a decentralized model through the creation of our proprietary POCare platform. We enabled decentralized processing to go from the theoretical realm to reality.
“Initially, we started working within hospitals themselves, but due to some structural inefficiencies, we realized it would not be possible to achieve meaningful scale. We identified the lack of uniform processing environments in different hospitals as a major barrier to success. This realization led us to innovate our Orgenesis Mobile Processing Units and Labs (OMPULs).
“Bringing this solution to the market allows CGT companies as well as hospitals the first real new option in quite some time. Now, when they are deciding whether to build or expand their facility/infrastructure, or to outsource to a solutions provider, they have the further option to choose, or combine their traditional centralized production with, our decentralized POCare model.”