Decentralized manufacturing as a service is an emerging trend in the gene and cell therapy industry. According to Ori Biotech, exponential growth in the cell and gene therapy industry is driving this trend–with early-stage companies wanting to scale up.
“They either need to go to a CDMO or they have to build their own facility,” explains Jason C. Foster, CEO of Ori Biotech. “There isn’t enough [CDMO] capacity out there, it’s expensive, and they lose control of their processes, or they have to build their own facility maybe three years in advance and may never move into it.”
The company says they’ve developed a cloud-based automated manufacturing platform, which can be purchased as pieces of equipment for academic research work, or as a mobile cleanroom space for scaled-up manufacturing.
“We’re building Ori to be cloud-native, [i.e.] to connect in real-time to the cloud, structure, and aggregate [data], and then apply machine learning to understand [and receive] feedback on] processes in real-time,” says Foster.
The company, he says, developed its manufacturing platform from the ground up rather than merely repurposing existing technologies to suit the gene and cell therapy industry. After being R&D focused, he says they’re currently transitioning to a commercial organization and hope to launch their first products in about 14 months.
“We don’t want to be a CDMO, but we can supply the infrastructure and technology that underpins CDMOs and to allow the industry to work more flexibly,” notes Foster, who adds that companies will be able to lease or buy the equipment, and scale up production, as necessary.
He hopes to submit the manufacturing platform’s regulatory package to the FDA by the second half of 2022, and to double his 33-strong workforce to 70 by the end of that year.