According to their 2020 investor filing, Orgenesis is finalizing the development of more than 30 processing locations worldwide for their mobile production units, which aim to bring advanced therapy manufacturing to the point-of-care (POC).

“We’re still finalizing things, but we have a point-of-care platform and have built up our point-of-care [processing] centers,” explains Vered Caplan, the company’s CEO, who spoke about her decentralized business model to GEN last year.

Orgenesis’ business model involves working in partnership with hospital research centers and small biotech companies to develop and commercialize advanced therapies. These can be licensed back to other organizations in the Orgenesis network.

“We get market feedback that we want, say, a CAR-T for this indication,” Caplan explains. “If we find one, perhaps at an early stage, we put it into our network and, because it’s developed through a partnership, the cost is smaller.”

Final stage is process development

The final stage is process development and manufacturing through a distributed network of POC centers and mobile production units. According to Caplan, there are POC centers being set up in multiple countries, including the U.S. and China.

The POC centers are designed to serve multiple hospital sites within a few hours’ drive. They provide quality assurance and a team that develops a manufacturing process to fit inside a container-sized clean room—an Orgenesis Mobile Processing Unit and Lab (OMPUL).

“We don’t sell the OMPULs, this isn’t our business model,” Caplan explains. “We do the process development and OMPULization, which includes adapting the automation to fit into the mobile unit, and also quality control. Then, we take this nice little package and supply to the required sites.”

The OMPULs can be sited near the POC to reduce transport and storage issues. They are designed to be self-contained and for easy scale-out.

“It allows for quick expansion,” she explains. “You can start with one isolation unit and, if you want to increase capacity, you can bring in another OMPUL without changing GMP and QA.”