Researchers from Osaka University report say they have developed an automated modular system for aseptic stem cell manufacturing. Masahiro Kino-oka, PhD, professor of biotechnology and director of the research base for cell manufacturability, is now working with industry partners to test and commercialize the platform.
According to Kino-oka, the modular platform has been manufactured by machine company Shibuya and is due to be tested in clinical trials by two biotechnology companies. Kino-oka, an ISO TC198 /WG9 expert as well, is also preparing regulatory standards for the use of the new technology as a collaborator of Japan’s Pharmaceutical and Medical Devices Agency.
“Our system is aims to improve cell manufacturability and, although developing the new machines is necessary, we also need new regulations as well as training and education,” he says.
The technology was developed by a consortium of companies—the Kotozukuri Consortium for Cell Manufacturability—whose aim is to make cell-based products simpler, safer, and efficient to manufacture, and to ensure they’re of consistent quality.
The system consists of a series of automated units, such as an incubator module, that allow for aseptic cell handling. The modules can be connected and disconnected via standardized transfer ports, with the goal of reducing processing times, and allowing for parallel operations.
The automated systems within each aseptic closed unit are designed to take advantage of computer modeling. According to Kino-oka, the system can be used to carry out multiple operations for manufacturing retinal pigment epithelial (RPE) cells, including defrosting and seeding, filtration, and dispensing.
Addressing the issue of maintaining an aseptic environment in the closed units, he says, “After we finish a process, we need to clean for the changeover. There’s no regulations for how to do this right now so, for practical production we need to risk manage.
“We have academic papers about clean up. We check how droplets are distributed on the floor and how they move during the aseptic processing, and we regulate the number and direction of the droplets. We also use a decontamination system with a reagent,” he explains, adding that the team hopes to reduce the four-hour clean-up time.
Kino-oka presented on the technology at TERMIS in November 2021.