Smart cell manufacturing for therapeutic applications
Cell therapy is emerging as a promising approach for many incurable and chronic diseases, such as cancer and diabetes. Cell therapy usually treats patients with their own cells or uses a universal cell source rather than chemical pharmaceuticals. To produce these cells, specialised infrastructure and highly skilled technicians are required, rendering the process laborious and expensive. Moreover, the pressing demand for large numbers of high quality cultured cells necessitates the development of autonomous cell culture systems that function at much lower costs.
An autonomous cell expansion platform
To address this challenge, the EU-funded Facer project proposes to bring to the market an autonomous cell culture platform. “Facer platform can autonomously manufacture billions of high-quality cells starting from a small biopsy of cells,” explains Miquel Costa, project coordinator, founder and CTO of Aglaris. The Facer platform works with single-use cartridges where the cells are expanded under continuous monitoring without human intervention, minimising contamination risks from cell handling. The closed system culture chamber has been designed to maintain homogeneous conditions, batch-to-batch consistency, and repeatability in cell production. Moreover, the platform is a modular system that can simultaneously produce cells from up to five different sources without cross contamination. “What makes Facer solution different from others in the market is its versatility, scalability and automation. By changing cartridges, it is possible to produce different cell types and therapies,” emphasises Costa. In addition to autonomous monitoring, advances in the bioreactor design alongside AI enable autonomous decision making for production optimisation. Importantly, the Facer bioreactor is easy to use, offering the capacity to produce cells at a single location, without depending on external companies.
Bioreactor optimisation for industrial use
Researchers have optimised the design of a Facer platform cartridge for the expansion of high-quality chimeric antigen receptor (CAR)-T cells at industrial scale. Cell yield after 10 days of culture was nearly double compared to conventional cell bioreactors. Ongoing activities will soon enable the production of mesenchymal stem cells for therapeutic and regenerative purposes as well as other adherent cells. Overall, the design process has been carefully aligned with end user needs. This is also true with regards to the software where a new user interface has been created to improve user experience and maximise functionality. The Facer platform provides a competitive advantage over other solutions in the market, while ongoing communication with key opinion leaders in the field will provide the necessary feedback for producing the commercial units. “It combines the robustness of good manufacturing practice equipment with the flexibility of a process development bioreactor, and we know that this is something that cell and gene therapy researchers have been waiting for,” continues Costa. It will expedite the screening and evaluation of therapeutics under development at a reduced cost, bringing novel treatments sooner for regulatory and clinical approval. Facer solution is also expected to assist the production of tailored treatments in hospitals and clinics. Cell manufacturers and contract manufacturing organisations can use the Facer platform to scale up standardised culturing processes.
Keywords
Facer, bioreactor, cell therapy, cell culture, CAR-T cells, gene therapy, mesenchymal stem cells
