Cellular Origins and Fresenius Kabi collaborate on automated cell therapy manufacturing
Partnership focuses on Cue system integration
Partnership focuses on Cue system integration
In a significant development for the cell and gene therapy (CGT) manufacturing sector, Cambridge-based Cellular Origins has entered into a strategic partnership with global healthcare company Fresenius Kabi. The collaboration, announced on 16 October 2024, aims to integrate Fresenius Kabi’s cell therapy processing technologies with Cellular Origins’ Constellation robotic manufacturing platform.
The CGT sector has long struggled with manufacturing scalability issues, particularly regarding consistent production processes and personnel requirements. This collaboration specifically targets these challenges by focusing initially on the integration of Fresenius Kabi’s Cue Cell Processing System within the Constellation platform.
The integration strategy encompasses comprehensive automation of consumable transport, connection procedures, installation processes, and operational control. The partnership aims to establish a fully automated 24/7 manufacturing capability that optimises space utilisation while minimising staffing requirements – all without necessitating process modifications.
Technical integration specifications
The initial phase concentrates on the Cue System’s integration, selected for its specialised capabilities in automated small-volume cell processing. The system’s versatility in handling critical applications, including final formulation and culture media exchange, made it the primary candidate for integration with Constellation’s automation architecture.
Dr Edwin Stone, CEO at Cellular Origins, emphasised the strategic importance of the collaboration: “Forming strong collaborations is essential to ensuring the industry can implement the transformative power of automation whilst using the tools that are best for the biology and, therefore, for patients.”
Future development pathway
Following the Cue system integration, the collaboration’s scope is expected to expand to encompass Fresenius Kabi’s broader cell therapy technologies portfolio, including the Lovo Cell Processing System and developmental products in the pipeline.
Dr Christian Hauer, President MedTech at Fresenius Kabi, commented: “Our cell therapy technologies are designed with automation at their core, to provide new levels of precision and efficiency. By working closely with the team at Cellular Origins, we hope to advance the CGT industry by helping therapy developers embrace automation during the production process with the goal of ultimately benefitting patients.”
Regulatory considerations
It should be noted that while the Cue Cell Processing System is currently limited to laboratory use and cannot be employed for direct transfusion, the partnership’s developments could potentially influence future regulatory pathways for automated CGT manufacturing processes.
Dr Edwin Stone, CEO at Cellular Origins
