Terumo and Charles River Laboratories have released data highlighting the effectiveness of Terumo’s BCT Finia automated system in streamlining the cell and gene therapy (CGT) manufacturing process.
The Finia system is an automated machine that plays a crucial role in the “fill and finish” stage of manufacturing CGTs. This involves preparing, cooling, dividing, and packaging the final product into doses.
The system processes large volumes of therapeutic material, ensuring that the correct dose is packaged with minimal impact on the cell’s viability and functionality.
Data published in the Cytotherapy journal demonstrated that when Finia was integrated into a Charles River T cell workflow, it successfully processed a 304mL product in four consecutive runs, resulting in 16 product bags. This represents a four-fold increase in capacity within two hours.
The system produced accurate final volumes, maintained the health and functionality of the cells, and reduced the manual effort needed, which saves time and minimises the potential for human error. Additionally, Finia effectively controlled the temperature throughout the process, reducing the cells’ exposure to dimethyl sulfoxide (DMSO), a cytoprotectant used to preserve cells at low temperatures. This helps protect the cells from damage during processing.
Charles River’s director of process development Alex Sargent said: “We are excited by the prospect Finia’s automation offers to make CGTs more accessible by lowering costs while accelerating development and manufacturing.
“Through this collaboration, we’ve shown that an expert team can seamlessly integrate technological advances like Finia into existing workflows, leveraging its flexibility to improve manufacturing without impacting final product quality.”
CGTs are blockbuster treatments that offer the potential to cure or significantly alter the course of diseases, especially those that were previously considered untreatable. However, they come with a high price tag, partly due to the complexity of the manufacturing process.
Many companies have been looking at innovative ways to streamline the manufacturing process. In May 2024, Swiss start-up Limula raised $6.8m to advance its cell therapy manufacturing platform. The device comprises the functionalities of a bioreactor and a centrifuge into one single closed vessel, designed to cut costs over the traditional manufacture of stem cells.
