The system, known as Finia, is fully automated, modular, and is a functionally closed system that allows the creation of user-defined doses for patients.
The end product is produced under temperature-controlled conditions, with air being removed from the product bags prior to sealing.
Finia’s processes meet current good manufacturing practices (cGMP), allowing users to record data through the fill-finish process and track access with user authentication.
According to the company, the technology removes the current ‘labor-intensive’ manner of manually performing fill and finish processes, which reduces the ‘risk of error’.
Delara Motlagh, VP of cell therapy technologies at Terumo, explained in detail how manual processes can introduce risk and thereby how automation offers a solution to these:
With any manual process, you have the following primary issues that contribute to final product variability or potential quality issues:
Contamination risk: While the production process is generally run in a clean-room, there are numerous open events that amplify the risk greatly. The Finia system is functionally-closed and eliminates open events as solutions are sterile docked, which significantly reduces contamination risks.
Inter- and intra-operator variability: Finia allows users to control the mixing process to ensure greater consistency in the final product, [as there can be] differing experience levels between operators and different performance levels based on day/time for any single operator.
Process control data deficiency: The lack of, or inefficiency of, obtaining data during the process, i.e. temperature, volume, etc. makes it difficult to control a process for and achieve consistent results.
In terms of its potential advantages over manual processes, Motlagh added that the Finia system minimizes the exposure of freezing in the fill and finish step of the cell manufacturing, which can adversely impact cells.
In addition, an operator using Finia can manage multiple processes at the same time, making the system more efficient, Motlagh concluded.