Terumo BCT and its pharmaceutical partners recognized a need to bring more control and consistency to the process of filling and finishing dispensing containers for cell therapy developers and researchers. The manual procedure after final formulation involves aliquoting, cooling, mixing, filling and sealing single-use, sterile bags for subsequent patient infusion. The process is tedious, time consuming, subject to variability and requires diligent aseptic technique to maintain sterility. Terumo BCT envisioned a system to automate the process.
On time and on budget:
Design engineering for the hardware portions of the project to meet aggressive schedule requirements
As Terumo BCT indicates on their website, “Finally, Finia. The wait for downstream fill/finish automation is over.”
Finia successfully combines and controls the processes to fill and finish cell therapy formulation, for each specific patient. This includes mixing, maintaining product viability, reducing variability, allowing custom fill volumes and sealing the sterile dispensing bags, while assuring consistent cool temperatures throughout the process. Learn more about Finia.
Initial engineering of all aspects of the project
Prototypes for feasibility studies
Production level design
Human interface design
VHF ultrasound design
Infrared eye tracker design
Design history files (DHF)
Device master record (DMR)
ERI manufactures Finia hardware in Golden, Colorado