FINIA® Fill and Finish System: A New Automation Solution for the Production and Delivery of Cell and Gene Therapy
October 2, 2019
LAKEWOOD, Colo. USA - October 2, 2019 - Terumo BCT's latest cell therapy technology, the Finia Fill and Finish System, is a first-of-its-kind device developed to help bring reproducibility and control to cell therapy manufacturing to get therapies to more patients who need them.
Finia is a fully automated, modular, functionally closed system that creates the final formulation of cell and gene therapies and divides them into user-defined doses for patients. The technology automates a process that is currently manual and labor-intensive with the added risk of error.
"Terumo BCT technologies have been automating the collection and processing of blood and cells for decades," said Antoinette Gawin, President and Chief Executive Officer, Terumo BCT. "Now, we're translating this knowledge to support technology breakthroughs in cell and gene therapies. Finia helps cell therapy developers and researchers simplify processes while increasing accuracy, consistency, reliability and reproducibility -- key to securing regulatory approval."
The Power of Automation
"The production and delivery of cell-based therapies is a complex and logistically challenging process," said Delara Motlagh, Vice President, Cell Therapy Technologies, Terumo BCT. "Developers and manufacturers appreciate support in determining when to automate, which processes to automate and how to integrate automation into their existing process."
Finia combines, mixes and divides the final product into predetermined volumes, all under controlled, refrigerated temperature. It automatically removes air before it seals the final product bags, simplifying the downstream process. Finia also works with Terumo BCT's Cell Processing Application software in the customers' network to facilitate compliance to current good manufacturing practices (cGMP), including electronic recordkeeping, control of process workflow, user credentialing and permission, and guidance of operators through the process with an intuitive user interface module (UIM).
"With Finia, we are expanding our portfolio of automation technologies aimed at this growing industry," said Motlagh. "We are bringing multiphase solutions for cell and gene therapies helping to scale manufacturing and drive toward commercialization to reach larger patient numbers."
About Terumo BCT
Terumo BCT is a global leader in blood component, therapeutic apheresis and cell therapy technologies. We believe in the potential of blood and cells to do even more for patients than they do today. Terumo BCT's Cell Therapy Technologies business enables researchers, developers and manufacturers to create next-generation cell and gene therapies. We do this through flexible, automated solutions that help meet evolving needs for reproducibility, quality and scale through the phases of development, from translational research to current good manufacturing practices (cGMP) for commercial manufacturing. www.terumobct.com