LAKEWOOD, COLO., U.S.A. - 14 September 2021 -Terumo Blood and Cell Technologies (Terumo), a medical technology company specializing in a portfolio of technology, software and services for blood component collection, therapeutic apheresis and cellular technologies, is announcing an advanced software release for its Finia Fill and Finish System. The update is in response to customer feedback, bespoke requirements and customer insights into a rapidly evolving manufacturing process, as well as regulatory adaptation to a market for increasingly automated technology.
As the cell and gene industry continues to expand and a growing number of therapies break through to the commercial stage, the demand for automation has continued to rise. Finia is a functionally closed, automated system. During the regulatory process, automation can help increase the likelihood that drugs can gain approval. Since the initial launch of Finia, Terumo has engaged with customers to understand their processes, needs and pain points and to adapt quickly to an ever-changing and advancing market. This has provided Terumo with important insights in to how to embed Finia into pre-existing manufacturing and data processes. Furthermore, bespoke requirements from some of Terumo's larger pharmaceutical customers have also contributed to the product updates.
The new software release will bring several new features and enhancements to the Finia Fill and Finish System, including automated procedure configuration and enhanced reporting. The update also includes offline mode, enabling the Finia system to run without network connectivity, and removes the risk of delay due to IT complications. The Cell Processing Application (CPA) can manage multiple Finia devices from a central server, supporting cGMP compliance with user authentication, electronic batch reporting and workflow configuration.
The first of its kind, the Finia Fill and Finish system was released in 2019, bringing automation to the final step of cell therapy manufacturing. Finia can be used to process suspension and adherent cells. At such a crucial stage in the process, Finia manages variability risk by automatically completing each aspect of the formulation and fill and finish process. Finia also produces accurate and reproducible results. Automation provided by Finia helps significantly reduces employee time during the fill and finish process compared to that of a manual process.1,2 The system maintains uniformity of cell concentrations to within 5% for all product bags and the quality control bag.1 The process maintains > 95% of pre-formulation viability and 90% post-thaw viability.1
"The production and delivery of cell-based therapies is an evolving, complex and logistically challenging process, underscoring the importance of seeking industry feedback to understand the pain points and then adapt quickly. With Finia, we are expanding our portfolio of automated solutions to support this rapidly evolving industry. We are bringing innovations for cell and gene therapies to reduce manufacturing risks, provide scalability and enable commercialization of these life-saving therapies to meet the growing number of patients globally."
- Delara Motlagh, General Manager, Cell Therapy Technologies, Terumo Blood and Cell Technologies.
Data on file at Terumo Blood and Cell Technologies.
Cunningham A, Miller M, Sethi D. Formulation, fill, and finish using an automated closed system. Poster presented at CAR-TCR Summit; August 30-September 2, 2021; Digital.
About Terumo Blood and Cell Technologies
Terumo Blood and Cell Technologies is a medical technology company. Our products, software and services enable customers to collect and prepare blood and cells to help treat challenging diseases and conditions. Our employees around the world believe in the potential of blood and cells to do even more for patients than they do today.
Terumo Blood and Cell Technologies' customers include blood centers, hospitals, therapeutic apheresis clinics, cell collection and processing organizations, researchers and private medical practices. Our customers are based in over 130 countries across the globe. We have 750+ granted patents, with more than 150 additionally pending.
We have global headquarters in Lakewood, Colo., U.S.A., along with five regional headquarters, six manufacturing sites and six innovation and development centers across the globe. Terumo Blood and Cell Technologies is a subsidiary of Terumo Corporation (TSE: 4543), a global leader in medical technology. TERUMOBCT.COM
Terumo (TSE: 4543) is a global leader in medical technology and has been committed to “Contributing to Society through Healthcare” for 100 years. Based in Tokyo and operating globally, Terumo employs more than 30,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large.