Terumo Blood and Cell Technologies, a medical technology company specializing in technology, software and services for blood component collection, therapeutic apheresis and cellular technologies, released an advanced software 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 breakthrough 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 into how to embed Finia into pre-existing manufacturing and data processes.

The new software release includes 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 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. Finia manages variability risk by automatically completing each aspect of the formulation and fill and finish the process. The automation provided aims to help significantly reduces employee time during the fill and finish process compared to that of a manual process. The system maintains uniformity of cell concentrations to within 5 percent for all product bags and the quality control bag, according to the company, and the process maintains > 95 percent of pre-formulation viability and 90 percent post-thaw viability.

“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,” said Delara Motlagh, General Manager, Cell Therapy Technologies, Terumo Blood and Cell Technologies. “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.”