GE Healthcare Launches Sefia Platform to Aid Cell Therapy Production

At the International Society for Cellular Therapy's Regional Meeting in Memphis, TN, GE Healthcare’s recently acquired Biosafe Group introduces Sefia, a state-of-the-art, multi-function platform which uses a combination of continuous-flow centrifugation, temperature control and fluidic management to enable purification, concentration, washing and final formulation during cell processing. Combined with GE Healthcare's existing portfolio, Sefia further advances access to a single-solution manufacturing platform to enable turnkey, scalable manufacturing of cell therapies.

Sefia is a functionally-closed laboratory instrument, CE certified for safety compliance with IEC 61010, IEC 61 326, and IEC 62304 standards, and designed for use in good automated manufacturing practice (GAMP)-compliant environments. Harnessing two new technologies - along with smart process control, temperature regulation and eight separate fluid pathways - Sefia performs simple and complex manipulation of large volumes of cells at a fast processing speed.

Sefia features the 'CT 800.1' kit, with the 'A-800' continuous flow separation chamber (allowing for processing of large volumes of cellular products at a flow rate up to 10 litres per hour). 'FlexCell', the first of several forthcoming protocols designed for specific cell therapy applications. The FlexCell protocol and kit will be dedicated to large-volume washing of cells in the production of CAR-T therapies.

The Sefia platform builds on Biosafe's experience in the cell therapy and regenerative medicine market with its Sepax™ and Smart-Max machines. Integrating Biosafe's products into GE's portfolio of tools, technologies, and services brings the industry closer to a complete ecosystem that supports the industrialization of this emerging class of medicine.

Sefia offers:

• The 'CT 800.1' kit, including the 'A-800' continuous flow separation chamber
• Versatile applications serving preparation, isolation, washing, concentration and final formulation steps of a cell therapy process
• Combinable protocols, temperature regulation and smart process control
• A closed and sensor controlled system
• Full process traceability with GMP compliance
• Flexibility of production with up to eight separate fluid pathways
• Intuitive user guidance