GE Healthcare’s Biosafe Introduces Sefia Platform
Product News Oct 01, 2016
At the International Society for Cellular Therapy’s Regional Meeting in Memphis, TN, GE Healthcare’s recently acquired Biosafe Group introduces Sefia 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.
• FlexCell protocol
• 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