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.
• 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.
About GE Healthcare
GE Healthcare (gehealthcare.com) provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients.
About GE Healthcare Life Sciences
GE Healthcare's $4B Life Sciences business is on a mission to accelerate an age of molecular and precision medicine by providing expertise, tools and solutions for a wide range of applications, including basic research of cells and proteins, drug discovery, cell therapy and regenerative medicine, as well as tools and technology to support large-scale manufacturing of biopharmaceuticals, vaccines and biologics such as insulin. It also supplies leading contrast, PET and nuclear medicine agents for diagnostic imaging to help doctors make more informed diagnoses for better patient outcomes. The company's mission is to help enable a new era of molecular and precision medicine by providing customers with the tools, insight and knowledge to guide them ever more quickly from better biological understanding to better clinical therapies.
GE Healthcare Life Sciences acquired the Biosafe Group in July 2016. Biosafe (biosafe.ch) is active in the design, manufacture and marketing of automated cell processing systems.