CEFObio Co., Ltd. is aiming to obtain the product approval for Off-the-shelf drugs and cell therapy agents with the proven clear mechanisms of action.
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Allogeneic cell therapyagent with prediction/quality control possible
· This is a cell therapy agent as a drug, not a procedure.
· Becausethe quality control (QC) is completed and stored in the frozen state, the Off-the-shelf drug can be realized.
· Since the allogeneic (other people's) cells are used rather than the autologous cells (the patient's own), the donor selection is possible, and the high-quality raw material can be secured.
· Umbilical cord, the cleanest tissue in the human body, is used, and we have the confirmation indicators that enable the purity control.
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High yield rate/economical production
· It is possible to operate the MCB (Master Cell Bank) in compliance with the advanced regenerative medicine and the biopharmaceutical laws.
· Our product has a superior yield rate compared to the other mesenchymal stem cells. Also, the cell banks can use the cells from Passage 1 and thefinished medical products can do the cells of early passages.
· By securing the economic feasibility through the mass production, we are overcoming the limitations of first-generation cell therapy agents that have been released so far.
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GMP of our own
· We produce thetherapeutic agents in our own GMP facility, which has received the manufacturing license for the advanced biopharmaceuticals.
· In the GMP production processes based on R&D know-hows, the culture media and enzymes developed by our own technology are used.
· This therapeutic agent is the ready-made allogeneic cell therapy agent and is produced in advance and cryopreserved, so it is not limited by theCapacity.
