UNIT OPERATION / PRODUCTION PROCESS


Cell/Gene Allogeneic Therapy

Allogeneic Cell Therapy involves the transfer of cells from one person to another for therapeutic purposes. It is much more complicated compared to autologous cell therapy, as problems such as donor availability, rejections, and the need for immunosuppression come hand in hand with it. However, with scientific discoveries dedicated to solving these problems, allogeneic cell therapy is a much more promising therapy, as compared to autologous cell therapy, because of its sustainability. With the right platform and technological improvements, allogeneic cell therapy can be administered to billions of patients worldwide using cells from a couple of hundred donors only.

Cell proliferation through large scale production is recommended to cater numerous patients worldwide. Challenges in the manufacturing procedure involves the cGMP compliance. Therefore, necessary sterile conditions and equipment are needed each step to complete the process while adhering to cGMP. The manufacturing facility need to have a certified and well trained personnel, a controlled clean room, and equipment such as tide motion bioreactors and cell therapy aseptic isolators to be used in the proliferation procedure. This type of medical approach in cell therapy involves complex process since it need screening and testing of possible donors before bioprocessing.