摘要 |
A closed system suitable for the aseptic culturing therapeutic cells comprises a vessel comprising: a gas permeable portion suitable for supporting cell growth and allowing delivery of gases to the cells during culturing, a vent comprising a conduit having an exterior orifice and an interior orifice spaced apart therefrom, the vent extending from the exterior of the system into the internal volume of the vessel and terminating therein with the interior orifice, wherein the interior orifice is arranged such that during filling and emptying of liquid medium it is not susceptible to blockage by liquid, the exterior orifice is adapted to connect to an aseptic filter thereby allowing passage of gases through the filter into the vessel or out of the vessel, as required to achieve the entry and exit of fluids and cells into the vessel, a port or ports adapted to allow introduction of fluids and cells aseptically into the vessel, and a port or ports adapted to allow fluids to exit the system without exposing the system to the external environment and adapted such that cells grown therein may exit the system under gravity when the system is orientated to put the cells in fluid communication with the exit port and the latter is opened. The present system facilitates the aseptic manufacturing of cells for use in therapy, without the need for a clean-room environment because no open processing steps are required. |