Equipment and procedure for culturing, separating, and genetically modifying donor cells for reinfusion into a patient

A method for providing a cellular product enriched in target cells,

• wherein the method is performed in a single use tubing set that comprises:
• (1) a sample processing unit that includes an input port operably connected to a sample chamber, wherein the sample chamber comprises additional ports to supply fresh media and gasses to support culture of cells in the chamber;
• (2) a sample separation unit that includes a magnetic separation column, and
• (3) fluid circuitry that interconnects the sample processing unit and the sample separation unit so that cells can flow between the sample processing unit and the sample separation unit in either direction;
• wherein the method performed in the single use tubing set comprises:
• (a) installing the single use tubing set onto an apparatus that is configured to operate the sample processing unit, the sample separation unit, and the fluid circuitry;
• (b) receiving a sample of cells through the input port into the sample processing unit;
• (c) preparing the sample of cells in the sample processing unit;
• (d) transferring the prepared cells from the sample processing unit to the sample separation unit;
• (e) separate the prepared cells into target cells and non-target cells in the sample separation unit using the magnetic separation column, allowing non-target cells to pass to a waste container;
• (f) transferring the separated target cells back to the sample processing unit;
• (g) culturing the target cells with genetic material in the sample chamber, supplying gas and fresh media as needed for the culturing, thereby genetically modifying the cells;
• (h) processing the genetically modified cells by washing and adjusting volume;
• and thereafter
• (i) delivering the genetically modified cells as a cellular product to a product collection container;
• wherein the single use tubing set constitutes a closed sterile system, whereby the cellular product delivered to the product collection container in step (i) is suitable for administration to a human patient in need thereof.