Single use tubing set for making genetically modified donor cells for reinfusion into a patient

A sterile single-use tubing set for preparing a cell population for therapy for a patient in need thereof,

• wherein the tubing set comprises the following components:
• (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 and is configured to wash target cells and/or adjust volume of the sample as needed;
• (2) a sample separation unit that includes a magnetic cell 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 components of the tubing set are constructed and arranged so that a user of the tubing set can prepare the cell population for human administration according to the following procedure:
• (a) receive a sample of cells through the input port into the sample processing unit of the tubing set;
• (b) prepare the sample of cells in the sample processing unit;
• (c) transfer the prepared cells from the sample processing unit to the sample separation unit,
• (d) 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,
• (e) transfer the separated target cells back to the sample processing unit;
• (f) combine and culture the target cells with genetic material in the sample chamber, supplying gas and fresh media as needed so as to genetically modify the cells;
• (g) process the genetically modified cells by washing and adjusting volume;
• and thereafter
• (h) deliver the genetically modified cells as a cellular product to a product collection container;
• wherein the single use tube set constitutes a closed sterile system, whereby the cellular product delivered to the product collection container is suitable for administration to a human patient in need thereof;
• wherein the single use tubing set is configured to be reversibly installed on an apparatus that operates the sample processing unit, the sample separation unit, and the fluid circuitry so as to process cells in the tubing set and deliver a cellular product to the product collection container, after which the tubing set is removed from the apparatus and replaced with another tubing set to process another sample of cells.