System for separating a cell sample by centrifugation and column chromatography while maintaining sterility

An apparatus configured for fractionating a cell sample, the apparatus comprising:

• (a) a sample processing unit that includes a first holder sized and shaped to reversibly secure a rotatable container, and a drive configured to rotate such a rotatable container when secured in the first holder, thereby applying centrifugal force to a blood or bone marrow sample in the container so as to separate different cell types in the sample according to a first cell characteristic;
• (b) a sample separation unit that includes a second holder sized and shaped to reversibly secure a cell separation column, the sample separation unit being configured to operate such a cell separation column secured in the second holder so as to separate different cell types according to a second cell characteristic;
• wherein the apparatus is configured to be operatively installed with a sterile tubing set that comprises:
• (i) a first connector configured for sterile connection of a sample container;
• (ii) a rotatable container that operatively fits in the sample processing unit;
• (iii) a first inlet port configured to deliver a first cell population into the rotatable container for separation;
• (iv) a first outlet port configured to receive a selected subset of cells from the first cell population that have been separated by the rotatable container;
• (v) a second inlet port configured to deliver a second cell population onto a cell separation column secured in the second holder;
• (vi) said cell separation column which operatively fits in the sample separation unit;
• (vii) a second outlet port configured to receive a subset of cells that has been selected from the second cell population by the cell separation column;
• and
• (viii) a second connector configured for sterile connection to a product collection container;
• so that when a cell sample is supplied into the tubing set through the first connector, the sample can be processed by the apparatus in the rotatable container secured in the first holder and processed by the apparatus in the cell separation column secured in the second holder, following which a product therefrom can be delivered by the apparatus though the second connector into a product collection container, whereby cells in the product have been kept sterile during processing in the sterile tubing set.