Device and procedure for producing a cellular pharmaceutical product enriched in genetically modified target cells at the bedside or in a surgical room

A device for preparing a cell population for therapy for a patient in need thereof,

• wherein the device comprises the following components:
• a sample processing unit that includes an input port operably connected to a sample chamber, wherein the sample chamber is configured to incubate or culture cells, and is also configured to centrifuge cells contained in the chamber,
• a sample separation unit that includes a separation column,
• fluid circuitry that interconnects the sample processing unit and the sample separation unit, so that a sample can flow between the sample processing unit and the sample separation unit in either direction;
• a pump, and
• a plurality of valves that are configured and positioned to control fluid flow through the fluid circuitry;
• wherein the components of the device are constructed and arranged so that a user of the device can prepare the cell population according to the following procedure:
• receiving a sample of cells through the input port into the sample chamber,
• centrifuging the sample in the sample chamber to separate and remove red cells,
• transferring the sample from the sample chamber to the sample separation unit,
• separating target cells from non-target cells using the separation column, allowing the non-target cells to pass to a waste container,
• transferring the separated target cells back to the sample chamber, and
• adjusting the cells in an infusion solution to produce a pharmaceutical product having a desired volume or cell concentration;
• wherein the components of the device are arranged in a closed system, thereby configuring the device to perform said procedure in a sterile environment whereby the pharmaceutical product produced from the device is suitable for cellular therapy of a patient in need thereof.