Preparing genetically modified cells using a device that is configured for sterile processing of cells at the bedside or in a surgical room

An automated computer-controlled method performed on a device, wherein the method comprises:

• delivering a sample of cells through an input port into a sample chamber on the device,
• transferring the sample of cells from the sample chamber using a pump through at least one open value into a sample separation unit on the device,
• separating target from non-target cells from the sample in the sample separation unit, allowing the non-target cells to pass to a waste container,
• transferring the target cells using the pump through at least one open value back to the sample chamber,
• delivering to the target cells in the sample chamber a reagent that includes DNA, RNA, or virus, and cultivating or incubating the cells in a cell medium whereby genetically modified cells are produced,
• centrifuging the genetically modified cells and removing a volume of the cell culture medium, and
• resuspending the genetically modified cells in a volume of an infusion solution to produce a pharmaceutical product;
• wherein the aforelisted steps of the method are all performed by the device in a closed sterile system whereby the pharmaceutical product is suitable for cellular therapy of a patient in need thereof.

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

• wherein the device comprises the following components:
• a sample processing unit that includes an input port and an output 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 that is operably connected to the output port of the sample processing unit,
• fluid circuitry that interconnects the sample processing unit and the sample separation unit,
• a pump, and
• a plurality of valves that 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:
• delivering a sample of cells through the input port to the sample chamber,
• transferring the sample from the sample chamber through at least one open value using the pump into the sample separation unit,
• separating target from non-target cells using the separation column, allowing the non-target cells to pass to a waste container,
• transferring the target cells through at least one open value using the pump back to the sample chamber,
• delivering to the target cells in the sample chamber a reagent that includes DNA, RNA, or virus, and cultivating or incubating the cells in a cell medium whereby genetically modified cells are produced,
• centrifuging the genetically modified cells and removing a volume of the cell culture medium,
• resuspending the genetically modified cells in an infusion solution, and
• adjusting the cells in the infusion solution as needed to produce a pharmaceutical product having a desired volume or cell concentration for transfer to a final product container;
• wherein the components of the device are arranged in a closed system, thereby configuring the device to perform the aforelisted steps of the method in a sterile environment whereby the pharmaceutical product produced from the device is suitable for cellular therapy of a patient in need thereof.