Method for manufacturing a patient specific cell population using a multifunctional self-contained apparatus and tubing set

A method of preparing a therapeutic cell population from a population of donor cells for administration to a patient in need thereof, the method comprising:

• reversibly installing a single-use assembly on a computer controlled apparatus;
• wherein the single-use assembly is closed and sterile, and is thereby configured to prepare said therapeutic cell population from a donor cell population in a manner such that the therapeutic cell population is suitable for administration to a human patient;
• wherein the single-use assembly includes the following components:
• (1) a sample processing unit that includes an input port operably connected to a sample chamber, wherein the sample chamber comprises ports to supply fresh media and gasses to support culture of a sample of cells in the chamber, and is configured to wash target cells and/or adjust sample volume as needed,
• (2) a sample separation unit that includes a magnetic separation member, and
• (3) fluid circuitry that interconnects the sample processing unit and the sample separation unit, so that cells can be caused to flow between the sample processing unit and the sample separation unit in either direction;
• wherein the computer controlled apparatus is configured to operate the sample processing unit, the sample separation unit, and the fluid circuitry of the single-use assembly in a sequence of steps chosen by an operator;
• programming or operating the computer-controlled apparatus to process a population of donor cells in the single-use assembly to produce the therapeutic cell population by applying a plurality of steps selected from the following steps (a) to (e):
• (a) positive or negative selection of a defined population of target cells using the magnetic separation member;
• (b) activation or differentiation of cells by culturing with one or more cytokines or growth factors;
• (c) transduction or transfection of cells by culturing with genetic material;
• (d) expansion of cells before or after any of steps (a) to (c) by culturing in fresh media;
• and
• (e) formulation of the therapeutic cell population in an adjusted volume of fresh liquid.