Patent ID: 11933787
Assignee: MILTENYI BIOTEC B.V. &CO.KG
Field: Pharmaceuticals (Chemistry)
Classification: CPC G  A  B  C | IPC A  B  C  G

Claim 0:
1. A closed automatic system for manufacturing a therapeutic cell population for administration to a patient in need thereof,
wherein the system comprises a single-use assembly that 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 volume of the sample 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 components of the assembly are constructed and arranged to receive a population of donor cells and to manufacture therefrom said therapeutic cell population by applying a process that comprises a plurality of steps selected from the following:
(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; and/or
(d) expansion of cells by culturing in fresh media before or after step (a);
and thereafter to wash and formulate the therapeutic cell population in an adjusted volume of injectable liquid;
wherein the system is closed and sterile, whereby said therapeutic cell population manufactured therewith is suitable for administration to a human patient;
wherein the single-use assembly is configured to be reversibly installed on a computer-controlled apparatus that operates the sample processing unit, the sample separation unit, and the fluid circuitry so as to manufacture the therapeutic cell population from the population of donor cells, after which the assembly maybe removed from the apparatus and replaced with another single-use assembly to process another population of donor cells.