SYSTEM AND METHOD FOR PROCESSING, INCUBATING, AND/OR SELECTING BIOLOGICAL CELLS
First Claim
1. A system for automated processing of a cell product comprising surface antigen expressing cells, in preparation for surface antigen expressing cell selection, the system comprising:
- a reusable separation apparatus controlled by a microprocessing controller unit driven by software, wherein the apparatus and microprocessing controller unit are configurable with a plurality of settings;
a disposable sterile circuit configured to associate with the reusable separation apparatus, the disposable sterile circuit comprising a spinning membrane separator comprising a porous membrane, wherein the separator comprises an inlet and first and second outlets;
a cell product in communication with the inlet of the separator, wherein the separation apparatus is configured in a first cycle by the microprocessing controller to flow the cell product into the inlet of the separator, separate platelets and supernatant from the first outlet into a filtrate container, and separate remaining cellular components from the second outlet into an in-process container;
wash media within a media container in communication with the in-process container, wherein the separator is configured by the separation apparatus in a second cycle to flow the wash media into the in-process container containing the remaining cellular components to form resuspended platelet-depleted cell product;
a port located on the in-process container configured to receive an agent having an association with the surface antigen expressing cells of the resuspended platelet-depleted cell product, wherein the in-process container is configured to incubate the agent with the surface antigen expressing cells over an incubation period sufficient for the agent to bind and/or associate with the surface antigen expressing cells to form a first mixture, comprising antigen-agent complexes, unbound/unassociated agent, and cells not presenting the antigen;
wherein the separation apparatus is configured in a third cycle to separate the first mixture into unbound/unassociated agent, directed from the first outlet into the filtrate container, and a second mixture, comprising antigen-agent complexes and cells not expressing the antigen, directed from the second outlet to a retentate container, wherein the second mixture is ready for target cell selection.
1 Assignment
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Accused Products
Abstract
A method for automated processing of a cellular product comprising target substrate cells, the method comprising providing a separation apparatus configured to associate with a disposable sterile circuit comprising a separator in communication with the cellular product. The apparatus and disposable sterile circuit are configured to remove platelets from the cellular product to form a platelet-depleted cellular product, resuspend the platelet-depleted cellular product in media to form a resuspended platelet-depleted cellular product, receive an agent having an association with the target substrate cells of the resuspended platelet-depleted cellular product, incubate the agent with the target substrate cells over a period sufficient for the agent to bind with and/or enter the target substrate cells to form a first mixture comprising agent-target substrate cell complexes, unbound/unassociated agent, and non-target substrate cells, and remove unbound/unassociated agent to form a second mixture comprising the agent-target substrate cell complexes and non-target substrate cells.
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Citations
20 Claims
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1. A system for automated processing of a cell product comprising surface antigen expressing cells, in preparation for surface antigen expressing cell selection, the system comprising:
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a reusable separation apparatus controlled by a microprocessing controller unit driven by software, wherein the apparatus and microprocessing controller unit are configurable with a plurality of settings; a disposable sterile circuit configured to associate with the reusable separation apparatus, the disposable sterile circuit comprising a spinning membrane separator comprising a porous membrane, wherein the separator comprises an inlet and first and second outlets; a cell product in communication with the inlet of the separator, wherein the separation apparatus is configured in a first cycle by the microprocessing controller to flow the cell product into the inlet of the separator, separate platelets and supernatant from the first outlet into a filtrate container, and separate remaining cellular components from the second outlet into an in-process container; wash media within a media container in communication with the in-process container, wherein the separator is configured by the separation apparatus in a second cycle to flow the wash media into the in-process container containing the remaining cellular components to form resuspended platelet-depleted cell product; a port located on the in-process container configured to receive an agent having an association with the surface antigen expressing cells of the resuspended platelet-depleted cell product, wherein the in-process container is configured to incubate the agent with the surface antigen expressing cells over an incubation period sufficient for the agent to bind and/or associate with the surface antigen expressing cells to form a first mixture, comprising antigen-agent complexes, unbound/unassociated agent, and cells not presenting the antigen; wherein the separation apparatus is configured in a third cycle to separate the first mixture into unbound/unassociated agent, directed from the first outlet into the filtrate container, and a second mixture, comprising antigen-agent complexes and cells not expressing the antigen, directed from the second outlet to a retentate container, wherein the second mixture is ready for target cell selection. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. A method for automated processing of a leukapheresis product comprising surface antigen expressing cells, in preparation for surface antigen expressing cell selection, the method comprising:
providing a reusable separation apparatus controlled by a microprocessing unit driven by software, said apparatus configurable with a plurality of settings and configured to associate with a disposable sterile circuit comprising a separator comprising a porous membrane and in communication with the leukapheresis product, wherein the apparatus and disposable sterile circuit are configured to; remove platelets from the leukapheresis product in a first cycle to form a platelet-depleted leukapheresis product; resuspend the platelet-depleted leukapheresis product in media in a second cycle to form a resuspended platelet-depleted leukapheresis product; receive an agent having an association with the surface antigen expressing cells of the resuspended platelet-depleted leukapheresis product; incubate the agent with the surface antigen expressing cells over an incubation period sufficient for the agent to bind/associate with the surface antigen expressing cells to form a first mixture comprising antigen-agent complexes, unbound/unassociated agent, and cells not presenting the antigen; and remove unbound/unassociated agent in a third cycle to form a second mixture ready for target cell selection, wherein the second mixture comprises the antigen-agent complexes and cells not presenting the antigen. - View Dependent Claims (10, 11, 12, 13, 14, 15, 16, 17, 18)
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19. A method for automated processing of a cellular product comprising target substrate cells, in preparation for target cell selection, the method comprising:
providing a reusable separation apparatus controlled by a microprocessing unit driven by software, said apparatus configurable with a plurality of settings and configured to associate with a disposable sterile circuit comprising a separator comprising a porous membrane and in communication with the cellular product, wherein the apparatus and disposable sterile circuit are configured to; remove platelets from the cellular product in a first cycle to form a platelet-depleted cellular product; resuspend the platelet-depleted cellular product in media in a second cycle to form a resuspended platelet-depleted cellular product; receive an agent having an association with the target substrate cells of the resuspended platelet-depleted cellular product; incubate the agent with the target substrate cells over an incubation period sufficient for the agent to bind with and/or enter the target substrate cells to form a first mixture comprising agent-target substrate cell complexes, unbound/unassociated agent, and non-target substrate cells; and remove unbound/unassociated agent in a third cycle to form a second mixture ready for target cell selection, wherein the second mixture comprises the agent-target substrate cell complexes and non-target substrate cells. - View Dependent Claims (20)
Specification