US 11,713,442 B2
System and method for cell and tissue preparation
Richard E. Andrews, Manchester, NH (US); Stephanie M. Miskell, Weare, NH (US); Zachary T. Kops, Watertown, MA (US); Justin M. Ferrentino, Mont Vernon, NH (US); Michael C. Tilley, Amherst, NH (US); Andrew K. Capulli, Auburn, NH (US); Keira L McGrath, Manchester, NH (US); and Stuart A. Jacobson, Lexington, MA (US)
Assigned to DEKA PRODUCTS LIMITED PARTNERSHIP, Manchester, NH (US)
Filed by DEKA Products Limited Partnership, Manchester, NH (US)
Filed on Jun. 17, 2020, as Appl. No. 16/904,198.
Claims priority of provisional application 62/862,379, filed on Jun. 17, 2019.
Prior Publication US 2020/0392450 A1, Dec. 17, 2020
Int. Cl. C12M 1/36 (2006.01); B01L 3/00 (2006.01); B01L 9/06 (2006.01); C12M 3/06 (2006.01); C12M 1/00 (2006.01); C12M 1/26 (2006.01); C12M 1/12 (2006.01); C12M 1/02 (2006.01); C12M 1/34 (2006.01); G01N 35/00 (2006.01); G01N 35/10 (2006.01)
CPC C12M 41/48 (2013.01) [B01L 3/50273 (2013.01); B01L 9/06 (2013.01); C12M 23/16 (2013.01); C12M 29/00 (2013.01); C12M 33/10 (2013.01); C12M 37/00 (2013.01); C12M 41/18 (2013.01); C12M 41/36 (2013.01); C12M 41/44 (2013.01); C12M 45/20 (2013.01); G01N 35/00732 (2013.01); G01N 35/1004 (2013.01); G01N 35/1079 (2013.01); B01L 2300/021 (2013.01); B01L 2300/041 (2013.01); B01L 2300/0609 (2013.01); B01L 2300/1805 (2013.01); B01L 2400/0475 (2013.01); B01L 2400/06 (2013.01)] 18 Claims
OG exemplary drawing
 
1. A system for enabling automatic manufacture of tissue comprising:
a thaw subsystem including a thaw station receiving frozen cells in at least one vial and automatically thawing the frozen cells;
a thaw controller controlling the preparing of the cells;
an insulated container and container lid station having a cooling means cooling an environment surrounding the frozen cells in the at least one vial maintaining the frozen cells at a pre-selected temperature range;
a lid gripper and a vial gripper, the lid gripper moving, under control of the thaw controller, the container lid, the vial gripper moving, under control of the thaw controller, the at least one vial;
at least one device locating, under control of the thaw controller, a position of each of the at least one vial;
a decontamination station receiving, from the vial gripper, under control of the thaw controller, the at least one vial of thawed cells, the decontamination station including a means for decontaminating an exterior surface of the at least one vial of thawed cells, thereby forming at least one decontaminated vial of thawed cells;
a puncture station receiving, from the vial gripper, under control of the thaw controller, the at least one decontaminated vial of thawed cells, the puncture station including at least two needles, the at least two needles puncturing, under control of the thaw controller, the at least one decontaminated vial, a first needle of the at least two needles having a first length, a second needle of the at least two needles having a second length, the puncture station including a needle controller puncturing, under control of the thaw controller, the at least one decontaminated vial of thawed cells with the first needle, the first needle extending into the at least one decontaminated vial of thawed cells a first pre-selected distance, the needle controller puncturing, under control of a thaw manager, the at least one decontaminated vial of thawed cells with the second needle, the second needle extending into the at least one decontaminated vial of thawed cells a second pre-selected distance; and
a solution pump pumping, under control of the thaw controller, solution from a solution reservoir through solution tubing and the first needle into the at least one decontaminated vial of thawed cells, the thawed cells being drawn through the second needle, the thawed cells flowing through cell tubing into a cell reservoir, the cells being removed from the at least one decontaminated vial of thawed cells creating at least one waste vial,
wherein the thaw station is configured to receive, from the vial gripper, under control of the thaw controller, the at least one located vial, the thaw station including a thawing device housing the at least one located vial, the thawing device thawing the cells within the at least one vial, the thaw station including a thaw station controller, under control of the thaw controller, the thaw station controller providing a status of the cells to the thaw controller;
an expansion subsystem automatically pumping cells from at least one vial to at least one first bioreactor, the expansion subsystem automatically shutting valves from the at least one vial to the at least one first bioreactor when the cells are moved to the at least one first bioreactor, the expansion subsystem automatically creating a first pre-selected environment promoting expansion of the cells in the at least one first bioreactor, the expansion subsystem automatically pumping the expanded cells from the at least one first bioreactor to a concentrator when the expanded cells have reached a pre-selected density, the expansion subsystem configured to create resuspended cells from concentrated cells;
a concentration subsystem automatically concentrating the expanded cells; and
a maturation subsystem automatically pumping the resuspended cells into at least one second bioreactor when a pre-selected event has occurred, the maturation subsystem automatically creating a second pre-selected environment promoting maturation of the concentrated cells in the at least one second bioreactor based on monitoring sensor data of critical process parameters.