US 12,230,379 B2
Systems and methods for coordinating manufacturing of cells for patient-specific immunotherapy
Anne Brooks, Downingtown, PA (US); Steve Macrides, West Chester, PA (US); and Kristin Lanzi, San Francisco, CA (US)
Assigned to Iovance Biotherapeutics, Inc., San Carlos, CA (US)
Filed by Iovance Biotherapeutics, Inc., San Carlos, CA (US)
Filed on Jun. 24, 2021, as Appl. No. 17/357,393.
Application 17/357,393 is a continuation of application No. 17/238,092, filed on Apr. 22, 2021.
Claims priority of provisional application 63/159,806, filed on Mar. 11, 2021.
Claims priority of provisional application 63/155,711, filed on Mar. 2, 2021.
Claims priority of provisional application 63/013,942, filed on Apr. 22, 2020.
Prior Publication US 2021/0407640 A1, Dec. 30, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. G16H 20/00 (2018.01); A61K 35/13 (2015.01); A61K 39/00 (2006.01); C12N 5/0783 (2010.01); C12N 5/09 (2010.01); G06Q 10/0832 (2023.01); G16H 10/60 (2018.01); G16H 80/00 (2018.01)
CPC G16H 20/00 (2018.01) [A61K 35/13 (2013.01); A61K 39/4611 (2023.05); A61K 39/4644 (2023.05); C12N 5/0638 (2013.01); C12N 5/0693 (2013.01); G06Q 10/0832 (2013.01); G16H 10/60 (2018.01); G16H 80/00 (2018.01)] 21 Claims
OG exemplary drawing
 
1. A method of manufacturing a cell therapy product for treating cancer in a patient, the method comprising:
receiving, at a computing device, a cell order request to manufacture the cell therapy product for the patient by processing at least a portion of a tumor or a population of cells obtained from the patient using a multi-step cell expansion process, manufacturing slots for performing the multi-step cell expansion process, and a preliminary schedule of patient treatment events for treating the patient with the cell therapy product, wherein the patient treatment events include infusing the cell therapy product into the patient;
determining and displaying in a scheduling user interface, by the computing device, one or more available manufacturing slots for performing the multi-step cell expansion process based on the preliminary schedule of patient treatment events;
after selection of one of the available manufacturing slots, performing, at a medical facility, a procedure on the patient to obtain the portion of tumor or the population of cells from the patient in accordance with the preliminary schedule of patient treatment events and the selected available manufacturing slot;
generating a container label including a patient-specific identifier and a cell order identifier to be associated with a shipping container containing the portion of tumor or the population of cells;
transferring the portion of tumor or the population of cells to a manufacturing facility corresponding to the selected available manufacturing slot, reading the container label and transmitting a first message indicating a change of custody of biological material comprising the portion of the tumor or the population of cells;
performing a quality check procedure on the tumor or the population of cells and upon determining that the portion of the tumor or the population of cells meets a predetermined quality criteria, generating a manufacturing label, including the patient-specific identifier and the cell order identifier, to be associated with a manufacturing container used in the multi-step cell expansion process; and
initiating, at the manufacturing facility, the multi-step cell expansion process, and transmitting a second message indicating a second change of custody of the biological material based on reading of the manufacturing label,
wherein the manufacturing slots are indicative of availability of equipment and personnel at the manufacturing facility to enable the manufacturing facility to manufacture the cell therapy product.