CPC G16H 20/00 (2018.01) [A61K 35/13 (2013.01); C12N 5/0693 (2013.01); G06Q 10/0832 (2013.01); G16H 10/60 (2018.01); G16H 80/00 (2018.01)] | 31 Claims |
1. A method for coordinating manufacturing a cell therapy product by expanding a population of cells obtained from a tumor from a patient into the cell therapy product using a multi-step cell expansion process, the method comprising:
receiving, by a computing device, a cell order request to expand the population of cells for the patient;
generating, by the computing device, a cell order identifier including a patient-specific identifier associated with the cell order request;
performing, at a medical facility, a tumor resection procedure on the patient to obtain a portion of the tumor or a population of cells from the tumor from the patient, the tumor resection procedure comprising:
resecting the portion of the tumor or the population of cells from the tumor using a predetermined protocol,
logging, at the computing device, information associated with materials and processes used during each step of the predetermined protocol, and
transmitting the logged information associated with the tumor resection procedure to a manufacturing facility,
wherein the computing device is configured to: prevent entry of information associated with materials and processes used in a subsequent step unless certain criteria associated with a preceding step are met;
after receiving the portion of the tumor or the population of cells at the manufacturing facility, determining, by the computing device, a preliminary schedule for the multi-step cell expansion process and a preliminary schedule of patient treatment events;
initiating expansion of the cell therapy product from at least some of the portion of the tumor or the population of cells using the multi-step cell expansion process;
performing quality control assays to determine acceptance parameters for the expanded cell therapy product at a plurality of time points during the multi-step cell expansion process;
determining whether the acceptance parameters for the expanded cell therapy product meet acceptance criteria; and
in response to a determination that that the acceptance parameters meet the acceptance criteria, completing the multi-step cell expansion process in accordance with the preliminary schedule for the multi-step cell expansion process to obtain manufactured cell therapy product,
wherein the preliminary schedule of patient treatment events include one or more of an inpatient stay time period, resection date, lymphodepletion date, infusion date for infusing the patient with the manufactured cell therapy product and IL-2 treatment date.
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