Systems and methods for coordinating manufacturing of cells for patient-specific immunotherapy
A method for coordinating the manufacturing of an expanded cell therapy product for a patient may include receiving a cell order request to expand the cell therapy product for the patient; generating a patient-specific identifier or cell order identifier associated with the cell order request; and initiating a process to expand the cell therapy product from at least some of a solid tumor obtained from the patient. If acceptance parameters for the expansion cell therapy product do not meet certain acceptance criteria at a second time point subsequent to a first time point in the expansion process, it is determined whether re-performing the expansion of the cell therapy product using the cell expansion technique is possible from the first time point based on the acceptance parameters at the second time point. If such re-performing the expansion is possible, patient treatment events that use the expanded cell therapy product are rescheduled.
1. A system for coordinating manufacturing of a cell therapy product for treating cancer in a patient, the system comprising:
at least one computing device and configured to:
receive and transmit patient information and a cell order request for manufacturing, using a multi-step cell expansion process, the cell therapy product from a population of cells obtained from a tumor resected from the patient, the patient information including a patient-specific identifier, and the cell order request including a cell order identifier, and
determine a schedule for patient treatment events including infusion of the cell therapy product in the patient based on an estimated completion date for obtaining of the cell therapy product manufactured by and received from a manufacturing facility using the multi-step cell expansion process;
generate a container label for a manufacturing container to be used in the multi-step cell expansion process for manufacturing the cell therapy product from at least a portion of the population of cells using a cell expansion technique, the container label comprising information associated with: (a) the cell order request including the cell order identifier, (b) the patient including the patient-specific identifier, and (c) the manufacturing facility where the cell therapy product is to be manufactured using the multi-step cell expansion process, wherein the multi-step cell expansion process comprises:
(i) initiating the multi-step cell expansion process for manufacturing the cell therapy product, and
(ii) initiating quality control assays to determine acceptance parameters at each of a plurality of time points during the multi-step cell expansion process,
receive the acceptance parameters obtained at the plurality of time points during the multi-step cell expansion process;
read the container label at each subsequent time point;
verify a chain of custody and a chain of identity based on the cell order identifier and the patient-specific identifier on the container label at corresponding subsequent time points;
generate a warning signal if:
the patient-specific identifier on the container label for a subsequent manufacturing step does not match the patient-specific identifier on the container label for an immediately preceding manufacturing step; and
determine appropriate further processing steps of the multi-step cell expansion process based on information read from the container label for completing the manufacturing of the cell therapy product.
2. The system of claim 1 , wherein the manufacturing subsystem is further configured to:
determine a preliminary schedule of manufacturing including a set of dates corresponding to the plurality of time points, including a first time point and a second time point subsequent to the first time point, for determining whether the acceptance parameters meet acceptance criteria at the corresponding time point during the multi-step cell expansion process depending on a cell expansion technique being used and when the cell order request is received at the manufacturing facility; and
determine a shipping schedule for shipping the cell therapy product based on the preliminary schedule of manufacturing.
3. The system of claim 1 , further comprising a logistics subsystem comprising at least one computing device and configured to:
transmit a shipping request to a logistics facility based on a shipping schedule received from the hospital-side subsystem and/or the manufacturing subsystem, and
verify the chain of custody and the chain of identity based on the cell order identifier and the patient-specific identifier.
4. A method for manufacturing a cell therapy product for treating cancer in a patient, the method comprising:
receiving, at a manufacturing facility, a population of cells from a tumor resected from the patient based on a cell order request;
generating, by a computing device, a container label for a manufacturing container to be used in a multi-step cell expansion process used for manufacturing the cell therapy product from at least a portion of the population of tumor cells, the container label comprising information associated with: (a) the cell order request including a cell order identifier, (b) the patient including a patient-specific identifier, and (c) the manufacturing facility wherein the cell therapy product is to be manufactured, wherein the cell order identifier and the patient-specific identifier define a chain of custody and a chain of identity for the cell therapy product;
initiating, at the manufacturing facility, the multi-step cell expansion process;
performing, at the manufacturing facility, a quality control assay to determine acceptance parameters at a plurality of time points during the multi-step cell expansion process;
receiving, at the computing device, the acceptance parameters at each of the plurality of time points;
reading, by the computing device, the container label at each subsequent time point;
providing, by the computing device, a warning signal if:
information relating to the patient on the container label for a subsequent manufacturing step does not match the information relating to the patient on the container label for an immediately preceding manufacturing step; and
determining appropriate further processing steps of the multi-step cell expansion process based on information read from the container label for completing the manufacturing of the cell therapy product.
5. The method of claim 4 , further comprising:
after receiving the population of the cells at the manufacturing facility, scheduling, by the computing device, patient treatment events including infusion of the cell therapy product in the patient, the scheduling being dependent on the acceptance parameters for subsequently obtained cell therapy product, and
determining the acceptance parameters for the cell therapy product at a plurality of time points during the multi-step cell expansion process.
6. The method of claim 4 , further comprising determining a preliminary schedule of manufacturing including a set of dates corresponding to the plurality of time points, including a first time point and a second time point subsequent to the first time point, for determining whether the acceptance parameters at a given of the plurality of time points meet acceptance criteria at the given time point depending on the cell expansion technique being used and when the cell order request is received at the manufacturing facility.
7. The method of claim 6 , further comprising receiving courier status information via a logistics subsystem,
in response to receiving the preliminary schedule, determining a shipping schedule for shipping the cell therapy product based on the preliminary schedule of manufacturing; and
generating a shipping label for a shipping container containing the cell therapy product.
8. The method of claim 7 , further comprising transmitting a shipping request to a logistics facility based on the determined shipping schedule.
9. The method of claim 6 , wherein determining whether the acceptance parameters meet acceptance criteria comprises determining the acceptance parameters at the plurality of time points following the initiation of the process for manufacturing the cell therapy product, the plurality of time points including the first and second time points.
10. The method of claim 4 , further comprising:
upon determining that the acceptance parameters at a given time point meet acceptance criteria at the given time point, determining a completion date for the manufacturing of the cell therapy;
generating, by the computing device, a schedule for patient treatment events including infusion of the cell therapy product in the patient based on the completion date;
transmitting, to a logistics subsystem, a pick-up order based on the completion date; and
transmitting, to a hospital-side subsystem, the schedule for the patient treatment events.
11. The method of claim 10 , wherein the schedule for patient treatment events includes one or more of an inpatient stay time period, resection date, lymphodepletion date, infusion date for infusing the patient with the cell therapy product and IL-2 treatment date.
12. The method of claim 10 , further comprising: scheduling, by the computing device, a provision of patient support services based on the schedule for patient treatment events, the provision of patient support services including provision of one or more of support for a patient's travel to and from a medical facility, transmission of requisite health insurance information, transmission of requisite financial reimbursement related information, and provision of treatment events-related services.
13. The method of claim 4 , wherein the cell order request to perform the multi-step cell expansion process is received from a hospital-side subsystem, and the method further comprises transmitting, upon receiving the cell order request, a confirmation, including one or both of the patient-specific identifier and the cell order identifier, to the hospital-side subsystem that the cell order request associated with the patient has been received.
14. The method of claim 4 , further comprising:
upon determining that the acceptance parameters at a given time point of the plurality of time points do not meet acceptance criteria at the given time point, determining an updated completion date for the process for manufacturing of the cell therapy;
rescheduling the patient treatment events based on the updated completion date; and
transmitting, upon rescheduling the patient treatment events, to a hospital-side subsystem an updated schedule for the patient treatment events associated with the patient-specific identifier.
15. The method of claim 14 , further comprising:
generating, by the computing device, an updated cell order identifier and an updated schedule for shipping and logistics events associated with the patient treatment events based on the rescheduling of the patient treatment events, and
transmitting the updated schedule of shipping and logistics events, the updated cell order identifier, and the associated patient-specific identifier to a logistics subsystem based on the rescheduling of shipping and logistics events.
16. The method of claim 14 , further comprising: scheduling, by the computing device, a provision of patient support services based on the updated schedule for the patient treatment events, the provision of patient support services including provision of one or more of support for a patient's travel to and from a medical facility, transmission of requisite health insurance information, transmission of requisite financial reimbursement related information, and provision of treatment events-related services.
17. The method of claim 4 , further comprising:
associating, by the computing device, with the patient-specific identifier at each of the plurality of time points at which a determination of whether the acceptance parameters meet acceptance criteria is made, an updated cell order identifier including the acceptance parameters for each corresponding time point and a result of the determination.
18. The method of claim 4 , wherein the container label comprises a graphical identification code encoding the cell order identifier, the patient-specific identifier, and information associated with the patient, the multi-step cell expansion process and quality of the cell therapy product, the graphical identification code being one of a 1-dimensional barcode and a 2-dimensional barcode.
19. The method of claim 4 , further comprising generating a contingent shipping label for a shipping container containing the cell therapy product before performing a final quality control assay, the contingent shipping label being indicative that the cell therapy product is not releasable unless a result of the final quality control assay indicates that the acceptance parameters meet corresponding acceptance criteria.