Systems and methods for coordinating manufacturing of cells for patient-specific immunotherapy

Patent metadata

Field	Value
Publication number	US-2021335467-A1
Application number	US-202117238092-A
Country	US
Kind code	A1
Filing date	Apr 22, 2021
Priority date	Apr 22, 2020
Publication date	Oct 28, 2021
Grant date	—

Abstract

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.

First claim

What is claimed is:

1 . A method of manufacturing a cell therapy product for treating cancer by expanding a population of cells obtained from a tumor from a patient into the cell therapy product, 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, cell order identifier including a patient-specific identifier associated with the cell order request; initiating a process to manufacture the cell therapy product, the process comprising:
after receiving the population of cells at a manufacturing facility, dynamically scheduling, by the computing device, patient treatment events, the dynamic scheduling being dependent on acceptance parameters for subsequently obtained expansion cell therapy product,
initiating expansion of the cell therapy product from at least some of the obtained population of cells using a cell expansion technique and determining acceptance parameters for the expansion cell therapy product,
determining whether the acceptance parameters for the expansion cell therapy product meet certain acceptance criteria,
in response to a determination that that the acceptance parameters for the expansion cell therapy product meet the acceptance criteria, completing the initial expansion of cell therapy, and
in response to a determination that the acceptance parameters for the expansion cell therapy product do not meet the acceptance criteria, rescheduling, by the computing device, the patient treatment events and completing a subsequent expansion of cell therapy product,
wherein the rescheduling the patient treatment events is performed based on a clinically determined time gap between an infusion of the expanded cell therapy product in the patient and patient treatment events prior to or subsequent to the infusion of the expanded cell therapy product in the patient.

2 . The method of claim 1 , wherein determining whether the acceptance parameters for the expansion cell therapy product meet certain acceptance criteria comprises determining acceptance parameters for the expansion cell therapy product at a first time point and at a second time point subsequent to the first time point, and determining whether acceptance parameters for the expansion cell therapy product meet certain acceptance criteria at the first time point and at the second time point, the method further comprising:
in response to a determination that the acceptance parameters for the expansion cell therapy product meet the acceptance criteria at the first time point, continuing the expansion of cell therapy product.

3 . The method of claim 2 , further comprising:
in response to a determination that the acceptance parameters for the expansion cell therapy product do not meet the acceptance criteria at the second time point: determining whether re-performing the expansion of the cell therapy product using the cell expansion technique is feasible from the first time point based on the acceptance parameters at the second time point, in response to a determination that the re-performing is feasible, re-performing the expansion of the cell therapy product from at least some of the cell therapy product obtained at the second time point using the cell expansion technique from the first time point to obtain the cell therapy product, estimating, by the computing device, a time of completion of the expansion of the cell therapy product following the re-performing of the expansion of the cell therapy product from the first time point; and rescheduling, by the computing device, the patient treatment events and completing a subsequent expansion of cell therapy product from the first time point, wherein the rescheduling of the patient treatment events is performed based on the estimated time of completion of the expansion of the cell therapy product and a timing of patient treatment events prior to or subsequent to an infusion of the expanded cell therapy product in the patient.

4 . The method of claim 1 , further comprising:
receiving, at a computing device, a cell order request to manufacture the cell therapy product for the patient, manufacturing slots at a plurality of manufacturing facilities for manufacturing the cell therapy product, wherein the manufacturing slots for a respective manufacturing facility are received at the computing device from a manufacturer computer subsystem associated with the respective manufacturing facility, and a preliminary schedule of patient treatment events for treating the patient with the cell therapy product; determining and displaying in a scheduling user interface, by the computing device, a plurality of available manufacturing slots for manufacturing the cell therapy product 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 a solid tumor from the patient in accordance with the preliminary schedule of patient treatment events and the available manufacturing slot; transferring the obtained solid tumor to a manufacturing facility corresponding to the available manufacturing slot in accordance with the available manufacturing slot; determining, during the manufacturing of the cell therapy product, acceptance parameters for the manufactured cell therapy product and whether the acceptance parameters meet acceptance criteria, the acceptance parameters being determined based on a result of an assay; modifying, by the computing device, a manufacturing schedule for manufacturing of the cell therapy product, manufacturing slots corresponding to the manufacturing facility, and the preliminary schedule of patient treatment events based on whether the acceptance criteria at one or both of the first and second time points are met; and completing the manufacturing of the cell therapy product in accordance with the modified manufacturing schedule, wherein determining whether the acceptance parameters for the manufactured cell therapy product meet acceptance criteria further comprises: determining, during the manufacturing of the cell therapy product, acceptance parameters for the manufactured cell therapy product at a first time point and a second time point subsequent to the first time point and whether the acceptance parameters meet acceptance criteria associated with a corresponding time point, the acceptance parameters being determined based on a result of an assay associated with the corresponding time point, the method further comprising completing the manufacturing of the cell therapy product in accordance with the modified manufacturing schedule if the acceptance criteria at both the first and second time points are met.

5 . The method of claim 2 , further comprising:
after receiving, at a manufacturing facility, a tumor obtained from a patient, generating, by a computing device, a manufacturing label for a manufacturing container to be used in a process for manufacturing the cell therapy product from at least a portion of the obtained solid tumor using a cell expansion technique, the manufacturing label comprising information associated with the patient, the manufacturing process and quality of manufactured cell therapy product; generating, by the computing device, an updated manufacturing label corresponding to each of a plurality of time points, the updated manufacturing label comprising updated information associated with quality of manufactured cell therapy product, the updated information comprising the acceptance parameters at a corresponding time point; reading, by the computing device, the updated manufacturing label at each of the plurality of time points; and completing expansion of the cell therapy product based on information rea

Assignees

• Iovance Biotherapeutics Inc

Inventors

• Brooks Anne
• Macrides Steve
• Lanzi Kristin

Classifications

• G16H80/00

  ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring · CPC title

• G16H40/20

  for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms · CPC title

• G16H20/17

  delivered via infusion or injection · CPC title

• G16H20/00 Primary

  ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance · CPC title

• G16H10/60

  for patient-specific data, e.g. for electronic patient records · CPC title