Cell processing techniques
View Patent ↗The present disclosure relates to cell processing techniques. By way of example, a cell processing system may include a plurality of tracking devices coupled to a respective plurality of sample processing containers and storing sample identification information for a patient sample for use with sample processing devices configured to process the patient sample according to workflow steps of a processing protocol. A plurality of readers are configured to receive signals from the plurality of tracking devices. A controller may be coupled to the plurality of readers and configured to determine if the patient sample is processed according to the processing protocol based at least in part on the signals from the plurality of tracking devices.
1. A cell therapy manufacturing tracking system, comprising:
a cell therapy sample;
a sample container configured to hold the cell therapy sample;
a reader co-located with a sample processing location and configured to receive an identification signal from a first tracking device coupled to the sample container;
a sample processing device configured to process the cell therapy sample;
a second tracking device coupled to the sample processing device;
a controller operatively coupled to the reader and configured to:
access a cell therapy processing protocol associated with the identification signal upon receipt of the identification signal;
determine if the cell therapy sample is being processed according to the processing protocol;
provide an error signal to the sample processing device when the cell therapy sample is not being processed according to the processing protocol;
provide a verification signal to the sample processing device when the cell therapy sample is being processed according to the processing protocol;
prevent continuing operation of the sample processing device based on the error signal; and
permit continuing operation of the sample processing device based on the verification signal;
wherein one or both of the error signal and the verification signal is based on signals from the first tracking device coupled to the sample container, the second tracking device coupled to the sample processing device, and a third tracking device coupled to an operator badge.
2. The system of claim 1 , wherein the sample processing location is associated with a sample processing device.
3. The system of claim 2 , wherein the controller is configured to determine if the cell therapy sample is being processed according to the processing protocol based on receiving one or more signals representative of a completion of prior steps before a step involving the sample processing device.
4. The system of claim 2 , wherein the sample processing device comprises a switch configured to permit operation of the sample processing device only when the verification signal is provided.
5. The system of claim 1 , wherein the controller is configured to start a clock when determining that the verification signal is provided.
6. The system of claim 5 , wherein the controller is configured to stop the clock upon receipt of a second signal from the tracking device or from an operator.
7. The system of claim 1 , wherein the controller is configured to provide an error message when a step associated with the tracking device is performed and is not part of the processing protocol or varies from a step sequence of the processing protocol.
8. The system of claim 1 , wherein the controller is configured to determine if the cell therapy sample is being processed according to the processing protocol based on the identifier signal associated with the sample processing container.
9. The system of claim 8 , wherein the controller is configured to provide an error message when a step involving the sample processing container is not part of the processing protocol or varies from a step sequence of the processing protocol.
10. The system of claim 9 , wherein the controller is configured to provide an error message when the sample processing container or the cell therapy sample used together with the sample processing device is not part of the processing protocol.
11. The system of claim 1 , comprising a switch controlling operation of the sample processing device, wherein the controller is further configured to provide instructions associated with a processing protocol status, wherein the switch is configured to prevent operation of the sample processing device when the error signal is provided and based on the instructions.
12. The system of claim 1 , wherein the tracking device is an RFID tag.
13. The system of claim 12 , wherein the controller is further configured to provide instructions associated with a processing protocol status, and wherein, upon receiving the instructions, the sample processing device is configured to pause or prevent execution of routines for operation of the sample processing device.