Automated device for biologic drug distribution
The present disclosure relates to an apparatus for dispensing biologic drug compositions. The apparatus includes an automated device that can store a biologic drug under the desired conditions. When authorized, the automated device can process the stored biologic drug by performing the desired processing steps to prepare the biologic drug for administration to a patient. The automated device may include a computing system to transmit patient information to a remote location and receive authorization from a remote location.
1. A method for dispensing a biologic drug comprising:
storing the biologic drug in an automated device under desired conditions; and
processing the biologic drug in the automated device upon receipt of authorization to process drug, wherein the automated device comprise, a storage chamber in a cooling unit for storing one or more doses of a biologic drug; a processing compartment within the automated device comprising one or more chambers for processing the one or more doses of the biologic drug, wherein the processing compartment comprises apparatus and materials in the one or more chambers for formulation of the biologic drug prior to administration to a patient; a system for receiving authorization to move the one or more doses of the biologic drug from the storage chamber to the one or more chambers of the processing compartment; and a dispensing chamber for receiving the biologic drug from the processing compartment.
2. The method of claim/wherein the biologic drug is manufactured at a remote location, stored for long term storage and transported for placement in the automated device.
3. The method of claim/wherein the biologic drug is stored at about −70° C.
4. The method of claim/wherein authorization comprises approval of a patient for receiving the biologic drug.
5. The method of claim 1 wherein the authorization step comprises receiving authorization from a remote computer through an internet connection in the automated device.
6. The method of claim 1 wherein the processing comprises thawing, washing, mixing, crosslinking, incubating, formulating and combinations thereof.
7. The method of claim 1 wherein the biologic drug regains biological activity after the processing.
8. The method of claim 1 wherein the biologic drug comprises living cells.
9. The method of claim 1 wherein the biologic drug comprises immune cells.
10. The method of claim 1 wherein the biologic drug comprises activated T-cells.
11. The method of claim 1 wherein the biologic drug comprises activated T-cells and processing comprises reactivation of the T-cells prior to administration to a patient.
12. A method for providing a biologic drug comprising:
manufacturing the biologic drug in a manufacturing facility;
transporting the biologic drug to a point of care site wherein the biologic drug is transported under conditions to maintain the biologic activity of the drug; and
storing the biologic drug in an automated device at the point of care site until a patient is authorized for receiving the biologic drug, wherein the automated device comprises a storage chamber in a cooling unit for storing one or more doses of a biologic drug; a processing compartment within the automated device comprising one or more chambers for processing the one or more doses of the biologic drug, wherein the processing compartment comprises apparatus and materials in the one or more chambers for formulation of the biologic drug prior to administration to a patient; a system for receiving authorization to move the one or more doses of the biologic drug from the storage chamber to the one more chambers of the processing compartment; and a dispensing chamber for receiving the biologic drug from the processing compartment.
13. The method of claim 12 wherein the method further comprises processing the biologic drug in the automated device for administration to a patient.
14. The method of claim 12 wherein the biologic drug is frozen after manufacturing and remains frozen during transportation to the point of care site.
15. The method of claim 12 wherein the biologic drug comprises living cells.
16. The method of claim 12 wherein the automated device comprises a computing system with an internet connection to transfer patient data and receive authorization to process the biologic drug for administration.