Automated device for a 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 . An automated device comprising:
a storage chamber for storing a biologic drug;
a processing compartment;
a system for receiving authorization to transfer the biologic drug from the storage chamber to the processing compartment; and
a dispensing chamber for receiving the biologic drug after processing.
2 . The device of claim 1 wherein the storage chamber comprises a freezer for maintaining the biologic drug at a desired temperature.
3 . The device of claim 2 wherein the freezer maintains the biologic drug at about −70° C.
4 . The device of claim 1 wherein the processing compartment comprises apparatus and materials for processing the biologic drug for administration to a patient.
5 . The device of claim 4 wherein the processing comprises thawing, washing, mixing, crosslinking, incubating, formulating and combinations thereof.
5 . The device of claim 4 wherein the processing compartment comprises thawing apparatus and materials, washing apparatus and materials, mixing apparatus and materials, crosslinking apparatus and materials, incubation apparatus and materials, formulating apparatus and materials and combinations thereof.
7 . The device of claim 1 wherein the system further comprises an internet connection for transmitting patient information to a computer at a remote location.
8 . The device of claim 1 wherein the system receives authorization through the internet connection.
9 . The device of claim 1 wherein the authorization is by entry of a code.
10 . The device of claim 9 wherein the code is entered in a computer at a remote location.
11 . The device of claim 1 wherein the code is entered through a keypad on the device.
12 . The device of claim 1 wherein the storage chamber holds multiple doses of the biologic drug.
13 . The device of claim 1 wherein the biologic drug comprises living cells.
14 . The device of claim 1 wherein the biologic drug comprises immune cells.
15 . The device of claim 1 wherein the biologic drug comprises activated T-cells.
16 . The device of claim 1 wherein the device is located at a point of care site.
17 . 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.
18 . The method of claim 17 wherein the biologic drug is manufactured at a remote location, stored for long term storage and transported for placement in the automated device.
19 . The method of claim 17 wherein the biologic drug is stored at about −70° C.
20 . The method of claim 17 wherein authorization comprises approval of a patient for receiving the biologic drug.
21 . The method of claim 17 wherein the authorization step comprises receiving authorization from a remote computer through an internet connection in the automated device.
22 . The method of claim 17 wherein the processing comprises thawing, washing, mixing, crosslinking, incubating, formulating and combinations thereof.
23 . The method of claim 17 wherein the biologic drug regains biological activity after the processing.
24 . The method of claim 17 wherein the biologic drug comprises living cells.
25 . The method of claim 17 wherein the biologic drug comprises immune cells.
26 . The method of claim 17 wherein the biologic drug comprises activated T-cells.
27 . The method of claim 17 wherein the biologic drug comprises activated T-cells and processing comprises reactivation of the T-cells prior to administration to a patient.
28 . 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.
29 . The method of claim 28 wherein the method further comprises processing the biologic drug in the automated device for administration to a patient.
30 . The method of claim 28 wherein the biologic drug is frozen after manufacturing and remains frozen during transportation to the point of care site.
31 . The method of claim 28 wherein the biologic drug comprises living cells.
32 . The method of claim 28 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.