IP Library Granted Patent US 12697282
Granted Patent B2
US 12697282 · App. 18/275,532 · Granted Aug 4, 2026

High-throughput automated reconstitution of lyophilized drug product

Inventors: Russell Blake Umstead (Thousand Oaks, CA); Nicholas Guziewicz (Somerville, MA)
Assignee: AMGEN INC.
A61J1/2003A61J1/16B01J19/004B25J9/1666B01J2219/00313B01J2219/00351B01J2219/00691
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12697282
App. No.
18/275,532
Granted
Aug 4, 2026
Kind
B2
Abstract

A drug product reconstitution processing system includes a drug vial tray having a plurality of walls, a first robotic arm movable between a plurality of positions above the drug vial tray, and a second robotic arm movable between a plurality of positions above the drug vial tray. The first robotic arm includes a drug vial transfer system adapted to retrieve a drug vial disposed within one of the plurality of wells and a vial agitation system adapted to agitate the drug product contained within the drug vial. The second robotic arm includes a drug vial reconstitution system adapted to selectively add a fluid to the drug vial and/or remove a fluid from the drug vial.

Claims (28)

1 . A drug product reconstitution processing system comprising:

a drug vial tray . . .

a first robotic arm . . . including . . . a drug vial transfer system . . . and a vial agitation system . . .

a second robotic arm . . . the second robotic arm including a needle and a drug vial reconstitution system adapted to selectively add a fluid to the drug vial and/or remove a fluid from the drug vial via the needle; and

a collision detection system adapted to identify whether the first robotic arm may contact the second robotic arm in response to a command to move the first robotic arm or the second robotic arm,

wherein the collision detection system is adapted to cause a controlled movement of the entirety of the first robotic arm and the grasping member as a unit or the entirety of the second robotic arm and the needle as a unit along a coordinated path in generally opposite directions within the defined mechanical constraints and motion parameters of the system in response to identifying that the first robotic arm may contact the second robotic arm while maintaining concurrent operation of the vial agitation system and the drug vial reconstitution system.

2 . The drug product reconstitution processing system of claim 1 , wherein the agitation system comprises at least one motor, a memory configured to store non-transitory computer executable instructions, and a processor configured to interface with the memory, wherein the processor is configured to execute the non-transitory computer executable instructions to cause the processor to initiate the at least one motor to move according to an agitation routine.

3 . The drug product reconstitution processing system of claim 2 , wherein the agitation routine comprises moving the drug vial in a lateral direction, moving the drug vial in an axial direction, and rotating the drug vial about an axis.

4 . The drug product reconstitution processing system of claim 1 , wherein the drug transfer system comprises at least one motor, a memory configured to store non-transitory computer executable instructions, and a processor configured to interface with the memory, wherein the processor is configured to execute the non-transitory computer executable instructions to cause the processor to initiate the at least one motor to move to transfer the drug vial to a different one of the plurality of wells.

5 . The drug product reconstitution processing system of claim 1 , wherein the collision detection system is adapted to compare a desired movement location of the first robotic arm or the second robotic arm with a location of the second robotic arm or the first robotic arm, respectively.

6 . The drug product reconstitution processing system of claim 1 , wherein the vial agitation system and the drug vial reconstitution system may operate concurrently.

7 . A drug product reconstitution processing system comprising:

a drug vial tray . . .

a first robotic arm . . . including a grasping member, a drug vial transfer system . . . , and a vial agitation system . . .

a second robotic arm . . . the second robotic arm including a needle and a drug vial reconstitution system adapted to selectively add a fluid to the drug vial and/or remove a fluid from the drug vial via the needle;

a memory . . . and a processor . . . the processor is adapted to execute the non-transitory computer executable instructions to cause the processor to initiate a collision detection system adapted to identify whether the first robotic arm may contact the second robotic arm in response to a command to move the first robotic arm or the second robotic arm,

wherein the collision detection system is adapted to cause a controlled movement of the entirety of the first robotic arm and the grasping member as a unit or the entirety of the second robotic arm and the needle as a unit along a coordinated path in generally opposite directions in response to identifying that the first robotic arm may contact the second robotic arm while maintaining concurrent operation of the vial agitation system and the drug vial reconstitution system.

8 . The drug product reconstitution processing system of claim 7 , wherein the collision detection system is adapted to compare a desired well location of the first robotic arm or the second robotic arm with a location of the second robotic arm or the first robotic arm, respectively.

9 . The drug product reconstitution processing system of claim 8 , wherein the collision detection system applies a distance buffer to the compared desired movement location of the first robotic arm or the second robotic arm with a location of the second robotic arm or the first robotic arm, respectively.

10 . The drug product reconstitution processing system of claim 7 , wherein the vial agitation system includes at least one motor, wherein the processor is configured to execute the non-transitory computer executable instructions to cause the processor to initiate the at least one motor to move according to an agitation routine.

11 . The drug product reconstitution processing system of claim 10 , wherein the agitation routine comprises moving the drug vial in a lateral direction, moving the drug vial in an axial direction, and rotating the drug vial about an axis.

12 . A computer-implemented method, carried out by an automated drug product reconstitution processing system, for reconstituting a drug product comprising:

receiving . . . an instruction to execute a command;

receiving . . . location data corresponding to a location of a first robotic arm including a grasping member and a vial agitation system coupled therewith, a second robotic arm including a needle and a drug vial reconstitution system coupled therewith, and a desired location of the first robotic arm or the second robotic arm based on the received command;

determining, by a collision detection system of the automated drug reconstitution product processing system, automatically from the set of location data, whether the first robotic arm may contact the second robotic arm upon executing the command; and

in response to determining whether the first robotic arm may contact the second robotic arm upon executing the command, selectively executing the command or initiating a collision avoidance routine to cause a controlled movement of the entirety of the first robotic arm and the grasping member as a unit or the entirety of the second robotic arm and the needle as a unit along a coordinated path in generally opposite directions while maintaining concurrent operation of the vial agitation system and the drug vial reconstitution system.

13 . The computer-implemented method of claim 12 , wherein the step of determining further comprises applying a distance buffer to the compared desired movement location of the first robotic arm or the second robotic arm with a location of the second robotic arm or the first robotic arm, respectively.

14 . The computer-implemented method of claim 12 , wherein the command comprises at least one of initiating a drug vial transfer system, initiating a drug vial agitation system, or initiating a drug vial reconstitution system.