High-throughput automated reconstitution of lyophilized drug product

Patent metadata

Field	Value
Publication number	US-2024115462-A1
Application number	US-202218275532-A
Country	US
Kind code	A1
Filing date	Feb 1, 2022
Priority date	Feb 3, 2021
Publication date	Apr 11, 2024
Grant date	—

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.

First claim

1 . A drug product reconstitution processing system comprising:
a drug vial tray having a plurality of wells, each of the plurality of wells adapted to retain a drug vial including a drug product; a first robotic arm movable between a plurality of positions above the drug vial tray, the first robotic arm including 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; a second robotic arm movable between a plurality of positions above the drug vial tray, the second robotic arm including a drug vial reconstitution system adapted to selectively add a fluid to the drug vial and/or remove a fluid from the drug vial.

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

6 . The drug product reconstitution processing system of claim 5 , 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.

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

8 . A drug product reconstitution processing system comprising:
a drug vial tray having a plurality of wells, each of the plurality of wells adapted to retain a drug vial including a drug product; a first robotic arm movable between a plurality of positions above the drug vial tray, the first robotic arm including a drug vial transfer system adapted to move a drug vial between a desired well of the plurality of wells; a second robotic arm movable between a plurality of positions above the drug vial tray, the second robotic arm including a drug vial reconstitution system adapted to selectively add a fluid to the drug vial and/or remove a fluid from the drug vial; a memory adapted to store non-transitory computer executable instructions; and a processor adapted to interface with the memory, wherein upon receiving a command to initiate the drug vial transfer system or the drug vial reconstitution system, the processor is adapted to execute the non-transitory computer executable instructions to cause the processor to initiate a collision detection system.

9 . The drug product reconstitution processing system of claim 8 , 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.

10 . The drug product reconstitution processing system of claim 9 , 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.

11 . The drug product reconstitution processing system of claim 10 , wherein the collision detection system is adapted to move at least one of the first robotic arm or the second robotic arm in an opposite direction.

12 . The drug product reconstitution processing system of claim 8 , further comprising an agitation system including 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.

13 . The drug product reconstitution processing system of claim 12 , 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.

14 . A computer-implemented method, carried out by an automated drug product reconstitution processing system, for reconstituting a drug product comprising:
receiving, at the automated drug reconstitution processing system, an instruction to execute a command; receiving, at the automated drug reconstitution processing system, location data corresponding to a location of a first robotic arm, a second robotic arm, 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 will contact the second robotic arm upon executing the command; and in response to determining whether the first robotic arm will contact the second robotic arm upon executing the command, selectively executing the command or initiating a collision avoidance routine.

15 . The computer-implemented method of claim 14 , 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.

16 . The computer-implemented method of claim 14 , wherein the collision avoidance routine comprises moving at least one of the first robotic arm or the second robotic arm in an opposite direction.

17 . The computer-implemented method of claim 1 , 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.

Assignees

• Amgen Inc

Inventors

• Umstead Russell Blake
• Guziewicz Nicholas

Classifications

• A61J1/2003 Primary

  Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting · CPC title

• A61J1/16

  Holders for containers · CPC title

• B01J19/004

  Multifunctional apparatus for automatic manufacturing of various chemical products (sequential reactions B01J19/0046) · CPC title

• B25J9/1666

  Avoiding collision or forbidden zones · CPC title

• B01J2219/00313

  the reactor vessels being formed by arrays of wells in blocks · CPC title