DRUG DELIVERY DEVICE
    11.
    发明申请

    公开(公告)号:US20250082858A1

    公开(公告)日:2025-03-13

    申请号:US18962542

    申请日:2024-11-27

    Applicant: AMGEN INC.

    Abstract: A single-use auto-injector includes a housing and a dosing unit in at least part of the housing. The dosing unit includes a needle, a drug container with drug, a piston movable in the container, a first mechanical power supply for moving the piston to deliver the drug, an activation mechanism, and a mechanical escapement mechanism for controlling the movement of the piston. The auto-injector has a first state in which the needle is protected from needle damage or contamination, a second state in which the needle is ready to penetrate a human body, a third state in which the needle has penetrated the human body and is ready to dose, and a fourth state in which the needle is shielded to avoid unintended needle sticks. A second mechanical power supply is configured to shift state of the auto-injector from the third state to the fourth state.

    FC-GAMMA RECEPTOR II BINDING AND GLYCAN CONTENT

    公开(公告)号:US20250076309A1

    公开(公告)日:2025-03-06

    申请号:US18698098

    申请日:2022-10-04

    Applicant: AMGEN INC.

    Abstract: Provided herein are methods of determining product quality of an antibody composition, wherein the product quality is based on the Fcγ receptor II (FcγRI) binding level of the antibody composition. In exemplary embodiments, the method comprises (a) determining the afucosylated glycan content and/or β-galactosylated glycan content of a sample of the antibody composition; (b) optionally, calculating a predicted FcγRII binding level based on the afucosylated glycan content and/or β-galactosylated glycan content as determined in (a); and (c) determining the product quality of the antibody composition as acceptable when (i) the afucosylated glycan content and/or β-galactosylated glycan content is within a target range and/or (ii) the predicted FcγRII binding level is within a target range. Related methods of monitoring product quality and methods of producing an antibody composition are further provided herein.

    Containers and systems for use during external sterilization of drug delivery devices

    公开(公告)号:US12240652B2

    公开(公告)日:2025-03-04

    申请号:US17183515

    申请日:2021-02-24

    Applicant: AMGEN INC.

    Abstract: A container and systems for use during an external sterilization process of a plurality of drug delivery devices are provided. The container may include an outer housing and at least one partition at least partially enclosed by the outer housing. The at least one partition may include a plurality of first dividers and a plurality of second dividers. The at least one partition may also be positioned an open configuration, wherein the plurality of first dividers and the plurality of second dividers cooperate with each other to define a plurality of chambers configured to receive at least one of the plurality of drug delivery devices. The at least one partition may also be positioned in a closed configuration wherein the plurality of chambers are substantially completely collapsed.

    INJECTION SYSTEMS FOR DRUG DELIVERY WITH INTERNAL FORCE TRANSMISSION

    公开(公告)号:US20250050026A1

    公开(公告)日:2025-02-13

    申请号:US18931635

    申请日:2024-10-30

    Applicant: AMGEN INC.

    Abstract: Injection systems for drug delivery are disclosed. A system may include a container filled or fillable with a drug, a stopper movably disposed in the container, a plunger, an energy source outputting a force, a mechanical linkage operable to transmit the force output by the energy source to the plunger to cause the plunger to act on the stopper to expel the drug from the container, and a trigger member. The system may have pre-injection state where the trigger member inhibits actuation of the mechanical linkage, an injection state where the trigger member permits actuation of the mechanical linkage, and a post-injection state where the plunger is stationarily positioned in an end-of-dose position. The system may be designed to limit the number of components included in various force transmission loops present in the pre-injection, injection, and/or post-injection states.

    Robotic system for performing pattern recognition-based inspection of pharmaceutical containers

    公开(公告)号:US12214383B2

    公开(公告)日:2025-02-04

    申请号:US18235419

    申请日:2023-08-18

    Applicant: AMGEN INC.

    Abstract: A robotic inspection platform comprises a robotic arm, an imager, and a controller. The controller causes the robotic arm to retrieve, using its end effector, a container, and to manipulate the container such that the container is sequentially placed in a plurality of orientations while in view of the imager. The controller also causes the imager to capture images, with each of the images being captured while the container is in a respective one of the orientations. The controller also determines one or more attributes of the container, and/or a sample within the container, by analyzing the images using a pattern recognition model and, based on the attribute(s), determines whether the container and/or sample satisfies one or more criteria. If the container and/or sample fails to satisfy the criteria, the controller causes the robotic arm to place the container in an area (e.g., bin) reserved for rejected containers and/or samples.

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