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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.
Inventor: Hans Stenberg Knudsen , Christian Plambech , Rasmus Øhlenschlæger , Jørgen Jørgensen
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.
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公开(公告)号:US12247071B2
公开(公告)日:2025-03-11
申请号:US17820958
申请日:2022-08-19
Applicant: Amgen Inc.
Inventor: William J. Callahan , Rahul Rajan Kaushik , Joy Brennan
Abstract: Stable adalimumab formulations are disclosed.
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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.
Inventor: Palanisamy KANAKARAJ , Katariina HUTTERER , Scott KUHNS
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.
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公开(公告)号:US20250074855A1
公开(公告)日:2025-03-06
申请号:US18291294
申请日:2022-08-17
Applicant: AMGEN INC.
Inventor: Adrian ORTIZ , Athimoolam ARUNACHALAMPILLAI
Abstract: The present invention relates to stereoselective process for the preparation of a compound having formula (2) and (1) wherein X is defined in the specification.
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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.
Inventor: Anthony Bitong , Jessica Liu , Mads Schjoth Due , Wael Mismar , Greg Payne
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.
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公开(公告)号:US12233177B2
公开(公告)日:2025-02-25
申请号:US17022695
申请日:2020-09-16
Applicant: AMGEN INC.
Inventor: Wael Mismar , Jessica Hai Liu , Chia-Jung Wu , Shermeen A. Abbas , Shaun Devitt , Kenneth G. Schalhoub , Anthony Bitong , Mads Schjoth Due , Malak Guirguis , Rami Saifan
Abstract: A method of externally sterilizing a drug delivery device utilizing Nitrogen Dioxide (NO2) is provided, including placing the drug delivery device in a sterilization chamber, introducing into the chamber a dose of NO2 having a concentration of between about 2 and 20 milligrams per Liter by applying a vacuum level of between about 10 and 600 Torr and holding the vacuum level for a dwell time of between about 2 and 20 minutes, repeating the step of introducing into the chamber a dose of NO2 for a number of pulses between about 1 and 24, purging the sterilization chamber of at least substantially all of the NO2, and aerating the sterilization chamber.
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公开(公告)号:US20250059179A1
公开(公告)日:2025-02-20
申请号:US18696948
申请日:2022-04-28
Applicant: AMGEN INC.
Inventor: Brian Alan Lanman , Ryan Paul Wurz , Wei Zhao , Xiaofen Li , Michael M. Yamano , Yunxiao Li , Ning Chen , Sebastian Leth-Petersen , Kexue Li , Liping Pettus , Rene Rahimoff , Primali Vasundera Navaratne , Huan Rui
IPC: C07D417/14 , A61K31/517 , A61K31/5377 , A61K31/5383 , A61K31/5386 , A61K31/541 , A61K31/55 , A61K31/551 , C07D471/04 , C07D471/08 , C07D487/04 , C07D487/10 , C07D487/20 , C07D498/04 , C07D498/10 , C07D519/00
Abstract: The present disclosure provides compounds useful for the inhibition of KRAS G12D. The compounds have a general Formula I: (I) wherein the variables of Formula I are defined herein. This disclosure also provides pharmaceutical compositions comprising the compounds, uses of the compounds, and compositions for treatment of, for example, cancer.
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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.
Inventor: Christian PLAMBECH , Matias MELANDER
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.
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19.
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.
Inventor: Dmitry Fradkin , Thomas Clark Pearson , Neelima Chavali , Erwin Freund
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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公开(公告)号:US20250032608A1
公开(公告)日:2025-01-30
申请号:US18909660
申请日:2024-10-08
Applicant: AMGEN INC. , MEDIMMUNE, LLC
Inventor: Jane R. Parnes , Janet Griffiths
IPC: A61K39/395 , A61K39/00 , A61P11/06 , C07K16/24
Abstract: The present disclosure, relates, in general, to methods of treating asthma, including severe asthma and eosinophilic asthma, using an antibody specific for thymic stromal lymphopoietin (TSLP).
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