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公开(公告)号:US11826480B2
公开(公告)日:2023-11-28
申请号:US16179399
申请日:2018-11-02
Applicant: AMGEN INC.
Inventor: Loic Barbedette , Shaun Devitt , Wael Mismar
IPC: A61L2/00 , G01N21/00 , A61L2/08 , A61M5/28 , A61M5/00 , B65B3/00 , B65B55/08 , A61L2/26 , G21F1/02 , G21F1/06 , G21F1/08
CPC classification number: A61L2/08 , A61L2/081 , A61L2/087 , A61L2/26 , A61M5/008 , A61M5/285 , B65B3/003 , B65B55/08 , G21F1/02 , G21F1/06 , G21F1/08 , A61L2202/23 , A61M5/001 , A61M5/002
Abstract: A drug delivery sterilization system includes a housing defining at least one receptacle, a container assembly having first and second ends, an elongated portion extending therebetween, and an electron beam or x-ray generator disposed near the housing. The container assembly includes a container having a container contact region at the second end and an inner volume to contain a medicament, a seal member having a seal member contact region to form a sealing interface with the container contact region, and a coupling device adapted to sealingly couple the seal member to the container. The container assembly is at least partially disposed in the receptacle such that the second end of the container is exposed through the housing. The electron beam or x-ray generator generates a sterilizing beam that penetrates the seal member to sterilize the sealing interface.
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公开(公告)号:US20230372607A1
公开(公告)日:2023-11-23
申请号:US18226414
申请日:2023-07-26
Applicant: AMGEN INC.
Inventor: Yasaman Damestani , Lawrence S. Ring
CPC classification number: A61M5/1456 , A61M5/24 , A61J1/2024 , A61J1/1406 , A61M5/285
Abstract: Drug delivery devices and related methods of assembly are disclosed. The drug delivery device may include a housing and a container disposed therein. The container may include a reservoir containing a drug and a movable stopper. A first seal member may be connected to the container at a distal end of the reservoir. A first removable membrane may cover an exterior surface of the first seal member to maintain sterility of that surface prior to operation of the device. A fluid pathway assembly may be configured to establish fluid communication with the reservoir during operation of the device. A second seal member may be connected to a first end of the fluid pathway assembly. A second removable membrane may cover an exterior surface of the second seal member to maintain sterility of that surface prior to operation of the device.
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公开(公告)号:US20230357753A1
公开(公告)日:2023-11-09
申请号:US18026264
申请日:2021-09-09
Applicant: AMGEN INC.
Inventor: Huong Thi Ngoc Le , Jasmine Tat , Ewelina Zasadzinska
CPC classification number: C12N15/1034 , C12M41/48 , G16B25/10
Abstract: Methods and systems for determining a minimum number of cell line clones necessary to produce a product having a set of target product attributes are disclosed. An example method includes generating at least one cell line capable of expressing a polypeptide; measuring, using one or more analytical instruments, a plurality of measured product attribute values of a plurality of clones of a candidate cell line; receiving inputs, via a user interface, representing a set of target product attribute values for a product; projecting, by one or more processors based upon the plurality of measured values, a minimum number of subject clones of the product using the candidate cell line necessary to produce a subset of the subject clones having product attributes that satisfy one or more conditions associated with the set of target values; and generating the projected minimum number of subject clones of the product using the candidate cell line.
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公开(公告)号:US20230355615A1
公开(公告)日:2023-11-09
申请号:US18313267
申请日:2023-05-05
Applicant: Amgen Inc. , Cytokinetics, Inc.
Inventor: Narimon HONARPOUR , Fady MALIK
IPC: A61K31/496 , A61K9/00 , A61P9/04
CPC classification number: A61K31/496 , A61K9/0053 , A61P9/04
Abstract: Provided herein are methods of treating a subject with heart failure, comprising administering to the subject an initial dose of a cardiac sarcomere activator (CSA) for an initial time period, and subsequently administering to the subject a dose of the CSA based on the subject's plasma concentration of the CSA at the end of the initial time period.
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公开(公告)号:US11807693B2
公开(公告)日:2023-11-07
申请号:US17160819
申请日:2021-01-28
Applicant: AMGEN INC.
Inventor: Jerry Ryan Holder , Gayathri Swaminath , Michael J. Frohn , Brian Alan Lanman , Anthony B. Reed , Leslie P. Miranda , John Gordon Allen , Alexander J. Pickrell , Aaron C. Siegmund , Lewis D. Pennington , Bryant Yang
CPC classification number: C07K7/08 , A61K38/10 , A61K47/542 , A61K47/60 , C07K14/47 , A61K38/00 , C07K2319/30
Abstract: The invention provides modified apelin polypeptides having increased stability, circulating half-life, and/or potency relative to the native apelin-13 polypeptide. Compositions comprising the modified apelin polypeptides and methods of using the polypeptides for treating cardiac disorders, such as heart failure, are also disclosed.
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公开(公告)号:US11780914B2
公开(公告)日:2023-10-10
申请号:US17031674
申请日:2020-09-24
Applicant: AMGEN INC.
Inventor: Agnes E. Hamburger , Cen Xu , Hong Sun , Yuan D. Shih , Dohan Weeraratne
CPC classification number: C07K16/26 , A61P25/06 , C07K16/4283 , A61K9/0019 , A61K2039/505 , C07K2317/24 , C07K2317/34 , C07K2317/565 , C07K2317/76
Abstract: The present invention relates to monoclonal antibodies that specifically bind to human pituitary adenylate cyclase activating polypeptide (PACAP) and pharmaceutical compositions comprising such antibodies. Methods of treating or preventing headache conditions, such as migraine and cluster headache, using the monoclonal antibodies are also described.
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公开(公告)号:US11771844B2
公开(公告)日:2023-10-03
申请号:US17685433
申请日:2022-03-03
Applicant: AMGEN INC.
Inventor: Jeffrey C. Yeary
CPC classification number: A61M5/3204 , A61M5/002
Abstract: A syringe de-capper including a base having a lower surface and an upper surface opposite the lower surface. The syringe de-capper also includes a de-capping member extending from the upper surface of the base, the de-capping feature including a proximal end adjacent to the base, a distal end spaced away from the base. The de-capping feature includes opposing first and second lateral surfaces defining a proximal thickness at the proximal end and a distal thickness at the distal end, the distal thickness is smaller than the proximal thickness. Also, the syringe de-capper includes a slot disposed in the de-capping member, the slot extending from the distal end of the de-capping member toward the proximal end of the de-capping member and configured to slidably receive a distal end of a syringe for removing a cap therefrom.
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公开(公告)号:US20230302264A1
公开(公告)日:2023-09-28
申请号:US18022245
申请日:2021-09-02
Applicant: AMGEN INC.
Inventor: Mehran Mojarrad , Scott R. Gibson , Scott Castanon , Robert Eisele , Dylann Ceriani
CPC classification number: A61M31/002 , A61M37/0015
Abstract: A swallowable drug delivery device includes a capsule and a tissue attachment member. The capsule may contain a drug and may be sized to pass through at least a portion of the gastrointestinal tract of a patient. The tissue attachment member may be coupled to the capsule. In an initial state, the tissue attachment member may allow the capsule to pass through the at least a portion of the gastrointestinal tract of the patient. In an activated state, the tissue attachment member is configured to at least selectively attach the capsule to a wall of the gastrointestinal tract of the patient. The tissue attachment member may be configured to change from the initial state to the activated state in response to an in vivo condition associated with a predetermined location in the gastrointestinal tract of the patient.
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公开(公告)号:US20230295267A1
公开(公告)日:2023-09-21
申请号:US18206963
申请日:2023-06-07
Applicant: AMGEN INC.
Inventor: Jeonghoon SUN , Lei-Ting Tony TAM , Mark Leo MICHAELS , Thomas Charles BOONE , Rohini R. DESHPANDE , Yue-Sheng LI , Huiquan HAN
IPC: C07K14/71 , C07K14/495
CPC classification number: C07K14/71 , C07K14/495 , A61K38/00
Abstract: The present invention provides stabilized activin IIB receptor polypeptides and proteins capable of binding and inhibiting the activities of activin A, myostatin, or GDF-11. The present invention also provides polynucleotides, vectors and host cells capable of producing the stabilized polypeptides and proteins. Compositions and methods for treating muscle-wasting diseases and metabolic disorders are also provided.
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公开(公告)号:US11759571B2
公开(公告)日:2023-09-19
申请号:US17072618
申请日:2020-10-16
Applicant: AMGEN INC.
Inventor: Scott R. Gibson
CPC classification number: A61M5/2466 , A61M5/3202 , A61M5/3297 , B65B3/003 , A61M2005/247 , A61M2005/2474 , A61M2005/3118
Abstract: An injector may include a container having a wall with an interior surface defining a closed sterile reservoir filled with a drug product. The injector may also include a fluid delivery system comprising a sterile container needle that is in fluid communication with the container in a delivery state, but may or may not be in fluid communication with the container in a storage state. Further, the injector may include an actuator that is adapted to move the container needle from the storage state to the delivery state.
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