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    LYOPHILIZATION SYSTEM/LYOPHILIZER
    51.
    发明公开
    LYOPHILIZATION SYSTEM/LYOPHILIZER 审中-公开

    公开(公告)号：US20240263875A1

    公开(公告)日：2024-08-08

    申请号：US18564675

    申请日：2022-05-24

    Applicant: AMGEN INC.

    Inventor： Philippe Lam ,  Gioval Scalzo ,  Nitin Rathore

    IPC: F26B5/06 ,  F26B5/04

    CPC classification number: F26B5/06 ,  F26B5/044

    Abstract: A method of lyophilizing a target material includes placing a container with a target material in a lyophilizer of a lyophilization system. The lyophilization system includes the lyophilizer, a refrigeration system coupled to the lyophilizer, a temperature controller coupled to the refrigeration system, and a flow path connecting the lyophilizer and the refrigeration system. The method includes activating the lyophilizer where the lyophilizer includes a plurality of walls defining an interior chamber and at least one shelf disposed in the interior chamber. The method includes running a freezing cycle, running a primary drying cycle, and running a secondary drying cycle. The method includes pumping a thermal fluid through the flow path in fluid communication with the at least one shelf and at least one wall. Running the freezing cycle includes pumping the thermal fluid through the at least one wall of the plurality of walls.

    On-body injector
    53.
    外观设计
    On-body injector 有权

    公开(公告)号：USD1038379S1

    公开(公告)日：2024-08-06

    申请号：US29723031

    申请日：2020-02-04

    Applicant: AMGEN INC.

    Designer： Brian Stonecipher ,  Peter V. Shultz ,  Lisa Nugent ,  Margaux Frances Boyaval ,  Sigrid Moeslinger ,  Masamichi Udagawa

    Abstract: FIG. 1 is a perspective view showing a new design for an on-body injector;
    FIG. 2 is a right side view of the on-body injector of FIG. 1;
    FIG. 3 is a left side view of the on-body injector of FIG. 1;
    FIG. 4 is a rear view of the on-body injector of FIG. 1;
    FIG. 5 is a front view of the on-body injector of FIG. 1;
    FIG. 6 is a top view of the on-body injector of FIG. 1; and,
    FIG. 7 is a bottom view of the on-body injector of FIG. 1.

    ADVERSE EFFECTS-MITIGATING ADMINISTRATION OF A BISPECIFIC CONSTRUCT BINDING TO CD33 AND CD3
    56.
    发明公开
    ADVERSE EFFECTS-MITIGATING ADMINISTRATION OF A BISPECIFIC CONSTRUCT BINDING TO CD33 AND CD3 审中-公开

    公开(公告)号：US20240209085A1

    公开(公告)日：2024-06-27

    申请号：US17927071

    申请日：2021-05-31

    Applicant: AMGEN INC.

    Inventor： Sophia K. Khaldoyanidi ,  Dirk Nagorsen

    IPC: C07K16/28 ,  A61K39/00 ,  A61P35/02

    CPC classification number: C07K16/2809 ,  A61P35/02 ,  C07K16/2803 ,  A61K2039/545 ,  C07K2317/31 ,  C07K2317/622

    Abstract: The present invention provides a bispecific construct comprising a first binding domain specifically binding to a target such as CD33 and a second binding domain specifically binding to an effector such as CD3 for use in a method for the treatment of myeloid leukemia, wherein the construct is administered in one or more treatment cycles of more than 14 days applying a step dosing comprising at least two, preferably steps, wherein the first step is higher than the second step with respect to the previous dosage, and wherein the second step is higher than the optional but preferred third step with respect to the previous dosage, a treatment cycle optionally followed by a period without administration of the construct. Moreover, the invention provides a method for the treatment of myeloid leukemia comprising the administration of a therapeutically efficient amount of such bispecific construct and the use of such bispecific construct for the preparation of a pharmaceutical composition for the treatment of myeloid leukemia.

    Methods of Manufacturing Biological Therapies
    60.
    发明公开
    Methods of Manufacturing Biological Therapies 审中-公开

    公开(公告)号：US20240197922A1

    公开(公告)日：2024-06-20

    申请号：US18333607

    申请日：2023-06-13

    Applicant: AMGEN INC.

    Inventor： Nathan JOH ,  Marisa JOUBERT ,  Gerd Richard KLEEMAN ,  Linda Owers NARHI ,  Noel J. RIEDER ,  Joshua TOKUDA ,  Zhongqi ZHANG ,  Yunlong ZHANG

    IPC: A61K49/00

    CPC classification number: A61K49/0004

    Abstract: Methods of manufacturing a biological therapy are described. The methods can comprise detecting a level of a molecular attribute of the biological therapy in a formulation, determining a rate of change of the molecular attribute under the storage conditions, and estimating a level of molecular attribute exposure received by the subjects at the time of said administration. Production lots of the biological therapy comprising the molecular attribute can be manufactured comprising the molecular attribute at or below a specified specification for permissible levels of the molecular attribute based on the estimated level of molecule attribute exposure. Methods of developing a manufacturing process for a biological therapy are described. Methods of assessing the clinical impact of a molecular attribute of a biological therapy are described.

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