CHARACTERIZATION APPARATUS FOR DRUG DELIVERY DEVICES OR SUBCOMPONENTS THEREOF

    公开(公告)号:WO2023064119A1

    公开(公告)日:2023-04-20

    申请号:PCT/US2022/045303

    申请日:2022-09-30

    Applicant: AMGEN INC.

    Abstract: Apparatuses, systems and methods are provided that characterize a rear sub-assembly for an autoinjector (Al). Apparatuses, systems and methods are also provided that generate injection time (IT) models for autoinjectors (Als). Autoinjectors (Als) (e.g., mechanical Als, spring-loaded Als, etc.), components for use within Als (e.g., prefilled syringes (PFS), rear sub-assemblies (RSAs), etc.), and related methods may utilize mathematical modeling along with design for six sigma (DFSS) and design for reliability and manufacturability (D RM) to establish upstream controls that ensure injection time (IT) robustness of mechanical autoinjectors (Als). For example, break-loose and extrusion (BLE) alert limit, rear sub-assembly (RSA) area under the curve (AUG), and RSA minimum force.

    ANTIBODY FORMULATIONS
    6.
    发明申请

    公开(公告)号:WO2023018870A1

    公开(公告)日:2023-02-16

    申请号:PCT/US2022/040056

    申请日:2022-08-11

    Applicant: AMGEN INC.

    Abstract: Provided herein are liquid compositions comprising a high concentration of a monoclonal antibody, e.g., greater than about 100 mg/mL, which demonstrate storage -stability and reduced viscosity. In exemplary embodiments, the liquid composition comprises about less than about 400 mM arginine glutamate, and, in alternative exemplary embodiments, the liquid composition comprises proline and a buffer.

    ASSESSING PACKED CELL VOLUME FOR CELL CULTURES

    公开(公告)号:WO2022260981A1

    公开(公告)日:2022-12-15

    申请号:PCT/US2022/032308

    申请日:2022-06-06

    Applicant: AMGEN INC.

    Abstract: A method of cell culture assessment (e.g., prior to a drug substance harvesting process) includes obtaining a plurality of parameters associated with a cell culture, and inferring or predicting a value or classification indicative of packed cell volume. Inferring or predicting the packed cell volume includes applying the plurality of parameters as inputs to a non-linear machine learning model. The method also includes generating an output indicative of the inferred or predicted value or classification.

Patent Agency Ranking