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    SYSTEMS AND METHODS FOR REDUCING LAB-TO-LAB AND/OR INSTRUMENT-TO-INSTRUMENT VARIABILITY OF MULTI-ATTRIBUTE METHOD (MAM) BY RUN-TIME SIGNAL INTENSITY CALIBRATIONS
    1.
    发明申请
    SYSTEMS AND METHODS FOR REDUCING LAB-TO-LAB AND/OR INSTRUMENT-TO-INSTRUMENT VARIABILITY OF MULTI-ATTRIBUTE METHOD (MAM) BY RUN-TIME SIGNAL INTENSITY CALIBRATIONS 有权

    公开(公告)号：US20210265147A1

    公开(公告)日：2021-08-26

    申请号：US16972742

    申请日：2019-06-06

    Applicant: AMGEN INC.

    Inventor： Zhongqi ZHANG

    IPC: H01J49/00 ,  G01N30/86

    Abstract: Systems and methods are described for reducing lab-to-lab and/or instrument-to-instrument variability of Multi-Attribute Methods (MAM) analyses via run-time signal intensity calibration. In various aspects, multiple MAM-based instruments each have detectors and different instrument conditions defined by different instrument models or sets of settings. Each MAM-based instrument receives respective samples and a reference standard as a calibrant. Each MAM-based instrument detects, via its detector, sample isoforms of its respective sample and reference standard isoforms of the reference standard. The MAM-based instruments are associated with processor(s) that determine, via respective MAM iterations, correction factors and sample abundance values corresponding to the sample isoforms. The correction factors are based on the reference standard, and the sample abundance values are based on the correction factors. A variance value of the sample abundance values may be reduced based on correction factors of each of the MAM-based instruments.

    Methods of Manufacturing Biological Therapies
    3.
    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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