A METHOD OF PREDICTING RELATIVE FED BATCH PRODUCTION TITER OF A PANEL OF CLONALLY-DERIVED PRODUCER CELLS
    22.
    发明公开
    A METHOD OF PREDICTING RELATIVE FED BATCH PRODUCTION TITER OF A PANEL OF CLONALLY-DERIVED PRODUCER CELLS 审中-公开
    方法相对滴度FOR补料分批预测MANUFACTURING克隆二次电池制造商的板

    公开(公告)号:EP3099807A1

    公开(公告)日:2016-12-07

    申请号:EP14830805.9

    申请日:2014-12-17

    Abstract: A computer implemented method of predicting relative fed batch production titer of a panel of clonal producer cells derived from a single parental host cell population comprises the steps of assaying a level of growth of each clone in the presence and absence of one or more individual chemical cell stressors, comparing the level of growth of each clone in the presence and absence of the or each chemical cell stressor to provide a normalised production titer response for each clone in the or each stressed microenvironment, and inputting a clone-specific production titer response profile comprising the normalised production titer response for each clone in the or each stressed microenvironments into a computational model. The computational model is generated from production titer response profiles obtained from a calibration set of clones with known fed batch production titer, and is configured to output the predicted relative fed batch production titer of the panel of clonal cells.

    Abstract translation: 预测从一个单一的亲本宿主细胞群体衍生的克隆的生产细胞的面板的相对补料分批生产滴度的一种计算机实现的方法,包括:检测在一个或多个单独的化学电池的存在和不存在各克隆生长的水平的步骤 应激物在的存在和不存在或各化学细胞应激物比较每个克隆的生长水平,以提供在每个克隆一个获救生产滴度响应或每个强调微环境,以及输入特定克隆生产滴度响应简档包括 在所述或每个各克隆获救生产滴度响应强调微环境进入的计算模型。 计算模型是从校准组具有已知滴度补料分批生产克隆获得的生产滴度响应谱产生,并且被配置成输出克隆细胞的面板的预测相对补料分批生产滴度。

    METHOD FOR OPTIMIZING POST-TRANSLATIONAL MODIFICATIONS ON RECOMBINANT PROTEINS
    25.
    发明公开
    METHOD FOR OPTIMIZING POST-TRANSLATIONAL MODIFICATIONS ON RECOMBINANT PROTEINS 审中-公开
    方法以优化重组蛋白翻译后修饰

    公开(公告)号:EP3094639A1

    公开(公告)日:2016-11-23

    申请号:EP15734830.1

    申请日:2015-01-13

    Abstract: A method for optimizing post-translational modifications of recombinant proteins expressed in living cells is described. More particularly, a method for modulation of host proteins in living cells that control PTMs on recombinant proteins is described that has particularly useful applications in developing manufacturing process changes or in biosimilar development. The goal of this modulation is to produce a recipe for production of a recombinant protein in the new process or in the biosimilar that will produce a targeted PTM profile in the resulting protein product. In the method one or more modulators are selected, as from a modulator library, which affect the activity of host proteins. These modulators are added to media during production such that the resulting product matches the PTMs of the reference product. The ideal set of modulators and their concentrations are identified through a unique iterative process and the combined modulators and their concentrations constitute a recipe for growth media for the production of said recombinant protein. The methodology to obtain such a recipe described herein may then be used in many applications, such as optimizing new batches of recombinant protein drugs, developing biosimilar or bio-better drugs.

    NOVEL EUKARYOTIC CELLS AND METHODS FOR RECOMBINANTLY EXPRESSING A PRODUCT OF INTEREST
    27.
    发明公开
    NOVEL EUKARYOTIC CELLS AND METHODS FOR RECOMBINANTLY EXPRESSING A PRODUCT OF INTEREST 审中-公开
    中华人民共和国芬兰人民解放军总领事馆特别报告员

    公开(公告)号:EP3083676A1

    公开(公告)日:2016-10-26

    申请号:EP14821859.7

    申请日:2014-12-18

    Applicant: Novartis AG

    Abstract: The disclosure pertains to novel eukaryotic cell suitable for recombinant production of a product of interest, wherein the effect of the expression product of an endogenous gene C12orf35 is impaired in said cell, thereby increasing their productivity when recombinantly expressing a polypeptide of interest. Furthermore, the present disclosure provides associated technologies wherein such host cells are used in recombinant production technologies.

    Abstract translation: 本公开涉及适用于重组产生感兴趣的产物的新型真核细胞,其中所述细胞内内源基因C12orf35的表达产物的作用受损,从而在重组表达感兴趣的多肽时提高其生产力。 此外,本公开提供了其中这种宿主细胞用于重组生产技术的相关技术。

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