USE OF RAMAN SPECTROSCOPY IN DOWNSTREAM PURIFICATION

    公开(公告)号:WO2020046793A1

    公开(公告)日:2020-03-05

    申请号:PCT/US2019/048100

    申请日:2019-08-26

    Abstract: In situ Raman spectroscopy methods and systems for characterizing or quantifying a protein purification intermediate and/or final concentrated pool during production or manufacture are provided. In one embodiment, in situ Raman spectroscopy is used to characterize or quantify protein purification intermediates critical quality attributes during downstream processing (i.e., after harvest of the protein purification intermediate). For example, the disclosed in situ Raman spectroscopy methods and systems can be used to characterize and quantify protein purification intermediates as the protein purification intermediates are purified, condensed, or otherwise formulated into the final drug product to be sold or administered

    PURIFICATION PLATFORM FOR BISPECIFIC ANTIBODIES
    3.
    发明申请
    PURIFICATION PLATFORM FOR BISPECIFIC ANTIBODIES 审中-公开
    双特异性抗体的纯化平台

    公开(公告)号:WO2016018740A3

    公开(公告)日:2016-02-04

    申请号:PCT/US2015/041936

    申请日:2015-07-24

    Abstract: High resolution protein A chromatography employing a chaotropic agent and pH gradient or pH step elution buffer results in improved peak resolution between closely related molecular species. Bispecific antibodies containing a protein A-binding-ablating substitution CH3 domain paired with a protein A-binding CH3 domain are separated with high peak resolution from monospecific antibodies containing a protein A-binding-ablating substituted CH3 domain paired with the protein A-binding-ablating substituted CH3 domain and monospecific antibodies containing a protein A-binding CH3 domain paired with the protein A-binding CH3 domain. Useful chaotropic agents include magnesium chloride and calcium chloride.

    Abstract translation: 使用离液剂和pH梯度或pH梯度洗脱缓冲液的高分辨率蛋白A色谱导致密切相关的分子种类之间的峰分辨率改善。 含有与蛋白质A结合CH3结构域配对的蛋白质A结合消融取代CH3结构域的双特异性抗体以高峰解析度从包含与蛋白质A结合消融取代CH3结构域配对的单特异性抗体的单特异性抗体分离, 消融取代的CH3结构域和含有蛋白A结合CH3结构域与蛋白A结合CH3结构域配对的单特异性抗体。 有用的离液剂包括氯化镁和氯化钙。

    CLARIFICATION OF MAMMALIAN CELL CULTURE
    10.
    发明申请
    CLARIFICATION OF MAMMALIAN CELL CULTURE 审中-公开
    马氏体细胞培养的澄清

    公开(公告)号:WO2015142777A1

    公开(公告)日:2015-09-24

    申请号:PCT/US2015/020862

    申请日:2015-03-17

    CPC classification number: C12P21/00 C12N5/0081

    Abstract: Disclosed is an improved method for clarifying a cell culture during the manufacture of a protein. The method includes the step of transiently reducing the pH of a cell culture, followed by a holding step for a period of time, followed by the neutralization of the cell culture prior to clarification by centrifugation.

    Abstract translation: 公开了一种在蛋白质制造过程中澄清细胞培养物的改进方法。 该方法包括将细胞培养物的pH瞬时降低,然后进行保持步骤一段时间,然后通过离心澄清澄清之前中和细胞培养物的步骤。

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