Method for Endotoxin Removal
    74.
    发明申请
    Method for Endotoxin Removal 审中-公开
    内毒素去除方法

    公开(公告)号:US20170067031A1

    公开(公告)日:2017-03-09

    申请号:US15355675

    申请日:2016-11-18

    CPC classification number: C12N7/00 B01D15/3847 C12N2760/16151

    Abstract: The present invention relates to a method for endotoxin removal from a sample comprising the following steps: combining the sample comprising one or more target molecule(s) with a chromatography media comprising beads having an inner porous core functionalized with ligands capable of binding endotoxin and an outer porous layer without functional groups and a pore size small enough to exclude the target molecule from the inner core; and collecting the sample from the media, wherein the sample comprises an endotoxin level which is at least 75% less, preferably 90% less, than before the removal and the yield of the target molecule is at least 75%.

    Abstract translation: 本发明涉及一种从样品中去除内毒素的方法,包括以下步骤:将包含一种或多种靶分子的样品与包含珠的色谱介质组合,所述珠粒具有由能够结合内毒素的配体功能化的内部多孔核心和 没有官能团的外部多孔层和足够小以从靶芯排出靶分子的孔径; 并从培养基中收集样品,其中样品包含与去除前相比至少75%以上,优选90%以下的内毒素水平,并且目标分子的产率为至少75%。

    Method of Cleaning and/or Sanitizing a Separation Matrix

    公开(公告)号:US20200299325A1

    公开(公告)日:2020-09-24

    申请号:US16095753

    申请日:2017-05-10

    Abstract: The present invention concerns a method of cleaning and/or sanitizing a separation matrix comprising multimers of immunoglobulin-binding alkali-stabilized Protein A domains covalently coupled to a porous support. The method comprises the steps of: a) optionally purifying a mixture comprising a first immunoglobulin using the separation matrix; b) providing a cleaning liquid comprising at least 50% by volume of an aqueous alkali metal hydroxide solution; and c) cleaning and/or sanitizing the separation matrix by contacting the cleaning liquid with the separation matrix for a predetermined contact time. The alkali-stabilized Protein A domains comprise mutants of a parental Fc-binding domain of Staphylococcus Protein A (SpA), as defined by SEQ ID NO 51 or SEQ ID NO 52, wherein the amino acid residues at positions 13 and 44 of SEQ ID NO 51 or 52 are asparagines and wherein at least the asparagine residue at position 3 of SEQ ID NO 51 or 52 has been mutated to an amino acid selected from the group consisting of glutamic acid, lysine, tyrosine, threonine, phenylalanine, leucine, isoleucine, tryptophan, methionine, valine, alanine, histidine and arginine.

    Separation method
    78.
    发明授权

    公开(公告)号:US10730908B2

    公开(公告)日:2020-08-04

    申请号:US15798784

    申请日:2017-10-31

    Abstract: The invention relates to a method of isolating an immunoglobulin, comprising the steps of: a) providing a separation matrix comprising at least 15 mg/ml multimers of immunoglobulin-binding alkali-stabilized Protein A domains covalently coupled to a porous support, wherein the porous support comprises cross-linked polymer particles having a volume-weighted median diameter (d50,v) of 56-70 micrometers and a dry solids weight of 55-80 mg/ml; b) contacting a liquid sample comprising an immunoglobulin with the separation matrix; c) washing the separation matrix with a washing liquid; d) eluting the immunoglobulin from the separation matrix with an elution liquid; and e) cleaning the separation matrix with a cleaning liquid comprising at least 0.5 M NaOH.

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