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    Method of Storing a Separation Matrix
    2.
    发明申请
    Method of Storing a Separation Matrix 审中-公开

    公开(公告)号：US20200239517A1

    公开(公告)日：2020-07-30

    申请号：US16095721

    申请日：2017-05-10

    Applicant: GE HEALTHCARE BIOPROCESS R&D AB

    Inventor： Annika Forss ,  Gustav José Rodrigo ,  Tomas Bjorkman ,  Mats Ander ,  Jesper Ulf Hansson

    IPC: C07K1/22 ,  C07K16/06 ,  B01D15/00 ,  B01J20/32 ,  C07K17/10 ,  C07K16/12 ,  C07K14/31 ,  B01J20/286

    Abstract: The present invention concerns a method of storing 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) providing a storage liquid comprising at least 50% by volume of an aqueous alkali metal hydroxide solution; b) permeating the separation matrix with the storage liquid; and c) storing the storage liquid-permeated separation matrix for a storage time of at least days. The alkali-stabilized Protein A domains comprise mutants of a parental Fc-binding domain of Staphylococcus Protein A (SpA), as defined by, or having at least 80% such as at least 90%, 95% or 98% identity to, 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.

    Method of Cleaning and/or Sanitizing a Separation Matrix
    7.
    发明申请
    Method of Cleaning and/or Sanitizing a Separation Matrix 审中-公开

    公开(公告)号：US20200299325A1

    公开(公告)日：2020-09-24

    申请号：US16095753

    申请日：2017-05-10

    Applicant: GE HEALTHCARE BIOPROCESS R&D AB

    Inventor： Annika Forss ,  Gustav José Rodrigo ,  Tomas Bjorkman ,  Mats Ander ,  Jesper Ulf Hansson

    IPC: C07K1/22 ,  C07K16/00 ,  C07K14/31 ,  B01J20/32 ,  B01J20/26 ,  B01J20/285 ,  B01J20/286 ,  C07K16/12 ,  C07K17/10

    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.

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