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公开(公告)号：US11667671B2
公开(公告)日：2023-06-06
申请号：US16911511
申请日：2020-06-25
发明人： Annika Forss , Mats Ander , Tomas Bjorkman , Hans Blom , Jesper Hansson , Gustav Rodrigo
IPC分类号： C07K1/16 , C07K1/22 , C07K16/00 , B01J20/286 , B01J20/285 , B01D15/18 , B01D15/34 , C07K14/31
CPC分类号： C07K1/165 , B01D15/1807 , B01D15/1864 , B01D15/34 , B01J20/285 , B01J20/286 , C07K1/22 , C07K14/31 , C07K16/00 , C07K2317/21 , C07K2317/31 , C07K2319/30
摘要： 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.-
公开(公告)号：US20240018184A1
公开(公告)日：2024-01-18
申请号：US18354413
申请日：2023-07-18
IPC分类号： C07K1/22 , B01J20/26 , B01J20/285 , B01J20/286 , B01J20/32 , C07K14/31 , C07K16/00 , C07K16/12 , C07K17/10
CPC分类号： C07K1/22 , B01J20/267 , B01J20/285 , B01J20/286 , B01J2220/52 , C07K14/31 , C07K16/00 , C07K16/1271 , C07K17/10 , B01J20/3274
摘要： 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.-
公开(公告)号：US11708390B2
公开(公告)日：2023-07-25
申请号：US16095721
申请日：2017-05-10
IPC分类号： C07K1/22 , B01D15/00 , C07K14/31 , B01J20/286 , B01J20/32 , C07K16/06 , C07K16/12 , C07K17/10
CPC分类号： C07K1/22 , B01D15/00 , B01J20/286 , B01J20/3212 , B01J20/3274 , C07K14/31 , C07K16/065 , C07K16/1271 , C07K17/10 , B01J2220/52
摘要： 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.
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公开(公告)号：US11753438B2
公开(公告)日：2023-09-12
申请号：US16095753
申请日：2017-05-10
IPC分类号： C07K1/22 , B01J20/26 , B01J20/285 , B01J20/286 , B01J20/32 , C07K14/31 , C07K16/00 , C07K16/12 , C07K17/10
CPC分类号： C07K1/22 , B01J20/267 , B01J20/285 , B01J20/286 , B01J20/3274 , C07K14/31 , C07K16/00 , C07K16/1271 , C07K17/10 , B01J2220/52
摘要： 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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