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公开(公告)号:US20240391984A1
公开(公告)日:2024-11-28
申请号:US18682409
申请日:2022-08-24
Applicant: Cytiva Bioprocess R&D AB
Inventor: Mats Ander , Joakim Galli , Andreas L. Jonsson , Gustav Rodrigo
Abstract: The present relates to a polypeptide that binds to an immunoglobulin or a fragment thereof. More specifically, it relates to a kappa light-chain binding polypeptide with high binding affinity and improved alkali stability. The one kappa light-chain binding comprises a mutated binding domain of Peptostreptococcus Protein L, derived from any one of the amino acid sequences SEQ ID NO:10, SEQ ID NO:11, SEQ ID NO:12, SEQ ID NO:13, SEQ ID NO:14, SEQ ID NO:15, SEQ ID NO:16, SEQ ID NO:17 or SEQ ID NO:18, said amino acid sequences having N6H, N41H and N56Y or N56Q mutations.
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公开(公告)号:US12134633B2
公开(公告)日:2024-11-05
申请号:US18298857
申请日:2023-04-11
Applicant: Cytiva BioProcess R&D AB
Inventor: Gustav José Rodrigo , Tomas Bjorkman , Mats Ander , Jesper Ulf Hansson
IPC: C07K1/22 , B01D15/38 , B01J20/24 , B01J20/28 , B01J20/286 , B01J20/32 , C07K14/31 , C07K16/00 , C07K16/06 , C07K17/10
Abstract: The invention relates to a separation matrix comprising at least 11 mg/ml Fc-binding ligands covalently coupled to a porous support, wherein: a) the ligands comprise multimers of alkali-stabilized Protein A domains, and b) 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.
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公开(公告)号:US12044663B2
公开(公告)日:2024-07-23
申请号:US16067628
申请日:2017-01-06
Applicant: Cytiva BioProcess R&D AB
Inventor: Klaus Gebauer , Dan Hermansson
CPC classification number: G01N30/6004 , B01D15/206 , B01D15/22 , G01N30/56 , G01N2030/565 , G01N30/6021 , G01N30/606
Abstract: A method for packing a chromatography column with chromatography media, comprising the steps of: providing a system comprising a column tube (3,19,21) having a closed first end (5) comprising an inlet/outlet (7), a media inlet (15) adjacent a second end of the column tube and an adaptor (9) positioned inside the column tube initially adjacent the second end of the column tube for sliding and sealing contact with an inner face of the column tube, the column tube and adaptor arranged initially such that they define an internal volume and such that the media inlet is in fluid connection with the internal volume; connecting a media slurry source to the media inlet; at least partially filling the internal volume with media slurry via the media inlet; forcing the adaptor towards the first end of the column tube to reduce the internal volume such that the media inlet is no longer in fluid connection with the reduced internal volume.
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公开(公告)号:US20240228530A1
公开(公告)日:2024-07-11
申请号:US18562092
申请日:2022-06-22
Applicant: Cytiva BioProcess R&D AB
Inventor: Bengt Westerlund , Mats Ander
IPC: C07K1/22
CPC classification number: C07K1/22 , C07K2317/31 , C07K2317/56
Abstract: The present invention relates to a method of separating bispecific antibodies or bispecific antibody fragments. The method comprises the steps of a) providing a feed comprising bispecific antibodies or bispecific antibody fragments; b) contacting the feed with a separation matrix having affinity ligands coupled to a support; c) optionally washing the separation resin with a washing liquid; d) applying an elution buffer to the separation resin, to elute the antibodies or antibody fragments bound to the affinity ligand; wherein in step d) a pH gradient is applied over the elution buffer, said pH gradient being from about 6 to about 2.
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公开(公告)号:US20240018184A1
公开(公告)日:2024-01-18
申请号:US18354413
申请日:2023-07-18
Applicant: CYTIVA BIOPROCESS R&D AB
Inventor: Annika Forss , Gustav José Rodrigo , Tomas Bjorkman , Mats Ander , Jesper Ulf Hansson
IPC: C07K1/22 , B01J20/26 , B01J20/285 , B01J20/286 , B01J20/32 , C07K14/31 , C07K16/00 , C07K16/12 , C07K17/10
CPC classification number: C07K1/22 , B01J20/267 , B01J20/285 , B01J20/286 , B01J2220/52 , C07K14/31 , C07K16/00 , C07K16/1271 , C07K17/10 , B01J20/3274
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.-
公开(公告)号:US11708390B2
公开(公告)日:2023-07-25
申请号:US16095721
申请日:2017-05-10
Applicant: Cytiva BioProcess R&D AB
Inventor: Annika Forss , Gustav José Rodrigo , Tomas Bjorkman , Mats Ander , Jesper Ulf Hansson
CPC classification number: C07K1/22 , B01D15/00 , B01J20/286 , B01J20/3212 , B01J20/3274 , C07K14/31 , C07K16/065 , C07K16/1271 , C07K17/10 , B01J2220/52
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.
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公开(公告)号:US20230094241A1
公开(公告)日:2023-03-30
申请号:US18056581
申请日:2022-11-17
Applicant: Cytiva BioProcess R&D AB
Inventor: Klaus Gebauer , Manoj Kumar Ramakrishna , Daniel Salomonsson , Per Lofving
Abstract: A parallel assembly of chromatography column modules connected in a rigid housing the assembly having one common assembly inlet and one common assembly outlet each column module comprising a bed space filled with chromatography medium and each column module comprises integrated fluid conduits which when the column module is connected with other column modules in the rigid housing are adapted to connect the bed space of the column module with the assembly inlet and the assembly outlet wherein the total length and/or volume of the fluid conduit from the assembly inlet to one bed space together with the length and/or volume of the fluid conduit from the same bed space to the assembly outlet is substantially the same for all bed spaces and modules installed in the parallel assembly.
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公开(公告)号:US11529570B2
公开(公告)日:2022-12-20
申请号:US17102801
申请日:2020-11-24
Applicant: Cytiva BioProcess R&D AB
Inventor: Klaus Gebauer , Manoj Kumar Ramakrishna , Daniel Salomonsson , Per Lofving
Abstract: A parallel assembly (2; 11; 51) of chromatography column modules (3a,b,c; 13a,b,c; 53a,b,c, 90a, b) connected in a rigid housing (21; 61), the assembly having one common assembly inlet (15; 55) and one common assembly outlet (17; 57), each column module comprising a bed space (29) filled with chromatography medium and each column module comprises integrated fluid conduits which when the column module is connected with other column modules in the rigid housing are adapted to connect the bed space (29) of the column module with the assembly inlet (15; 55) and the assembly outlet (17; 57), wherein the total length and/or volume of the fluid conduit from the assembly inlet to one bed space together with the length and/or volume of the fluid conduit from the same bed space to the assembly outlet is substantially the same for all bed spaces and modules installed in the parallel assembly.
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公开(公告)号:US20220315647A1
公开(公告)日:2022-10-06
申请号:US17604964
申请日:2020-04-29
Applicant: Cytiva Bioprocess R&D AB
Inventor: Gustav Rodrigo , Mats Ander , Tomas Bjorkman , Ronnie Palmgren , Charlotte Brink
Abstract: The invention discloses a method for separation of antibodies or antibody fragments, comprising the steps of: a) providing a feed comprising antibodies or antibody fragments having a VH3 region and being devoid of an Fc region capable of binding to Protein A; b) contacting the feed with a separation resin having covalently coupled ligands, wherein the ligands comprise a polypeptide as defined by SEQ ID NO 1 and wherein the antibodies or antibody fragments bind to the separation resin; c) optionally washing the separation resin with a washing liquid; d) eluting the antibodies or antibody fragments from the separation resin with an elution liquid and recovering the antibodies or antibody fragments.
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公开(公告)号:US11439926B2
公开(公告)日:2022-09-13
申请号:US16701942
申请日:2019-12-03
Applicant: Cytiva BioProcess R&D AB
Inventor: Jan Bergstrom , Gunnar Glad , Bo-Lennart Johansson , Jean-Luc Maloisel , Nils Norrman , Tobias E. Soderman
IPC: C07K1/20 , B01D15/32 , B01J20/285 , B01J20/287 , B01J39/26 , B01J20/28 , B01J20/32 , C07K16/00 , C12N7/00 , G01N1/40
Abstract: The present invention is within the field of chromatography. More precisely, it relates to a novel chromatography medium, namely a hydrophobic medium provided with different lids excluding molecules over a certain size due to the porosity of the hydrophobic medium and/or the porosity of the lid. The invention also relates to use of the separation medium for purification of large molecules, which do not enter the separation medium, as well as small molecules, which enter the separation medium and are eluted from there.
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