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.

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：US11808670B2

公开(公告)日：2023-11-07

申请号：US16081984

申请日：2017-03-03

Applicant: TANAKA KIKINZOKU KOGYO K.K.

Inventor： Keita Suzuki ,  Yuya Kato ,  Hisahiko Iwamoto

IPC: G01N33/569 ,  G01N33/543 ,  B01J20/286 ,  G01N30/02 ,  B01J20/292

CPC classification number: G01N33/56944 ,  B01J20/286 ,  G01N33/543 ,  B01J20/292 ,  G01N2030/027

Abstract: The invention relates to an immunochromatographic device which contains a nitrous acid compound and an organic acid or an organic acid derivative and which is for detecting a detection target in an analyte wherein a sample droplet-receiving member, a labeling substance-holding member, a chromatography medium member and an absorption member are arranged in a manner that a sample develops in this order and wherein a part containing the nitrous acid compound and a part containing the organic acid or the like are at upstream positions from the labeling substance-containing part, and the part containing the nitrous acid compound and the part containing the organic acid or the like are not substantially in contact with each other in the thickness direction.

公开(公告)号：US20230348368A1

公开(公告)日：2023-11-02

申请号：US18338435

申请日：2023-06-21

Applicant: ITALFARMACO SPA

Inventor： Stefano TURCHETTA ,  Maurio ZENONI ,  Elio ULLUCCI ,  Stefania COCCIOLO ,  Giorgio Berardi ,  Nakia MAULUCCI

IPC: C07C271/28 ,  C07C269/06 ,  B01J20/286 ,  C07C269/08

CPC classification number: C07C271/28 ,  C07C269/06 ,  B01J20/286 ,  C07C269/08 ,  G01N2030/027

Abstract: A process for obtaining {{6-[(diethylamino)methyl]naphthalen-2-yl}methyl [4-(hydroxycarbamoyl)phenyl]carbamate and/or pharmaceutically acceptable salts thereof having high purity is described. This process allows to obtain a product having an amount of any single unknown impurity equal to or less than 0.10%, as well as a product having a purity greater than 99.5%, preferably equal to or greater than 99.6%.
An HPLC method for determining the purity of the product and possible impurities thereof is also described.

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

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

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.

公开(公告)号：US11596876B2

公开(公告)日：2023-03-07

申请号：US16267579

申请日：2019-02-05

Applicant: CLEMSON UNIVERSITY RESEARCH FOUNDATION

Inventor： R. Kenneth Marcus ,  Terri F. Bruce ,  Lei Wang ,  Sisi Huang ,  Tyler Y. Slonecki ,  Rhonda Reigers Powell

IPC: B01D15/32 ,  G01N30/00 ,  C07K14/47 ,  C12N9/00 ,  C12N15/10 ,  G01N1/40 ,  G01N33/50 ,  A61K35/68 ,  B01J20/26 ,  B01J20/28 ,  B01J20/285 ,  B01J20/286

Abstract: A relatively fast, inexpensive, and non-destructive method for separation and isolation of biologically active nanoparticles is described. Methods include the use of solid phase separation medis such as channeled fibers in a hydrophobic interaction chromatography (HIC) protocol to isolate biologically active nanoparticles from other components of a mixture. Biologically active nanoparticles can include natural nanoparticles (e.g., exosomes, lysosomes, virus particles) as well as synthetic nanoparticles (liposomes, genetically modified virus particles, etc.)

公开(公告)号：US20230060770A1

公开(公告)日：2023-03-02

申请号：US17821120

申请日：2022-08-19

Applicant: Cephalon LLC

Inventor： Lu WANG ,  Albert KAO ,  Zhaoqing ZHANG ,  Mi JIN ,  Tianyi ZHOU

IPC: B01J20/286 ,  C07K1/22 ,  C07K16/18 ,  B01D15/36 ,  B01J20/28 ,  C12Q1/686 ,  C07K1/18 ,  C07K16/00 ,  C07K16/28

Abstract: A wash buffer comprising a surfactant for use in affinity and cation exchange chromatography to purify proteins of interest from protein aggregates and to remove and/or inactivate viruses. When used during affinity or cation exchange chromatography for the purification of a protein of interest, such as an antibody, the wash buffer significantly improves viral clearance from the preparation, while also reducing the levels of host cell proteins and protein aggregates. Following affinity or cation exchange chromatography with the wash buffer, the protein of interest may be further purified using other chromatography and filtration operations.

公开(公告)号：US20220339628A1

公开(公告)日：2022-10-27

申请号：US17753707

申请日：2020-09-07

Applicant: COMMISSARIAT À L'ÉNERGIE ATOMIQUE ET AUX ÉNERGIES ALTERNATIVES ,  CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE ,  UNIVERSITE PARIS-SACLAY

Inventor： Carole Bresson ,  Marta Garcia-Cortes ,  Claude Vidaud ,  Thuy Tran

IPC: B01L3/00 ,  B01J20/28 ,  B01J20/286 ,  B01J20/32 ,  C07K1/04 ,  C01G43/025

Abstract: A method for preparing, in the internal volume of at least one channel, a monolithic support on which uranyl cations are immobilised. The method comprises: (a) activating the inner surface of the channel(s); (b) introducing, into the internal volume of the channel(s), a polymerisation solution comprising: a monomer comprising a phosphate group, at least one crosslinking agent, several solvents, and a radical polymerisation initiator; (c) polymerising the polymerisation solution; (d) rinsing the monolithic support obtained in step (c); and (e) contacting the monolithic support previously rinsed, with a solution comprising uranyl cations. A method for capturing proteins that selectively bind uranium by means of a monolithic support prepared by the above-mentioned method, as well as to a method for recovering proteins that selectively bind uranium with the capture method.

公开(公告)号：US11426706B2

公开(公告)日：2022-08-30

申请号：US16014778

申请日：2018-06-21

Applicant: Cephalon, Inc.

Inventor： Lu Wang ,  Albert Kao ,  Zhaoqing Zhang ,  Mi Jin ,  Tianyi Zhou

IPC: B01D15/36 ,  C07K1/18 ,  B01J20/286 ,  B01J20/28 ,  C07K1/22 ,  C07K16/18 ,  C12Q1/686 ,  C07K16/00 ,  C07K16/28

Abstract: A wash buffer comprising a surfactant for use in affinity and cation exchange chromatography to purify proteins of interest from protein aggregates and to remove and/or inactivate viruses. When used during affinity or cation exchange chromatography for the purification of a protein of interest, such as an antibody, the wash buffer significantly improves viral clearance from the preparation, while also reducing the levels of host cell proteins and protein aggregates. Following affinity or cation exchange chromatography with the wash buffer, the protein of interest may be further purified using other chromatography and filtration operations.

公开(公告)号：US20220034852A1

公开(公告)日：2022-02-03

申请号：US17370589

申请日：2021-07-08

Applicant: Waters Technologies Corporation

Inventor： Matthew A. Lauber ,  Stephan M. Koza ,  Pamela C. Iraneta ,  Kevin D. Wyndham

IPC: G01N30/06 ,  G01N30/72 ,  C08F230/08 ,  B01D15/30 ,  C08L33/14 ,  C08F220/54 ,  C08F220/56 ,  B01J20/28 ,  B01J20/32 ,  C08F222/38 ,  B01J20/286

Abstract: The invention relates to poly-amide bonded hydrophilic interaction chromatography (HILIC) stationary phases and novel HILIC methods for use in the characterization of large biological molecules modified with polar groups, known to those skilled in the art as glycans. The invention particularly provides novel, poly-amide bonded materials designed for efficient separation of large biomolecules, e.g. materials having a large percentage of larger pores (i.e. wide pores). Furthermore, the invention advantageously provides novel HILIC methods that can be used in combination with the stationary phase materials described herein to effectively separate protein and peptide glycoforms by eliminating previously unsolved problems, such as on-column aggregation of protein samples, low sensitivity of chromatographic detection of the glycan moieties, and low resolution of peaks due to restricted pore diffusion and long intra/inter-particle diffusion distances.