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：US20190201812A1

公开(公告)日：2019-07-04

申请号：US16311750

申请日：2017-06-20

Applicant: CLEMSON UNIVERSITY

Inventor： R. Kenneth MARCUS ,  LIUWEI JIANG

IPC: B01D15/20 ,  B01J20/26 ,  B01J20/286 ,  B01J20/32 ,  B01J20/30 ,  B01J20/28

CPC classification number: B01D15/20 ,  B01D15/22 ,  B01D15/305 ,  B01D15/361 ,  B01D15/3804 ,  B01D63/02 ,  B01D67/0093 ,  B01D69/082 ,  B01D71/56 ,  B01D2323/38 ,  B01J20/264 ,  B01J20/28023 ,  B01J20/286 ,  B01J20/3078 ,  B01J20/3212 ,  B01J20/3278 ,  B01J20/328 ,  B01J39/26 ,  B01J41/20 ,  B01J47/127 ,  B01J2220/58 ,  G01N33/68

Abstract: Chromatography devices and methods for forming and using the devices are described. The devices include a polyimide-based support phase and a polymer grafted to a surface of the polyimide-based support phase. A microwave-assisted graft polymerization protocol is described to form the polymer at the surface of the support phase. Devices can be utilized in high-efficiency separation of macromolecules such as proteins.

公开(公告)号：US20190194258A1

公开(公告)日：2019-06-27

申请号：US16228802

申请日：2018-12-21

Applicant: ZHAOKE (GUANGZHOU) OPHTHALMIC DRUG COMPANY LIMITED

Inventor： Gang Li ,  Kailei Cao ,  Xiaoyi Li ,  Xiangrong Dai ,  Lei Yin ,  Juan Ling

IPC: C07K7/64 ,  C07K1/16 ,  B01D15/16 ,  B01D15/18 ,  B01D15/42 ,  B01J20/10

CPC classification number: C07K7/645 ,  B01D15/161 ,  B01D15/163 ,  B01D15/18 ,  B01D15/426 ,  B01J20/103 ,  B01J20/286 ,  B01J20/291 ,  B01J2220/58 ,  C07K1/16 ,  G01N30/30 ,  G01N30/88 ,  G01N2030/342 ,  G01N2030/8872

Abstract: A method of controlling the impurities in a cyclosporin A eye gel. A high performance liquid chromatography is performed, and chromatographic conditions are as follows: the detection wavelength is 210-230 nm; the column temperature is 60-68° C.; the flow rate is 0.8-1 ml/min; and the mobile phase A is: THF-water-phosphoric acid. The method of controlling impurities solves the problem of excipients interference and separation of many impurities at the same time, it also provides an effective method for the formulation of quality standard of impurities in this kind of preparation.

公开(公告)号：US20180264435A1

公开(公告)日：2018-09-20

申请号：US15544434

申请日：2016-01-19

Applicant: Hitachi Chemical Company, LTD.

Inventor： Masaru WATANABE ,  Yasushi GOTOH ,  Michio BUTSUGAN ,  Ryoichi NAKANISHI

IPC: B01J20/24 ,  B01D15/08 ,  B01J20/28

CPC classification number: B01J20/24 ,  B01D15/08 ,  B01J20/28 ,  B01J20/28047 ,  B01J20/28057 ,  B01J20/28097 ,  B01J20/286 ,  B01J20/321 ,  B01J20/3274 ,  B01J20/3282 ,  C07K1/16 ,  G01N30/88

Abstract: The present invention provides a separation material including porous polymer particles that comprise at least one of styrene and divinylbenzene as a monomer unit at a proportion of 90% by mass or more based on the total amount of the monomers; and a coating layer that comprises a macromolecule having hydroxyl groups and covers at least a portion of the surface of the porous polymer particles, wherein the coating amount provided by the coating layer is 1 to 15 mg/m2 per unit specific surface area of the porous polymer particles.

公开(公告)号：US20180244729A1

公开(公告)日：2018-08-30

申请号：US15900419

申请日：2018-02-20

Applicant: GE Healthcare BioProcess R&D AB

Inventor： Gustav Rodrigo ,  Mats Ander ,  Tomas BJORKMAN ,  Goran Bauren

IPC: C07K14/31 ,  B01D15/38 ,  C07K14/745 ,  C07K1/22 ,  C07K16/00 ,  B01J20/32 ,  B01J20/286

CPC classification number: C07K14/31 ,  B01D15/3809 ,  B01J20/286 ,  B01J20/3204 ,  B01J20/3212 ,  B01J20/3219 ,  B01J20/3274 ,  C07K1/22 ,  C07K14/745 ,  C07K16/00

Abstract: The invention discloses a polypeptide with improved alkaline stability, which polypeptide comprises a mutant of a B or C domain of Staphylococcus Protein A (SpA), as specified by SEQ ID NO 1 or SEQ ID NO 2, or of Protein Z, as specified by SEQ ID NO 3, wherein at least the glutamine residue at position 9 has been mutated to an amino acid other than asparagine. The invention also discloses multimers of said polypeptide, as well as separation matrices comprising the multimers or polypeptides.

公开(公告)号：US20180224438A1

公开(公告)日：2018-08-09

申请号：US15751125

申请日：2016-08-09

Applicant: ARIZONA BOARD OF REGENTS ON BEHALF OF THE UNIVERSITY OF ARIZONA

Inventor： Craig A. Aspinwall ,  Jinyan Wang ,  Kendall Sandy ,  Steven Scott Saavedra ,  Christopher Baker ,  Elyssia S. Gallagher

IPC: G01N33/543 ,  G01N33/545 ,  G01N33/531 ,  B01L7/00 ,  B01L3/00

CPC classification number: G01N33/5432 ,  B01J20/286 ,  B01J20/3204 ,  B01J20/3272 ,  B01J20/3287 ,  B01J2220/84 ,  B01J2220/86 ,  B01L3/5082 ,  B01L7/00 ,  B01L2300/0832 ,  B01L2300/18 ,  B01L2300/1805 ,  C07K14/705 ,  C07K17/14 ,  G01N33/531 ,  G01N33/54353 ,  G01N33/545

Abstract: Surface-modified silica microparticles that are functionalized with stabilized phospholipid vesicles are described herein. These stabilized vesicles can be functionalized with either transmembrane receptors or membrane associated receptors and used for affinity pull-down assays or other chromatographic separation modalities to provide affinity capture/concentration of low abundance ligands in complex mixtures with minimal sample preparation. Further described are methods and apparatus for forming polymer frits in a fused silica capillary. The capillary containing a monomer solution is placed between one or more heat sources connected to each other via a jig and operatively coupled to a temperature controller. The polymer frits are synthesized via thermal polymerization of the monomer solution using the heat sources, which allows for placement of the polymer frits at a spatially-defined location in the capillary.

公开(公告)号：US20180215796A1

公开(公告)日：2018-08-02

申请号：US15876610

申请日：2018-01-22

Applicant: Kaneka Corporation

Inventor： Masakatsu Nishihachijyo ,  Yoshiyuki Nakano ,  Fuminori Konoike ,  Masayuki Takano ,  Shinichi Yoshida ,  Kazunobu Minakuchi

IPC: C07K14/31 ,  C07K1/22

CPC classification number: C07K14/31 ,  B01D15/3809 ,  B01J20/286 ,  B01J20/3274 ,  C07K1/22 ,  C07K17/00 ,  C07K2319/30

Abstract: A protein includes an amino acid sequence derived from a sequence selected from the group consisting of SEQ ID NOs: 1 to 5. The amino acid sequence includes a substitution of a hydrophobic amino acid residue, an acidic amino acid residue, or a polar uncharged amino acid residue with a basic amino acid residue, and the protein has a reduced antibody-binding capacity in an acidic pH range, as compared to a protein including the amino acid sequence without the substitution.