CN109125714B - 一种纯化治疗性蛋白质的方法 - Google Patents

一种纯化治疗性蛋白质的方法 Download PDF

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CN109125714B
CN109125714B CN201811091750.9A CN201811091750A CN109125714B CN 109125714 B CN109125714 B CN 109125714B CN 201811091750 A CN201811091750 A CN 201811091750A CN 109125714 B CN109125714 B CN 109125714B
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fibrinogen
solution
resin
vwf
total protein
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CN109125714A (zh
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H·法姆
J·M·黑
D·恩古
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CSL Behring GmbH Deutschland
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion
    • B01D15/361—Ion-exchange
    • B01D15/363—Anion-exchange
    • A—HUMAN NECESSITIES
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    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36—Blood coagulation or fibrinolysis factors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36—Blood coagulation or fibrinolysis factors
    • A61K38/363—Fibrinogen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36—Blood coagulation or fibrinolysis factors
    • A61K38/37—Factors VIII
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C07K1/18—Ion-exchange chromatography
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C07K1/20—Partition-, reverse-phase or hydrophobic interaction chromatography
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C07K1/22—Affinity chromatography or related techniques based upon selective absorption processes
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745—Blood coagulation or fibrinolysis factors
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745—Blood coagulation or fibrinolysis factors
    • C07K14/75—Fibrinogen
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745—Blood coagulation or fibrinolysis factors
    • C07K14/755—Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
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  • Gastroenterology & Hepatology (AREA)
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  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Materials For Medical Uses (AREA)
  • Enzymes And Modification Thereof (AREA)
CN201811091750.9A 2012-12-05 2013-12-05 一种纯化治疗性蛋白质的方法 Active CN109125714B (zh)

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US201261733761P 2012-12-05 2012-12-05
US61/733,761 2012-12-05
EP13153898.5 2013-02-04
EP13153898 2013-02-04
US13/803,740 US20140154233A1 (en) 2012-12-05 2013-03-14 Method of purifying therapeutic proteins
US13/803,740 2013-03-14
AU2013203357 2013-04-10
AU2013203357A AU2013203357B2 (en) 2012-12-05 2013-04-10 A method of purifying therapeutic proteins
PCT/AU2013/001414 WO2014085861A1 (en) 2012-12-05 2013-12-05 A method of purifying therapeutic proteins
CN201380063945.1A CN104981476B (zh) 2012-12-05 2013-12-05 一种纯化治疗性蛋白质的方法

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EP (2) EP2928905B1 (https=)
JP (3) JP6411360B2 (https=)
KR (2) KR102403847B1 (https=)
CN (2) CN109125714B (https=)
AU (2) AU2013203357B2 (https=)
BR (1) BR112015012854B1 (https=)
CA (2) CA2893373A1 (https=)
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MX351340B (es) 2012-03-13 2017-10-11 Octapharma Ag Proceso mejorado para la produccion de fibrinogeno y fibrinogeno producido por este.
US10188965B2 (en) 2012-12-05 2019-01-29 Csl Behring Gmbh Hydrophobic charge induction chromatographic depletion of a protein from a solution
US20140154233A1 (en) 2012-12-05 2014-06-05 Csl Limited Method of purifying therapeutic proteins
GB201506117D0 (en) 2015-04-10 2015-05-27 Ge Healthcare Bio Sciences Ab Method for chromatography
GB201506113D0 (en) 2015-04-10 2015-05-27 Ge Healthcare Bio Sciences Ab Method for chromatography
EP3400029B1 (en) * 2016-01-07 2022-03-02 Eio Biomedical Ltd Compositions for reducing tissue adhesions
KR20190026000A (ko) 2016-07-06 2019-03-12 라보라토이레 프란카이즈 듀 프락티온네먼트 에트 데스 바이오테크놀로지스 안정적 액체 피브리노겐
CN109789162A (zh) * 2016-09-01 2019-05-21 普拉斯富瑞有限公司 具有降低的纤溶活性的人类血液源产品及其在止血障碍中的用途
KR20250088663A (ko) * 2017-08-23 2025-06-17 체에스엘 베링 게엠베하 폰 빌레브란트 인자의 바이러스 여과 방법
IL317026A (en) * 2018-02-28 2025-01-01 Plas Free Ltd In vitro device and matrix for removing fibrinolytic proteins from biological fluids, methods and uses thereof
CN109078628B (zh) * 2018-08-27 2021-06-11 西北大学 一种以苄胺为配基的高效疏水相互作用色谱介质、制备方法及其在蛋白质复性与纯化的应用
FR3090321B1 (fr) 2018-12-21 2023-07-14 Lab Francais Du Fractionnement Procédé de filtration du fibrinogène
MX2023000156A (es) * 2020-06-24 2023-02-16 Bioverativ Therapeutics Inc Metodos para la eliminacion de factor viii libre de preparaciones de vectores lentivirales modificados para expresar dicha proteina.
JP2025512143A (ja) 2020-11-09 2025-04-17 武田薬品工業株式会社 酸化ケイ素吸着を使用する血漿からのｆｖｉｉｉの精製
WO2022218962A1 (en) 2021-04-13 2022-10-20 Grifols Worldwide Operations Limited Liquid composition comprising factor viii or factor viii/von willebrand factor complex
CN115181178B (zh) * 2021-09-04 2024-04-26 广东双林生物制药有限公司 一种从冷沉淀中制备人纤维蛋白原的方法
CN118401262A (zh) 2021-12-30 2024-07-26 巴克斯特国际公司 用于纤维蛋白密封剂的纤维蛋白原和凝血酶溶液以及纤维蛋白密封剂试剂盒

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KR20210042422A (ko) 2021-04-19
JP2021073280A (ja) 2021-05-13
RU2685956C2 (ru) 2019-04-23
US20190209948A1 (en) 2019-07-11
CN104981476B (zh) 2018-10-09
AU2013354899A1 (en) 2015-07-16
US20170143805A1 (en) 2017-05-25
BR112015012854A2 (pt) 2017-07-11
JP2019011346A (ja) 2019-01-24
EP2928905B1 (en) 2018-11-21
PL2928905T3 (pl) 2019-05-31
US20210283530A1 (en) 2021-09-16
KR20150090252A (ko) 2015-08-05
KR102240978B1 (ko) 2021-04-19
AU2013203357A1 (en) 2014-06-19
JP2016501878A (ja) 2016-01-21
SG11201504372UA (en) 2015-07-30
AU2013354899B2 (en) 2018-05-17
AU2013203357B2 (en) 2015-08-27
EP2928905A1 (en) 2015-10-14
BR112015012854B1 (pt) 2021-11-30
US20150158906A1 (en) 2015-06-11
CN109125714A (zh) 2019-01-04
HK1214833A1 (en) 2016-08-05
WO2014085861A1 (en) 2014-06-12
SG10201704484QA (en) 2017-07-28
RU2015126551A (ru) 2017-01-10
JP6411360B2 (ja) 2018-10-24
CN104981476A (zh) 2015-10-14
KR102403847B1 (ko) 2022-05-31
CA3185085A1 (en) 2014-06-12
US9598461B2 (en) 2017-03-21
JP7774384B2 (ja) 2025-11-21
EP2928905A4 (en) 2016-06-08
US11426680B2 (en) 2022-08-30
CA2893373A1 (en) 2014-06-12
US20140154233A1 (en) 2014-06-05
JP6836562B2 (ja) 2021-03-03
EP3483173A1 (en) 2019-05-15

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