AU2013203357B2 - A method of purifying therapeutic proteins - Google Patents

A method of purifying therapeutic proteins Download PDF

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Publication number
AU2013203357B2
AU2013203357B2 AU2013203357A AU2013203357A AU2013203357B2 AU 2013203357 B2 AU2013203357 B2 AU 2013203357B2 AU 2013203357 A AU2013203357 A AU 2013203357A AU 2013203357 A AU2013203357 A AU 2013203357A AU 2013203357 B2 AU2013203357 B2 AU 2013203357B2
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AU
Australia
Prior art keywords
fibrinogen
solution
vwf
factor viii
resin
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
AU2013203357A
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English (en)
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AU2013203357A1 (en
Inventor
Jeffrey Michael Hey
Darren Nguy
Hung Pham
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CSL Behring GmbH Deutschland
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CSL Behring GmbH Deutschland
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by CSL Behring GmbH Deutschland filed Critical CSL Behring GmbH Deutschland
Priority to PCT/AU2013/001414 priority Critical patent/WO2014085861A1/en
Priority to BR112015012854-8A priority patent/BR112015012854B1/pt
Priority to HK16102793.7A priority patent/HK1214833B/en
Priority to SG11201504372UA priority patent/SG11201504372UA/en
Priority to EP18207150.6A priority patent/EP3483173A1/en
Priority to AU2013354899A priority patent/AU2013354899B2/en
Priority to SG10201704484QA priority patent/SG10201704484QA/en
Priority to EP13861334.4A priority patent/EP2928905B1/en
Priority to SG10201911709RA priority patent/SG10201911709RA/en
Priority to CA3185085A priority patent/CA3185085A1/en
Priority to CA2893373A priority patent/CA2893373A1/en
Priority to PL13861334T priority patent/PL2928905T3/pl
Priority to ES13861334T priority patent/ES2711455T3/es
Priority to JP2015545601A priority patent/JP6411360B2/ja
Priority to CN201811091750.9A priority patent/CN109125714B/zh
Priority to CN201380063945.1A priority patent/CN104981476B/zh
Priority to KR1020217010484A priority patent/KR102403847B1/ko
Priority to KR1020157017824A priority patent/KR102240978B1/ko
Priority to TR2019/02450T priority patent/TR201902450T4/tr
Priority to DK13861334.4T priority patent/DK2928905T3/en
Priority to US14/649,374 priority patent/US10188965B2/en
Priority to RU2015126551A priority patent/RU2685956C2/ru
Publication of AU2013203357A1 publication Critical patent/AU2013203357A1/en
Priority to US14/535,085 priority patent/US9598461B2/en
Assigned to CSL BEHRING GMBH reassignment CSL BEHRING GMBH Request for Assignment Assignors: CSL LIMITED
Application granted granted Critical
Publication of AU2013203357B2 publication Critical patent/AU2013203357B2/en
Priority to JP2018178301A priority patent/JP6836562B2/ja
Priority to US16/214,519 priority patent/US11426680B2/en
Priority to JP2021016182A priority patent/JP7774384B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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

Landscapes

  • 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)
  • Genetics & Genomics (AREA)
  • Hematology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Analytical Chemistry (AREA)
  • Toxicology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • 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)
AU2013203357A 2012-12-05 2013-04-10 A method of purifying therapeutic proteins Active AU2013203357B2 (en)

Priority Applications (26)

Application Number Priority Date Filing Date Title
CN201811091750.9A CN109125714B (zh) 2012-12-05 2013-12-05 一种纯化治疗性蛋白质的方法
HK16102793.7A HK1214833B (en) 2012-12-05 2013-12-05 A method of purifying therapeutic proteins
SG11201504372UA SG11201504372UA (en) 2012-12-05 2013-12-05 A method of purifying therapeutic proteins
EP18207150.6A EP3483173A1 (en) 2012-12-05 2013-12-05 Separation of fibrinogen, fviii and/or vwf from plasma proteases by hcic
AU2013354899A AU2013354899B2 (en) 2012-12-05 2013-12-05 A method of purifying therapeutic proteins
SG10201704484QA SG10201704484QA (en) 2012-12-05 2013-12-05 A method of purifying therapeutic proteins
EP13861334.4A EP2928905B1 (en) 2012-12-05 2013-12-05 A method of purifying therapeutic proteins
KR1020217010484A KR102403847B1 (ko) 2012-12-05 2013-12-05 치료학적 단백질의 정제 방법
CA3185085A CA3185085A1 (en) 2012-12-05 2013-12-05 A method of purifying therapeutic proteins
CA2893373A CA2893373A1 (en) 2012-12-05 2013-12-05 A method of purifying therapeutic proteins
PL13861334T PL2928905T3 (pl) 2012-12-05 2013-12-05 Sposób oczyszczania białek terapeutycznych
ES13861334T ES2711455T3 (es) 2012-12-05 2013-12-05 Un método de purificación de proteínas terapéuticas
JP2015545601A JP6411360B2 (ja) 2012-12-05 2013-12-05 治療タンパク質の精製方法
CN201380063945.1A CN104981476B (zh) 2012-12-05 2013-12-05 一种纯化治疗性蛋白质的方法
PCT/AU2013/001414 WO2014085861A1 (en) 2012-12-05 2013-12-05 A method of purifying therapeutic proteins
SG10201911709RA SG10201911709RA (en) 2012-12-05 2013-12-05 A method of purifying therapeutic proteins
BR112015012854-8A BR112015012854B1 (pt) 2012-12-05 2013-12-05 Método para purificar proteínas selecionadas do grupo consistindo em plasminogênio, ativador do plasminogênio tecidual e outra(s) protease(s), solução compreendendo fibrinogênio e/ou fator viii e/ou vwf, seu uso e formulação farmacêutica
TR2019/02450T TR201902450T4 (tr) 2012-12-05 2013-12-05 Terapötik proteinleri saflaştırma yöntemi.
DK13861334.4T DK2928905T3 (en) 2012-12-05 2013-12-05 PROCEDURE FOR CLEANING THERAPEUTIC PROTEINS
US14/649,374 US10188965B2 (en) 2012-12-05 2013-12-05 Hydrophobic charge induction chromatographic depletion of a protein from a solution
RU2015126551A RU2685956C2 (ru) 2012-12-05 2013-12-05 Способ очистки лечебных белков
KR1020157017824A KR102240978B1 (ko) 2012-12-05 2013-12-05 치료학적 단백질의 정제 방법
US14/535,085 US9598461B2 (en) 2013-02-04 2014-11-06 Method of purifying therapeutic proteins
JP2018178301A JP6836562B2 (ja) 2012-12-05 2018-09-25 治療タンパク質の精製方法
US16/214,519 US11426680B2 (en) 2012-12-05 2018-12-10 Hydrophobic charge induction chromatographic protein depleted solution
JP2021016182A JP7774384B2 (ja) 2012-12-05 2021-02-04 治療タンパク質の精製方法

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201261733761P 2012-12-05 2012-12-05
US61/733,761 2012-12-05
EP13153898.5 2013-02-04
EP13153898 2013-02-04

Publications (2)

Publication Number Publication Date
AU2013203357A1 AU2013203357A1 (en) 2014-06-19
AU2013203357B2 true AU2013203357B2 (en) 2015-08-27

Family

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AU2013203357A Active AU2013203357B2 (en) 2012-12-05 2013-04-10 A method of purifying therapeutic proteins
AU2013354899A Active AU2013354899B2 (en) 2012-12-05 2013-12-05 A method of purifying therapeutic proteins

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Application Number Title Priority Date Filing Date
AU2013354899A Active AU2013354899B2 (en) 2012-12-05 2013-12-05 A method of purifying therapeutic proteins

Country Status (12)

Country Link
US (5) US20140154233A1 (https=)
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=)
PL (1) PL2928905T3 (https=)
RU (1) RU2685956C2 (https=)
SG (2) SG11201504372UA (https=)
WO (1) WO2014085861A1 (https=)

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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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