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
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Application number
AU2013203357A
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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 EP13861334.4A priority Critical patent/EP2928905B1/en
Priority to DK13861334.4T priority patent/DK2928905T3/en
Priority to SG10201704484QA priority patent/SG10201704484QA/en
Priority to RU2015126551A priority patent/RU2685956C2/ru
Priority to KR1020217010484A priority patent/KR102403847B1/ko
Priority to BR112015012854-8A priority patent/BR112015012854B1/pt
Priority to KR1020157017824A priority patent/KR102240978B1/ko
Priority to CN201380063945.1A priority patent/CN104981476B/zh
Priority to EP18207150.6A priority patent/EP3483173A1/en
Priority to AU2013354899A priority patent/AU2013354899B2/en
Priority to PCT/AU2013/001414 priority patent/WO2014085861A1/en
Priority to SG11201504372UA priority patent/SG11201504372UA/en
Priority to PL13861334T priority patent/PL2928905T3/pl
Priority to HK16102793.7A priority patent/HK1214833B/en
Priority to SG10201911709RA priority patent/SG10201911709RA/en
Priority to ES13861334T priority patent/ES2711455T3/es
Priority to US14/649,374 priority patent/US10188965B2/en
Priority to JP2015545601A priority patent/JP6411360B2/ja
Priority to TR2019/02450T priority patent/TR201902450T4/tr
Priority to CA3185085A priority patent/CA3185085A1/en
Priority to CA2893373A priority patent/CA2893373A1/en
Priority to CN201811091750.9A priority patent/CN109125714B/zh
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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    • 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

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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)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Hematology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Analytical Chemistry (AREA)
  • Toxicology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Epidemiology (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
SG10201911709RA SG10201911709RA (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
RU2015126551A RU2685956C2 (ru) 2012-12-05 2013-12-05 Способ очистки лечебных белков
KR1020217010484A KR102403847B1 (ko) 2012-12-05 2013-12-05 치료학적 단백질의 정제 방법
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
KR1020157017824A KR102240978B1 (ko) 2012-12-05 2013-12-05 치료학적 단백질의 정제 방법
CN201380063945.1A CN104981476B (zh) 2012-12-05 2013-12-05 一种纯化治疗性蛋白质的方法
US14/649,374 US10188965B2 (en) 2012-12-05 2013-12-05 Hydrophobic charge induction chromatographic depletion of a protein from a solution
AU2013354899A AU2013354899B2 (en) 2012-12-05 2013-12-05 A method of purifying therapeutic proteins
PCT/AU2013/001414 WO2014085861A1 (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
PL13861334T PL2928905T3 (pl) 2012-12-05 2013-12-05 Sposób oczyszczania białek terapeutycznych
HK16102793.7A HK1214833B (en) 2012-12-05 2013-12-05 A method of purifying therapeutic proteins
ES13861334T ES2711455T3 (es) 2012-12-05 2013-12-05 Un método de purificación de proteínas terapéuticas
EP13861334.4A EP2928905B1 (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
DK13861334.4T DK2928905T3 (en) 2012-12-05 2013-12-05 PROCEDURE FOR CLEANING THERAPEUTIC PROTEINS
TR2019/02450T TR201902450T4 (tr) 2012-12-05 2013-12-05 Terapötik proteinleri saflaştırma yöntemi.
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
CN201811091750.9A CN109125714B (zh) 2012-12-05 2013-12-05 一种纯化治疗性蛋白质的方法
JP2015545601A JP6411360B2 (ja) 2012-12-05 2013-12-05 治療タンパク質の精製方法
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

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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) EP3483173A1 (https=)
JP (3) JP6411360B2 (https=)
KR (2) KR102240978B1 (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) SG10201704484QA (https=)
WO (1) WO2014085861A1 (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
GB201506113D0 (en) 2015-04-10 2015-05-27 Ge Healthcare Bio Sciences Ab Method for chromatography
GB201506117D0 (en) 2015-04-10 2015-05-27 Ge Healthcare Bio Sciences Ab Method for chromatography
AU2017205364B2 (en) * 2016-01-07 2021-03-04 Eio Biomedical Ltd Methods, compositions and kits for reducing tissue adhesions
EP4293116A3 (fr) 2016-07-06 2024-01-24 Laboratoire Français du Fractionnement et des Biotechnologies Fibrinogène liquide stable
CA3035650A1 (en) * 2016-09-01 2018-03-08 Plas-Free Ltd Human blood-derived products having decreased fibrinolytic activity and uses thereof in hemostatic disorders
KR20200038309A (ko) * 2017-08-23 2020-04-10 체에스엘 베링 게엠베하 폰 빌레브란트 인자의 바이러스 여과 방법
ES2983341T3 (es) * 2018-02-28 2024-10-22 Plas Free Ltd Dispositivo extracorpóreo y matriz para la eliminación de proteínas fibrinolíticas de fluidos biológicos, métodos y usos de los mismos
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
US12173307B2 (en) * 2020-06-24 2024-12-24 Bioverativ Therapeutics Inc. Methods for the purification of viral vectors
CN116322920A (zh) 2020-11-09 2023-06-23 武田药品工业株式会社 使用氧化硅吸附从血浆中纯化fviii
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
EP4456935A1 (en) 2021-12-30 2024-11-06 Baxter International Inc. Fibrinogen and thrombin solutions for a fibrin sealant and fibrin sealant kit

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US7211650B2 (en) * 1998-09-24 2007-05-01 Pharming Intellectual Property Bv Purification of fibrinogen from fluids by precipitation and hydrophoic chromatography
US20050197493A1 (en) * 2004-02-24 2005-09-08 Hubert Metzner Fibrinogen purification
WO2009156430A1 (en) * 2008-06-24 2009-12-30 Octapharma Ag A process of purifying coagulation factor viii
CA2785594A1 (en) * 2010-01-08 2011-07-14 Profibrix Bv Fibrinogen preparations enriched in fibrinogen with an extended alpha chain

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TISSEEL Ready to Use (Calcium chloride, Aprotinin, Human fibrinogen, Human thrombin) PL 00116/0627 ] Retrieved from the internet published 09 December 2008 *

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