CA2893373A1 - A method of purifying therapeutic proteins - Google Patents

A method of purifying therapeutic proteins Download PDF

Info

Publication number
CA2893373A1
CA2893373A1 CA2893373A CA2893373A CA2893373A1 CA 2893373 A1 CA2893373 A1 CA 2893373A1 CA 2893373 A CA2893373 A CA 2893373A CA 2893373 A CA2893373 A CA 2893373A CA 2893373 A1 CA2893373 A1 CA 2893373A1
Authority
CA
Canada
Prior art keywords
fibrinogen
solution
resin
group
feedstock
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.)
Abandoned
Application number
CA2893373A
Other languages
English (en)
French (fr)
Inventor
Hung Pham
Jeffrey Michael Hey
Darren Nguy
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
CSL Behring GmbH Deutschland
Original Assignee
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 CA3185085A priority Critical patent/CA3185085A1/en
Publication of CA2893373A1 publication Critical patent/CA2893373A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/26Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion
    • B01D15/361Ion-exchange
    • B01D15/363Anion-exchange
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36Blood coagulation or fibrinolysis factors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36Blood coagulation or fibrinolysis factors
    • A61K38/363Fibrinogen
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36Blood coagulation or fibrinolysis factors
    • A61K38/37Factors VIII
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/18Ion-exchange chromatography
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/20Partition-, reverse-phase or hydrophobic interaction chromatography
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/22Affinity chromatography or related techniques based upon selective absorption processes
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745Blood coagulation or fibrinolysis factors
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745Blood coagulation or fibrinolysis factors
    • C07K14/75Fibrinogen
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745Blood coagulation or fibrinolysis factors
    • C07K14/755Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal 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)
CA2893373A 2012-12-05 2013-12-05 A method of purifying therapeutic proteins Abandoned CA2893373A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA3185085A CA3185085A1 (en) 2012-12-05 2013-12-05 A method of purifying therapeutic proteins

Applications Claiming Priority (9)

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
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

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA3185085A Division CA3185085A1 (en) 2012-12-05 2013-12-05 A method of purifying therapeutic proteins

Publications (1)

Publication Number Publication Date
CA2893373A1 true CA2893373A1 (en) 2014-06-12

Family

ID=47630209

Family Applications (2)

Application Number Title Priority Date Filing Date
CA2893373A Abandoned CA2893373A1 (en) 2012-12-05 2013-12-05 A method of purifying therapeutic proteins
CA3185085A Pending CA3185085A1 (en) 2012-12-05 2013-12-05 A method of purifying therapeutic proteins

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA3185085A Pending CA3185085A1 (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=)

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Family Cites Families (36)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4764369A (en) 1983-07-14 1988-08-16 New York Blood Center Inc. Undenatured virus-free biologically active protein derivatives
US4540573A (en) 1983-07-14 1985-09-10 New York Blood Center, Inc. Undenatured virus-free biologically active protein derivatives
FR2632309B1 (fr) * 1988-06-07 1990-08-24 Lille Transfusion Sanguine Procede de purification par voie chromatographique de proteines, notamment de facteur viii, et les produits obtenus
EP0602173B1 (en) * 1991-09-05 1999-05-26 Baxter International Inc. Topical fibrinogen complex
FR2686883B1 (fr) * 1992-02-04 1994-05-13 Aquitaine Develop Transf Sanguin Procede de fabrication de fibrinogene de tres haute purete, fibrinogene de tres haute purete obtenu ainsi qu'une composition pharmaceutique le contenant.
ATE184884T1 (de) 1994-07-14 1999-10-15 Croix Rouge De Belgique Fibrinogenkonzentrate aus blutplasma, verfahren und anlage für ihre herstellung
JPH10505496A (ja) * 1994-09-02 1998-06-02 ニューヨーク ブラッド センター,インコーポレイティド 酵母による組換フィブリノーゲンの生産及び分泌
US6037457A (en) * 1997-01-31 2000-03-14 The University Of North Carolina At Chapel Hill Method for recombinant fibrinogen production
FR2772381B1 (fr) 1997-12-15 2001-06-08 Lab Francais Du Fractionnement Procede de preparation par filtration d'une solution de facteur viii securisee viralement
DK1115745T3 (da) * 1998-09-24 2006-10-02 Pharming Intellectual Pty Bv Oprensning af fibrinogen fra væsker ved udfældning og hydrofob interaktionskromatografi
NZ518692A (en) * 1999-12-23 2004-08-27 Csl Ltd Purified fibrinogen free of destabilising levels of plasminogen and other proteases obtained from a Fraction I paste
EP1220781A4 (en) 1999-12-23 2007-04-18 Rodger H Rast SYSTEM AND METHOD FOR PROVIDING INDIVIDUALIZED DOSAGE
DE10022092A1 (de) * 2000-05-08 2001-11-15 Aventis Behring Gmbh Stabilisiertes Protein-Präparat und Verfahren zu seiner Herstellung
AU2002314081B2 (en) * 2001-05-21 2007-04-05 Omrix Biopharmaceuticals S.A. Removal pf plasmin(Ogen) from protein solutions
AUPR638801A0 (en) 2001-07-13 2001-08-09 Life Therapeutics Limited Factor viii separation
IL161261A0 (en) * 2001-10-03 2004-09-27 Christopher J Woolverton Storage-stable fibrinogen solutions
AU2002340776A1 (en) * 2001-10-30 2003-05-12 Novozymes A/S High throughput isolation of proteins by charge induction chromatography
DE10211632A1 (de) 2002-03-15 2003-10-09 Aventis Behring Gmbh Verfahren zur Abtrennung von Viren aus einer Proteinlösung durch Nanofiltration
WO2003102132A2 (en) 2002-04-26 2003-12-11 Genetech, Inc. Non-affinity purification of proteins
GB0216001D0 (en) 2002-07-10 2002-08-21 Nat Blood Authority Process and composition
DE10261126A1 (de) 2002-08-13 2004-03-04 Aventis Behring Gmbh Lagerungsstabile, flüssige Fibrinogen-Formulierung
DE10246125A1 (de) 2002-10-01 2004-04-15 Aventis Behring Gmbh Konzentrat eines Faktor VIII:C-haltigen von-Willebrand-Faktors und das dazu gehörige Verfahren
ES2214967B1 (es) 2003-03-06 2005-06-16 Probitas Pharma, S.A Procedimiento para la eliminacion de virus en soluciones de fibrinogeno y fibrinogeno obtenido por dicho procedimiento.
DE102004009400A1 (de) * 2004-02-24 2005-09-08 Zlb Behring Gmbh Fibrinogen Reinigung
US20070142629A1 (en) * 2004-06-16 2007-06-21 Ciphergen Biosystems, Inc. Multichemistry fractionation
EP2102335B1 (en) * 2007-01-04 2012-02-22 Crucell Holland B.V. Purification of factor xi
CN101730707B (zh) 2007-07-11 2014-12-17 诺沃-诺迪斯克有限公司 使用混合式或多模式树脂来纯化因子ⅷ
EP2027875A1 (en) * 2007-08-23 2009-02-25 Octapharma AG A Process for Isolation and Purification of a Target Protein free of Prion Protein (PrPSC)
FR2920429B1 (fr) * 2007-08-30 2012-10-05 Lfb Biotechnologies Procede de purification du facteur viii et du facteur von willebrand
KR20100103595A (ko) 2008-01-18 2010-09-27 에프. 호프만-라 로슈 아게 비-글라이코실화된 단백질의 정제
EP2300497B1 (en) 2008-06-24 2012-08-08 Octapharma AG A process of purifying coagulation factor viii
ES2524886T3 (es) * 2010-01-08 2014-12-15 Profibrix Bv Preparados de fibrinógeno enriquecidos en fibrinógeno con una cadena alfa extendida
RU2603103C2 (ru) 2010-09-20 2016-11-20 Октафарма Аг Способ получения фибриногена с использованием сильной анионообменной смолы и содержащий фибриноген продукт
SG191071A1 (en) * 2010-12-08 2013-07-31 Amgen Inc Ion exchange chromatography in the presence of an amino acid
MX351340B (es) 2012-03-13 2017-10-11 Octapharma Ag Proceso mejorado para la produccion de fibrinogeno y fibrinogeno producido por este.
US20140154233A1 (en) 2012-12-05 2014-06-05 Csl Limited Method of purifying therapeutic proteins

Also Published As

Publication number Publication date
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
CN109125714B (zh) 2022-08-02
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
US20140154233A1 (en) 2014-06-05
JP6836562B2 (ja) 2021-03-03
EP3483173A1 (en) 2019-05-15

Similar Documents

Publication Publication Date Title
US11426680B2 (en) Hydrophobic charge induction chromatographic protein depleted solution
AU2003244850B2 (en) Processes for the preparation of fibrinogen
US10188965B2 (en) Hydrophobic charge induction chromatographic depletion of a protein from a solution
HK40007788A (en) Separation of fibrinogen, fviii and/or vwf from plasma proteases by hcic
US20220380439A1 (en) Purification of fviii from plasma using silicon oxide adsorption
HK1214833B (en) A method of purifying therapeutic proteins
ES2711455T3 (es) Un método de purificación de proteínas terapéuticas

Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20181126

FZDE Discontinued

Effective date: 20240227