PL2928905T3 - Sposób oczyszczania białek terapeutycznych - Google Patents

Sposób oczyszczania białek terapeutycznych

Info

Publication number
PL2928905T3
PL2928905T3 PL13861334T PL13861334T PL2928905T3 PL 2928905 T3 PL2928905 T3 PL 2928905T3 PL 13861334 T PL13861334 T PL 13861334T PL 13861334 T PL13861334 T PL 13861334T PL 2928905 T3 PL2928905 T3 PL 2928905T3
Authority
PL
Poland
Prior art keywords
therapeutic proteins
clean
clean therapeutic
proteins
therapeutic
Prior art date
Application number
PL13861334T
Other languages
English (en)
Polish (pl)
Inventor
Hung Pham
Jeffrey Michael Hey
Darren Nguy
Original Assignee
Csl Behring Gmbh
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 filed Critical Csl Behring Gmbh
Publication of PL2928905T3 publication Critical patent/PL2928905T3/pl

Links

Classifications

    • 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
    • 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
    • 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)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Hematology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Analytical Chemistry (AREA)
  • Toxicology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Diabetes (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)
PL13861334T 2012-12-05 2013-12-05 Sposób oczyszczania białek terapeutycznych PL2928905T3 (pl)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US201261733761P 2012-12-05 2012-12-05
EP13153898 2013-02-04
US13/803,740 US20140154233A1 (en) 2012-12-05 2013-03-14 Method of purifying therapeutic proteins
AU2013203357A AU2013203357B2 (en) 2012-12-05 2013-04-10 A method of purifying therapeutic proteins
EP13861334.4A EP2928905B1 (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

Publications (1)

Publication Number Publication Date
PL2928905T3 true PL2928905T3 (pl) 2019-05-31

Family

ID=47630209

Family Applications (1)

Application Number Title Priority Date Filing Date
PL13861334T PL2928905T3 (pl) 2012-12-05 2013-12-05 Sposób oczyszczania białek terapeutycznych

Country Status (12)

Country Link
US (5) US20140154233A1 (enExample)
EP (2) EP3483173A1 (enExample)
JP (3) JP6411360B2 (enExample)
KR (2) KR102403847B1 (enExample)
CN (2) CN109125714B (enExample)
AU (2) AU2013203357B2 (enExample)
BR (1) BR112015012854B1 (enExample)
CA (2) CA3185085A1 (enExample)
PL (1) PL2928905T3 (enExample)
RU (1) RU2685956C2 (enExample)
SG (2) SG11201504372UA (enExample)
WO (1) WO2014085861A1 (enExample)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013135684A1 (en) 2012-03-13 2013-09-19 Octapharma Ag Improved process for production of fibrinogen and fibrinogen produced thereby
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
WO2017118910A1 (en) * 2016-01-07 2017-07-13 Eio Biomedical Ltd Methods, compositions and kits for reducing tissue adhesions
WO2018007767A1 (fr) 2016-07-06 2018-01-11 Laboratoire Francais Du Fractionnement Et Des Biotechnologies Fibrinogène liquide stable
IL265102B2 (en) * 2016-09-01 2023-11-01 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
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
US20220380439A1 (en) 2020-11-09 2022-12-01 Takeda Pharmaceutical Company Limited Purification of fviii from plasma using silicon oxide adsorption
CA3215331A1 (en) 2021-04-13 2022-10-20 Toshiharu Motokubota 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
MX2024008243A (es) 2021-12-30 2024-09-04 Baxter Int Soluciones de fibrinogeno y trombina para un sellador de fibrina y un kit de sellador de fibrina.

Family Cites Families (36)

* Cited by examiner, † Cited by third party
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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
CA2117058A1 (en) * 1991-09-05 1993-03-18 Daphne C. Tse 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.
CA2195127C (en) * 1994-07-14 2007-06-19 Ruth Laub Concentrate of fibrinogene obtained from blood plasma, process and plant for its preparation
AU3463495A (en) * 1994-09-02 1996-03-27 New York Blood Center, Inc., The Production and secretion of recombinant fibrinogen by yeast
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
DE69931645T2 (de) * 1998-09-24 2007-05-16 Pharming Intellectual Property Bv Reinigung von fibrinogen aus flüssigkeiten mittels ausfällung und hydrophobischer-interaktion-chromatographie
DE60042343D1 (de) * 1999-12-23 2009-07-16 Csl Ltd Abtrennung von fibrinogen von plasmaproteasen
WO2001046016A1 (en) 1999-12-23 2001-06-28 Rast Rodger H System and method for providing individualized dosing
DE10022092A1 (de) * 2000-05-08 2001-11-15 Aventis Behring Gmbh Stabilisiertes Protein-Präparat und Verfahren zu seiner Herstellung
PL205685B1 (pl) * 2001-05-21 2010-05-31 Omrix Biopharm Sa Sposób in vitro usuwania lub wyodrębniania plazminogenu lub plazminy w obecności fibrynogenu, stałe podłoże powinowactwa do oczyszczania mieszaniny zawierającej fibrynogen i plazminę i/lub plazminogen oraz krioprecypitat
AUPR638801A0 (en) 2001-07-13 2001-08-09 Life Therapeutics Limited Factor viii separation
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EP2167526B1 (en) 2007-07-11 2011-03-30 Novo Nordisk A/S Purification of factor viii using a mixed-mode or multimodal resin
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
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SI2300497T1 (sl) * 2008-06-24 2013-02-28 Octapharma Ag Postopek za äťiĺˇäťenje koagulacijskega faktorja viii
CA2785594C (en) * 2010-01-08 2018-04-17 Profibrix Bv Fibrinogen preparations enriched in fibrinogen with an extended alpha chain
ES2586698T3 (es) * 2010-09-20 2016-10-18 Octapharma Ag Proceso para la producción de fibrinógeno
EP2649087A1 (en) * 2010-12-08 2013-10-16 Amgen Inc. Ion exchange chromatography in the presence of an amino acid
WO2013135684A1 (en) 2012-03-13 2013-09-19 Octapharma Ag Improved process for production of fibrinogen and fibrinogen produced thereby
US20140154233A1 (en) 2012-12-05 2014-06-05 Csl Limited Method of purifying therapeutic proteins

Also Published As

Publication number Publication date
CA3185085A1 (en) 2014-06-12
US11426680B2 (en) 2022-08-30
CA2893373A1 (en) 2014-06-12
BR112015012854A2 (pt) 2017-07-11
HK1214833A1 (en) 2016-08-05
EP3483173A1 (en) 2019-05-15
KR20150090252A (ko) 2015-08-05
CN104981476A (zh) 2015-10-14
JP2016501878A (ja) 2016-01-21
EP2928905A4 (en) 2016-06-08
US20190209948A1 (en) 2019-07-11
JP2021073280A (ja) 2021-05-13
JP6411360B2 (ja) 2018-10-24
RU2015126551A (ru) 2017-01-10
US20140154233A1 (en) 2014-06-05
AU2013354899A1 (en) 2015-07-16
JP2019011346A (ja) 2019-01-24
JP6836562B2 (ja) 2021-03-03
US20170143805A1 (en) 2017-05-25
JP7774384B2 (ja) 2025-11-21
KR102403847B1 (ko) 2022-05-31
BR112015012854B1 (pt) 2021-11-30
WO2014085861A1 (en) 2014-06-12
KR20210042422A (ko) 2021-04-19
CN104981476B (zh) 2018-10-09
SG10201704484QA (en) 2017-07-28
AU2013203357B2 (en) 2015-08-27
US20210283530A1 (en) 2021-09-16
CN109125714A (zh) 2019-01-04
US9598461B2 (en) 2017-03-21
KR102240978B1 (ko) 2021-04-19
EP2928905B1 (en) 2018-11-21
RU2685956C2 (ru) 2019-04-23
US20150158906A1 (en) 2015-06-11
SG11201504372UA (en) 2015-07-30
AU2013354899B2 (en) 2018-05-17
CN109125714B (zh) 2022-08-02
EP2928905A1 (en) 2015-10-14
AU2013203357A1 (en) 2014-06-19

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