DK1904522T4 - Fremgangsmåde til rensning af g-csf - Google Patents

Fremgangsmåde til rensning af g-csf Download PDF

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Publication number
DK1904522T4
DK1904522T4 DK06777781.3T DK06777781T DK1904522T4 DK 1904522 T4 DK1904522 T4 DK 1904522T4 DK 06777781 T DK06777781 T DK 06777781T DK 1904522 T4 DK1904522 T4 DK 1904522T4
Authority
DK
Denmark
Prior art keywords
csf
chromatography
purification
recovery
followed
Prior art date
Application number
DK06777781.3T
Other languages
English (en)
Other versions
DK1904522T3 (da
Inventor
Arndt Dietrich
Bernhard Janowski
Jörg Schäffner
Ulrich Kurt Blaschke
Original Assignee
Mylan Pharmaceuticals Inc
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=36999964&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK1904522(T4) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Mylan Pharmaceuticals Inc filed Critical Mylan Pharmaceuticals Inc
Application granted granted Critical
Publication of DK1904522T3 publication Critical patent/DK1904522T3/da
Publication of DK1904522T4 publication Critical patent/DK1904522T4/da

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Classifications

    • 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
    • C07K14/52Cytokines; Lymphokines; Interferons
    • C07K14/53Colony-stimulating factor [CSF]
    • C07K14/535Granulocyte CSF; Granulocyte-macrophage CSF
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/04Immunostimulants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Toxicology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biochemistry (AREA)
  • Communicable Diseases (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Oncology (AREA)
  • Peptides Or Proteins (AREA)
  • Crystals, And After-Treatments Of Crystals (AREA)
  • Separation Using Semi-Permeable Membranes (AREA)
  • Gyroscopes (AREA)
  • Steroid Compounds (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Graft Or Block Polymers (AREA)
  • Flanged Joints, Insulating Joints, And Other Joints (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Transition And Organic Metals Composition Catalysts For Addition Polymerization (AREA)
  • Detergent Compositions (AREA)
  • Excavating Of Shafts Or Tunnels (AREA)
DK06777781.3T 2005-07-15 2006-07-14 Fremgangsmåde til rensning af g-csf DK1904522T4 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102005033250A DE102005033250A1 (de) 2005-07-15 2005-07-15 Verfahren zur Reinigung von G-CSF
PCT/EP2006/064263 WO2007009950A1 (de) 2005-07-15 2006-07-14 Verfahren zur reinigung von g-csf

Publications (2)

Publication Number Publication Date
DK1904522T3 DK1904522T3 (da) 2009-05-25
DK1904522T4 true DK1904522T4 (da) 2020-08-17

Family

ID=36999964

Family Applications (1)

Application Number Title Priority Date Filing Date
DK06777781.3T DK1904522T4 (da) 2005-07-15 2006-07-14 Fremgangsmåde til rensning af g-csf

Country Status (13)

Country Link
US (3) US9815879B2 (da)
EP (2) EP1904522B2 (da)
JP (1) JP2009501195A (da)
AT (1) ATE423131T1 (da)
CA (2) CA2614820C (da)
DE (2) DE102005033250A1 (da)
DK (1) DK1904522T4 (da)
ES (2) ES2322819T5 (da)
HU (1) HUE027724T2 (da)
PL (1) PL1904522T5 (da)
PT (1) PT1904522E (da)
SI (1) SI2058326T2 (da)
WO (1) WO2007009950A1 (da)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102005033250A1 (de) 2005-07-15 2007-01-18 Bioceuticals Arzneimittel Ag Verfahren zur Reinigung von G-CSF
JP5808323B2 (ja) 2009-06-22 2015-11-10 アムジエン・インコーポレーテツド 化学的に制御されたレドックス状態を用いたタンパク質のリフォールディング
EP2445924B2 (en) 2009-06-25 2023-12-13 Amgen Inc. Capture purification processes for proteins expressed in a non-mammalian system
SI2341061T1 (sl) * 2009-12-31 2013-12-31 Arven Ilac Sanayi Ve Ticaret A.S. Nov postopek za pripravo G-CSF-ja (granulocitne kolonije stimulirajočega faktorja)
EP2525787B1 (en) 2010-01-19 2017-03-15 Hanmi Science Co., Ltd. Liquid formulations for long-acting g-csf conjugate
EA022821B1 (ru) 2010-03-17 2016-03-31 Ратиофарм Гмбх Способ получения биологически активного рекомбинантного г-ксф человека
KR101831300B1 (ko) * 2010-10-29 2018-02-23 한미사이언스 주식회사 재조합 대장균으로부터 인간 과립구 콜로니 자극인자를 정제하는 방법
HUP1200172A2 (en) * 2012-03-19 2013-10-28 Richter Gedeon Nyrt Methods for refolding g-csf from inclusion bodies
JP6742300B2 (ja) 2014-07-14 2020-08-19 ジェンノヴァ バイオファーマシューティカルズ リミテッド rHu−GCSFの精製のための新規プロセス
EP3070099A1 (en) * 2015-03-16 2016-09-21 Arven Ilac Sanayi Ve Ticaret A.S. A process for preparing granulocyte colony stimulating factor (g-csf)
WO2022245259A1 (ru) * 2021-05-18 2022-11-24 Акционерное общество "ГЕНЕРИУМ" Способ промышленной очистки ромиплостима

Family Cites Families (31)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4658018A (en) * 1984-03-13 1987-04-14 Immunex Corporation Process for producing homogeneous colony stimulating factor
US4810643A (en) 1985-08-23 1989-03-07 Kirin- Amgen Inc. Production of pluripotent granulocyte colony-stimulating factor
DE3537708A1 (de) 1985-10-23 1987-04-23 Boehringer Mannheim Gmbh Verfahren zur aktivierung von t-pa nach expression in prokaryonten
DE3729863A1 (de) 1987-09-05 1989-03-16 Boehringer Mannheim Gmbh Stabilisierte erythropoietin-lyophilisate
CA1340810C (en) 1988-03-31 1999-11-02 Motoo Yamasaki Polypeptide derivatives of human granulocyte colony stimulating factor
EP0347041A3 (en) 1988-05-13 1990-11-22 Amgen Inc. Compositions and method for treating or preventing infections in animals
ES2063783T3 (es) 1988-06-03 1995-01-16 Chugai Pharmaceutical Co Ltd Factor de cristalino humano de estimulacion de colonias de granulocitos y procedimiento para su preparacion.
DE3835350A1 (de) 1988-10-17 1990-04-19 Boehringer Mannheim Gmbh Aktivierung von gentechnologisch hergestellten, in prokaryonten exprimierten antikoerpern
US5104651A (en) 1988-12-16 1992-04-14 Amgen Inc. Stabilized hydrophobic protein formulations of g-csf
US5055555A (en) 1989-01-05 1991-10-08 Helmut Sassenfeld Purification of G-CSF
DE4014750A1 (de) 1990-05-08 1991-11-14 Boehringer Mannheim Gmbh Muteine des granulozyten-stimulierenden faktors (g-csf)
FR2669646A1 (fr) 1990-11-23 1992-05-29 Lorraine Laminage Procede de traitement d'un effluent aqueux issu d'un procede d'electrozingage, ainsi que procede et installation en comportant application.
DE4242919A1 (de) 1992-12-18 1994-06-23 Boehringer Mannheim Gmbh Verfahren zur Herstellung von lagerstabilen wässrigen pharmazeutischen Zubereitungen von G-CSF
US5331095A (en) 1993-04-12 1994-07-19 Scios Nova Inc. Process for purification of basic fibroblast growth factor
KR100212071B1 (ko) 1994-10-08 1999-08-02 유충식 활성형 인 과립구 콜로니 자극인자의 정제방법
KR0160934B1 (ko) 1996-01-15 1998-11-16 성재갑 효모에서 봉입체로 발현된 재조합 인 과립구 콜로니 자극인자의 정제방법
FR2796071B1 (fr) * 1999-07-08 2001-09-07 Hoechst Marion Roussel Inc Procede de purification de facteur de stimulation de colonies de granulocytes
KR100356140B1 (ko) 1999-07-08 2002-10-19 한미약품공업 주식회사 인간 과립구 콜로니 자극인자 변이체 및 이의 생산 방법
US6646110B2 (en) 2000-01-10 2003-11-11 Maxygen Holdings Ltd. G-CSF polypeptides and conjugates
ATE367398T1 (de) 2000-05-16 2007-08-15 Bolder Biotechnology Inc Verfahren zur rückfaltung von proteinen mit freien cysteinresten
US20020142964A1 (en) 2000-11-02 2002-10-03 Nissen Torben Lauesgaard Single-chain polypeptides
WO2002036626A1 (en) 2000-11-02 2002-05-10 Maxygen Aps Single-chain multimeric polypeptides
SI21102A (sl) * 2001-12-19 2003-06-30 LEK, tovarna farmacevtskih in kemi�nih izdelkov, d.d. Postopek za izolacijo biološko aktivnega granulocitne kolonije stimulirajočega dejavnika
WO2003066669A2 (en) 2002-02-04 2003-08-14 Millipore Corporation Process for removing protein aggregates and virus from a protein solution
US20060234226A1 (en) 2002-04-26 2006-10-19 Fahner Robert L Non-affinity purification of proteins
AU2002345829A1 (en) * 2002-06-24 2004-01-06 Dr. Reddy's Laboratories Ltd. Process for preparing g-csf
EP1527785A1 (en) * 2003-10-27 2005-05-04 Ludwig-Maximilians-Universität München Use of G-CSF for treating ischemia
CN1663962A (zh) 2004-03-01 2005-09-07 重庆富进生物医药有限公司 重组人粒细胞集落刺激因子及其化学修饰物的一步纯化工艺
DE102004041639A1 (de) * 2004-08-27 2006-03-02 Bioceuticals Arzneimittel Ag Verfahren zur Gewinnung von biologisch aktivem humanen G-CSF aus Inclusion Bodies
EP1869078A2 (en) 2005-03-17 2007-12-26 Zenotech Laboratories Limited Process for the purification of recombinant granulocyte-colony stimulating factor
DE102005033250A1 (de) 2005-07-15 2007-01-18 Bioceuticals Arzneimittel Ag Verfahren zur Reinigung von G-CSF

Also Published As

Publication number Publication date
DE102005033250A1 (de) 2007-01-18
CA2614820C (en) 2013-04-16
DE502006002897D1 (de) 2009-04-02
EP1904522B1 (de) 2009-02-18
PT1904522E (pt) 2009-05-21
US10844103B2 (en) 2020-11-24
US20210070822A1 (en) 2021-03-11
ATE423131T1 (de) 2009-03-15
US20080260684A1 (en) 2008-10-23
ES2545588T3 (es) 2015-09-14
US9815879B2 (en) 2017-11-14
EP2058326B1 (de) 2015-07-08
SI2058326T2 (sl) 2019-09-30
WO2007009950A1 (de) 2007-01-25
EP2058326A1 (de) 2009-05-13
PL1904522T3 (pl) 2009-07-31
SI2058326T1 (sl) 2015-10-30
ES2322819T5 (es) 2021-02-11
EP2058326B2 (de) 2019-05-15
PL1904522T5 (pl) 2021-01-25
US20180094036A1 (en) 2018-04-05
EP1904522B2 (de) 2020-05-27
HUE027724T2 (hu) 2016-11-28
CA2614820A1 (en) 2007-01-25
CA2803048C (en) 2016-09-13
ES2545588T5 (es) 2020-02-13
DK1904522T3 (da) 2009-05-25
EP1904522A1 (de) 2008-04-02
JP2009501195A (ja) 2009-01-15
ES2322819T3 (es) 2009-06-29
CA2803048A1 (en) 2007-01-25

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