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DK1988913T3 - G-CSF-flydende formulering - Google Patents

G-CSF-flydende formulering

Info

Publication number
DK1988913T3
DK1988913T3 DK07712399T DK07712399T DK1988913T3 DK 1988913 T3 DK1988913 T3 DK 1988913T3 DK 07712399 T DK07712399 T DK 07712399T DK 07712399 T DK07712399 T DK 07712399T DK 1988913 T3 DK1988913 T3 DK 1988913T3
Authority
DK
Denmark
Prior art keywords
csf
polysorbate
liquid formulation
pharmaceutical adjuvants
acetate
Prior art date
Application number
DK07712399T
Other languages
Danish (da)
English (en)
Inventor
Michael Mack
Ulrich Kurt Blaschke
Original Assignee
Bioceuticals Arzneimittel Ag
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=38226349&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK1988913(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Bioceuticals Arzneimittel Ag filed Critical Bioceuticals Arzneimittel Ag
Application granted granted Critical
Publication of DK1988913T3 publication Critical patent/DK1988913T3/da

Links

Classifications

    • 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
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/193Colony stimulating factors [CSF]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Dermatology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
DK07712399T 2006-03-01 2007-03-01 G-CSF-flydende formulering DK1988913T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102006009437A DE102006009437A1 (de) 2006-03-01 2006-03-01 G-CSF-Flüssigformulierung
PCT/EP2007/051947 WO2007099145A1 (de) 2006-03-01 2007-03-01 G-csf-flüssigformulierung

Publications (1)

Publication Number Publication Date
DK1988913T3 true DK1988913T3 (da) 2009-08-17

Family

ID=38226349

Family Applications (1)

Application Number Title Priority Date Filing Date
DK07712399T DK1988913T3 (da) 2006-03-01 2007-03-01 G-CSF-flydende formulering

Country Status (14)

Country Link
US (1) US20090247450A1 (pl)
EP (2) EP2098243A1 (pl)
JP (1) JP2009528327A (pl)
AT (1) ATE429243T1 (pl)
CA (1) CA2644461A1 (pl)
CY (1) CY1109223T1 (pl)
DE (4) DE102006009437A1 (pl)
DK (1) DK1988913T3 (pl)
ES (1) ES2326498T3 (pl)
PL (1) PL1988913T3 (pl)
PT (1) PT1988913E (pl)
RU (1) RU2445115C2 (pl)
SI (1) SI1988913T1 (pl)
WO (1) WO2007099145A1 (pl)

Families Citing this family (30)

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US7157277B2 (en) 2001-11-28 2007-01-02 Neose Technologies, Inc. Factor VIII remodeling and glycoconjugation of Factor VIII
US7214660B2 (en) * 2001-10-10 2007-05-08 Neose Technologies, Inc. Erythropoietin: remodeling and glycoconjugation of erythropoietin
US7173003B2 (en) 2001-10-10 2007-02-06 Neose Technologies, Inc. Granulocyte colony stimulating factor: remodeling and glycoconjugation of G-CSF
EP1608688B1 (en) 2003-03-14 2013-02-27 BioGeneriX AG Branched water-soluble polymers and their conjugates
US20070026485A1 (en) 2003-04-09 2007-02-01 Neose Technologies, Inc. Glycopegylation methods and proteins/peptides produced by the methods
US8791070B2 (en) 2003-04-09 2014-07-29 Novo Nordisk A/S Glycopegylated factor IX
WO2005012484A2 (en) 2003-07-25 2005-02-10 Neose Technologies, Inc. Antibody-toxin conjugates
US8633157B2 (en) 2003-11-24 2014-01-21 Novo Nordisk A/S Glycopegylated erythropoietin
US20080305992A1 (en) 2003-11-24 2008-12-11 Neose Technologies, Inc. Glycopegylated erythropoietin
US20060040856A1 (en) 2003-12-03 2006-02-23 Neose Technologies, Inc. Glycopegylated factor IX
NZ548123A (en) 2004-01-08 2010-05-28 Novo Nordisk As O-linked glycosylation of peptides
US20080300173A1 (en) * 2004-07-13 2008-12-04 Defrees Shawn Branched Peg Remodeling and Glycosylation of Glucagon-Like Peptides-1 [Glp-1]
WO2006031811A2 (en) 2004-09-10 2006-03-23 Neose Technologies, Inc. Glycopegylated interferon alpha
EP2586456B1 (en) 2004-10-29 2016-01-20 ratiopharm GmbH Remodeling and glycopegylation of fibroblast growth factor (FGF)
JP4951527B2 (ja) 2005-01-10 2012-06-13 バイオジェネリックス アーゲー 糖peg化顆粒球コロニー刺激因子
US9187546B2 (en) 2005-04-08 2015-11-17 Novo Nordisk A/S Compositions and methods for the preparation of protease resistant human growth hormone glycosylation mutants
US20080255026A1 (en) 2005-05-25 2008-10-16 Glycopegylated Factor 1X Glycopegylated Factor Ix
US20070105755A1 (en) 2005-10-26 2007-05-10 Neose Technologies, Inc. One pot desialylation and glycopegylation of therapeutic peptides
WO2007056191A2 (en) 2005-11-03 2007-05-18 Neose Technologies, Inc. Nucleotide sugar purification using membranes
DE102006009437A1 (de) 2006-03-01 2007-09-13 Bioceuticals Arzneimittel Ag G-CSF-Flüssigformulierung
US20080248959A1 (en) 2006-07-21 2008-10-09 Neose Technologies, Inc. Glycosylation of peptides via o-linked glycosylation sequences
JP2010505874A (ja) 2006-10-03 2010-02-25 ノヴォ ノルディスク アー/エス ポリペプチドコンジュゲートの精製方法
AU2008237411B2 (en) 2007-04-03 2013-10-03 Ratiopharm Gmbh Methods of treatment using glycopegylated G-CSF
WO2008154639A2 (en) 2007-06-12 2008-12-18 Neose Technologies, Inc. Improved process for the production of nucleotide sugars
BRPI0815975B8 (pt) 2007-08-27 2021-05-25 Biogenerix Ag preparação aquosa, recipiente farmacêutico, processo para preparar uma preparação aquosa, e, uso de uma preparação aquosa
DE202007018629U1 (de) * 2007-08-27 2008-12-24 Biogenerix Ag Flüssigformulierung von G-CSF
KR20100044261A (ko) * 2007-08-27 2010-04-29 바이오제너릭스 에이지 G-csf의 액상 조성물
US8207112B2 (en) * 2007-08-29 2012-06-26 Biogenerix Ag Liquid formulation of G-CSF conjugate
WO2009108806A1 (en) 2008-02-27 2009-09-03 Novo Nordisk A/S Conjugated factor viii molecules
EP2399572A1 (en) 2010-06-22 2011-12-28 Sandoz AG Long-term storage of non-glycosylated recombinant human G-CSF

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
GR871067B (en) 1986-07-18 1987-11-19 Chugai Pharmaceutical Co Ltd Process for producing stable pharmaceutical preparation containing granulocyte colony stimulating factor
ATE452190T1 (de) 1988-05-13 2010-01-15 Amgen Inc Verfahren zur isolierung und reinigung von g-csf
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
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.
DE4126983A1 (de) * 1991-08-15 1993-02-18 Boehringer Mannheim Gmbh Verfahren zur herstellung von humanprotein-enthaltenden, konservierten arzneimitteln fuer infusions- oder injektionszwecke
DE4242919A1 (de) 1992-12-18 1994-06-23 Boehringer Mannheim Gmbh Verfahren zur Herstellung von lagerstabilen wässrigen pharmazeutischen Zubereitungen von G-CSF
DE4242863A1 (de) 1992-12-18 1994-06-23 Boehringer Mannheim Gmbh Stabile lyophilisierte pharmazeutische Zubereitungen von G-CSF
GB9300356D0 (en) * 1993-01-09 1993-03-03 Tbs Eng Ltd Apparatus for assembling battery plates
ZA966075B (en) * 1995-07-27 1998-01-19 Genentech Inc Protein formulation.
AU749815B2 (en) * 1998-03-06 2002-07-04 Chugai Seiyaku Kabushiki Kaisha Protein-free preparations
ES2216447T3 (es) * 1998-08-17 2004-10-16 Pfizer Products Inc. Composiciones proteicas estabilizadas.
FR2796071B1 (fr) 1999-07-08 2001-09-07 Hoechst Marion Roussel Inc Procede de purification de facteur de stimulation de colonies de granulocytes
US6555660B2 (en) * 2000-01-10 2003-04-29 Maxygen Holdings Ltd. G-CSF conjugates
AU2001274853B2 (en) 2000-05-16 2007-03-22 Bolder Biotechnology, Inc. Methods for refolding proteins containing free cysteine residues
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
DE10348550A1 (de) * 2003-10-20 2005-06-16 Hexal Biotech Forschungsgmbh Stabile wässrige G-CSF-haltige Zusammensetzungen
US7585496B2 (en) 2003-11-04 2009-09-08 Lek Pharmaceuticals D.D. Stable pharmaceutical composition granulocyte-colony stimulating factor
DE102006009437A1 (de) 2006-03-01 2007-09-13 Bioceuticals Arzneimittel Ag G-CSF-Flüssigformulierung

Also Published As

Publication number Publication date
SI1988913T1 (sl) 2009-10-31
EP1988913B1 (de) 2009-04-22
CY1109223T1 (el) 2014-07-02
DE202006020194U1 (de) 2007-12-06
JP2009528327A (ja) 2009-08-06
DE202007018618U1 (de) 2008-12-11
CA2644461A1 (en) 2007-09-07
PL1988913T3 (pl) 2009-09-30
RU2008138646A (ru) 2010-04-10
WO2007099145A1 (de) 2007-09-07
PT1988913E (pt) 2009-07-16
RU2445115C2 (ru) 2012-03-20
EP2098243A1 (de) 2009-09-09
DE102006009437A1 (de) 2007-09-13
EP1988913A1 (de) 2008-11-12
DE502007000649D1 (de) 2009-06-04
ES2326498T3 (es) 2009-10-13
US20090247450A1 (en) 2009-10-01
ATE429243T1 (de) 2009-05-15

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