DK2531218T3 - Immunoglobulinpræparat - Google Patents

Immunoglobulinpræparat Download PDF

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Publication number
DK2531218T3
DK2531218T3 DK11702054.5T DK11702054T DK2531218T3 DK 2531218 T3 DK2531218 T3 DK 2531218T3 DK 11702054 T DK11702054 T DK 11702054T DK 2531218 T3 DK2531218 T3 DK 2531218T3
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DK
Denmark
Prior art keywords
immunoglobulin
proline
preparation
mpa
viscosity
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Application number
DK11702054.5T
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English (en)
Inventor
Reinhard Franz Bolli
Werner Maeder
Peter Lerch
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Csl Behring Ag
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=42211669&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK2531218(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Csl Behring Ag filed Critical Csl Behring Ag
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Publication of DK2531218T3 publication Critical patent/DK2531218T3/da

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39566Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against immunoglobulins, e.g. anti-idiotypic antibodies
    • 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
    • A61P37/00Drugs for immunological or allergic disorders
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)

Claims (14)

1. Anvendelse af prolin til reducering af viskositeten i et immunoglobulinpræparat, hvor immunoglobulinpræparatet omfatter immunoglobulin ved en masse-volumen-procent på mindst 18%, mere fortrinsvis mindst 19 %, mest fortrinsvis mindst 20 %.
2. Anvendelse ifølge krav 1, hvor prolin er L-prolin.
3. Fremgangsmåde til fremstilling af et immunoglobulinpræparat, der omfatter immunoglobulin ved en masse-volumen-procent på mindst 18%, hvor fremgangsmåden omfatter trinet tilsætning af prolin til reducering af viskositeten i præparatet, hvor prolin tilsættes ved en masse-volumen-procent af immunoglobulin på mindre end 15% før opkoncentrering af immunoglobulinpræparatet til masse-volumen-procenten af immunoglobulin på mindst 18 %.
4. Fremgangsmåde ifølge krav 3, hvor prolin er L-prolin.
5. Fremgangsmåde ifølge krav 3 eller 4, hvor immunoglobulinet i immunoglobulinpræparatet i det væsentlige består af IgG.
6. Fremgangsmåde ifølge et hvilket som helst af kravene 3 til 5, hvor mængden af tilsat prolin er således, at koncentrationen af prolin i immunoglobulinpræparatet ligger i intervallet fra 10 til 1000 mmol/l, fortrinsvis fra 10 til 500 mmol/l, mere fortrinsvis fra 100 til 500 mmol/l og mest fortrinsvis er 250 mmol/l.
7. Fremgangsmåde ifølge et hvilket som helst af kravene 3 til 6 til fremstilling af et immunoglobulinpræparat, der omfatter immunoglobulin ved en masse-volumen-procent i intervallet fra 18% til mindre end 20%, hvor prolin tilsættes i en mængde, således at viskositeten er mindre end 13 mPa-s, fortrinsvis mindre end 11 mPa-s, mere fortrinsvis mindre end 10 mPa-s og mest fortrinsvis mindre end 9 mPa-s, hvor viskositeten måles med et faldende kugle-viskosimeter ifølge Hoppier i henhold til European Pharmacopoeia version 6.0, kapitel 2.2.49 og kravene i DIN 53015, ved en temperatur på 20,0 °C +/- 0,1 °C.
8. Fremgangsmåde ifølge et hvilket som helst af kravene 3 til 6 til fremstilling af et immunoglobulinpræparat, der omfatter immunoglobulin i en masse-volumen-procent på mindst 20 %, hvor prolin tilsættes i en mængde, således at viskositeten er mindre end 19 mPa-s, fortrinsvis mindre end 17 mPa-s, mere fortrinsvis mindre end 15 mPa-s og mest fortrinsvis mindre end 13 mPa-s, hvor viskositeten måles med et faldende kugle-viskosimeter ifølge Hoppier i henhold til European Pharmacopoeia Version 6.0, kapitel 2.2.49 og kravene i DIN 53015, ved en temperatur på 20,0 °C +/- 0,1 °C.
9. Immunoglobulinpræparat, der kan opnås ved hjælp af fremgangsmåden ifølge et hvilket som helst af kravene 3 til 8.
10. Immunoglobulinpræparat ifølge krav 9, der omfatter immunoglobulin i en masse-volumen-procent på mindst 20 %, hvor præparatet omfatter prolin i en mængde, således at viskositeten er mindre end 19 mPa-s, fortrinsvis mindre end 17 mPa-s, mere fortrinsvis mindre end 15 mPa-s og mest fortrinsvis mindre end 13 mPa-s, eller omfatter immunoglobulin i en masse-volumenprocent i intervallet fra 18 % til mindre end 20 %, hvor prolin tilsættes i en mængde, således at viskositeten er mindre end 13 mPa-s, fortrinsvis mindre end 11 mPa-s, mere fortrinsvis mindre end 10 mPa-s og mest fortrinsvis mindre end 9 mPa-s, hvor viskositeten måles med et faldende kugle-viskosimeter ifølge Hoppier i henhold til European Pharmacopoeia Version 6.0, kapitel 2.2.49 og kravene i DIN 53015, ved en temperatur på 20,0 °C +/-0,1 °C.
11. Immunoglobulinpræparat ifølge krav 10, der omfatter immunoglobulin i en masse-volumen-procent på 20 %.
12. Immunoglobulinpræparat ifølge krav 11, hvor præparatet har et pH, der ligger i intervallet fra 4,2 til 5,4, fortrinsvis fra 4,6 til 5,0 og mest fortrinsvis er 4,8.
13. Immunoglobulinpræparat ifølge krav 11 eller 12 til subkutan administration til et menneske ved hjælp af direkte manuel indsprøjtning fra en sprøjte.
14. Anvendelse ifølge krav 1, hvor prolin fungerer som et enkeltstof til reducering af viskositeten og forøgelse af stabiliteten af et immunoglobulinpræparat.
DK11702054.5T 2010-02-04 2011-02-03 Immunoglobulinpræparat DK2531218T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP10001164 2010-02-04
PCT/EP2011/051556 WO2011095543A1 (en) 2010-02-04 2011-02-03 Immunoglobulin preparation

Publications (1)

Publication Number Publication Date
DK2531218T3 true DK2531218T3 (da) 2019-04-01

Family

ID=42211669

Family Applications (1)

Application Number Title Priority Date Filing Date
DK11702054.5T DK2531218T3 (da) 2010-02-04 2011-02-03 Immunoglobulinpræparat

Country Status (12)

Country Link
US (4) US9241897B2 (da)
EP (1) EP2531218B1 (da)
JP (2) JP6078344B2 (da)
KR (1) KR101912169B1 (da)
CN (1) CN102753197B (da)
AU (1) AU2011212440B2 (da)
CA (1) CA2788863C (da)
DK (1) DK2531218T3 (da)
ES (1) ES2716088T3 (da)
PL (1) PL2531218T3 (da)
TR (1) TR201903403T4 (da)
WO (1) WO2011095543A1 (da)

Families Citing this family (13)

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Also Published As

Publication number Publication date
WO2011095543A1 (en) 2011-08-11
JP2013518852A (ja) 2013-05-23
JP2016106108A (ja) 2016-06-16
US20220118092A1 (en) 2022-04-21
PL2531218T3 (pl) 2019-05-31
US20120308557A1 (en) 2012-12-06
AU2011212440B2 (en) 2015-01-22
TR201903403T4 (tr) 2019-04-22
US20160151495A1 (en) 2016-06-02
CA2788863C (en) 2020-07-07
KR20120125512A (ko) 2012-11-15
EP2531218B1 (en) 2018-12-12
US20180360969A1 (en) 2018-12-20
JP6078344B2 (ja) 2017-02-08
EP2531218A1 (en) 2012-12-12
AU2011212440A1 (en) 2012-08-16
CA2788863A1 (en) 2011-08-11
CN102753197A (zh) 2012-10-24
KR101912169B1 (ko) 2018-10-26
US9241897B2 (en) 2016-01-26
US10137197B2 (en) 2018-11-27
ES2716088T3 (es) 2019-06-10
CN102753197B (zh) 2014-05-14

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