DK2531218T3 - Immunoglobulinpræparat - Google Patents
Immunoglobulinpræparat Download PDFInfo
- 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
- Authority
- DK
- Denmark
- Prior art keywords
- immunoglobulin
- proline
- preparation
- mpa
- viscosity
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/39566—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against immunoglobulins, e.g. anti-idiotypic antibodies
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
Landscapes
- 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.
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)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1532983A1 (en) | 2003-11-18 | 2005-05-25 | ZLB Bioplasma AG | Immunoglobulin preparations having increased stability |
WO2011095543A1 (en) * | 2010-02-04 | 2011-08-11 | Csl Behring Ag | Immunoglobulin preparation |
EP2361636A1 (en) | 2010-02-26 | 2011-08-31 | CSL Behring AG | Immunoglobulin preparation and storage system for an immunoglobulin preparation |
SG193963A1 (en) * | 2011-04-07 | 2013-11-29 | Glaxosmithkline Llc | Formulations with reduced viscosity |
KR101759694B1 (ko) | 2011-10-28 | 2017-07-19 | 인테그리티 바이오, 아이엔씨. | 아미노산을 함유하는 단백질 제제 |
ES2759226T3 (es) * | 2013-02-26 | 2020-05-08 | Baxalta GmbH | Tratamiento de trastornos del sistema nervioso central mediante administración intranasal de inmunoglobulina G |
JP6179939B2 (ja) * | 2013-07-09 | 2017-08-16 | 国立大学法人 筑波大学 | 高濃度γグロブリン製剤の粘度低下方法 |
EP3043775B1 (en) | 2013-09-11 | 2020-11-04 | Eagle Biologics, Inc. | Liquid protein formulations containing viscosity-lowering agents |
WO2015150510A1 (en) * | 2014-04-03 | 2015-10-08 | Csl Behring Ag | Nebulization of immunoglobulin |
KR102497368B1 (ko) | 2014-10-01 | 2023-02-10 | 이글 바이올로직스 인코포레이티드 | 점도-저하제를 함유하는 폴리삭카라이드 및 핵산 제형 |
AU2015335743B2 (en) | 2014-10-23 | 2020-12-24 | Amgen Inc. | Reducing viscosity of pharmaceutical formulations |
JP7116059B2 (ja) * | 2016-11-21 | 2022-08-09 | ジャスト-エヴォテック バイオロジックス、インコーポレイテッド | アフリベルセプト製剤及びその使用 |
WO2020109621A1 (en) | 2018-11-30 | 2020-06-04 | Csl Behring Ag | Methods and compositions for preventing or treating acute exacerbations with polyclonal immunoglobulin |
Family Cites Families (55)
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JP5734985B2 (ja) | 2009-09-17 | 2015-06-17 | バクスター・ヘルスケヤー・ソシエテ・アノニムBaxter Healthcare SA | ヒアルロニダーゼおよび免疫グロブリンの安定な共製剤およびそれらの使用方法 |
EA201891433A3 (ru) | 2010-01-15 | 2019-02-28 | Кирин-Эмджен, Инк. | Состав антитела и терапевтические режимы |
WO2011095543A1 (en) * | 2010-02-04 | 2011-08-11 | Csl Behring Ag | Immunoglobulin preparation |
EP2361636A1 (en) * | 2010-02-26 | 2011-08-31 | CSL Behring AG | Immunoglobulin preparation and storage system for an immunoglobulin preparation |
-
2011
- 2011-02-03 WO PCT/EP2011/051556 patent/WO2011095543A1/en active Application Filing
- 2011-02-03 CN CN201180008195.9A patent/CN102753197B/zh active Active
- 2011-02-03 KR KR1020127022986A patent/KR101912169B1/ko active IP Right Grant
- 2011-02-03 EP EP11702054.5A patent/EP2531218B1/en active Active
- 2011-02-03 PL PL11702054T patent/PL2531218T3/pl unknown
- 2011-02-03 ES ES11702054T patent/ES2716088T3/es active Active
- 2011-02-03 DK DK11702054.5T patent/DK2531218T3/da active
- 2011-02-03 US US13/577,220 patent/US9241897B2/en active Active
- 2011-02-03 CA CA2788863A patent/CA2788863C/en not_active Expired - Fee Related
- 2011-02-03 TR TR2019/03403T patent/TR201903403T4/tr unknown
- 2011-02-03 JP JP2012551619A patent/JP6078344B2/ja active Active
- 2011-02-03 AU AU2011212440A patent/AU2011212440B2/en active Active
-
2015
- 2015-12-15 US US14/970,326 patent/US10137197B2/en active Active
-
2016
- 2016-01-15 JP JP2016005818A patent/JP2016106108A/ja active Pending
-
2018
- 2018-06-15 US US16/009,670 patent/US20180360969A1/en not_active Abandoned
-
2021
- 2021-10-29 US US17/514,957 patent/US20220118092A1/en active Pending
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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