KR101333276B1 - 항체의 제제 - Google Patents
항체의 제제 Download PDFInfo
- Publication number
- KR101333276B1 KR101333276B1 KR1020127015910A KR20127015910A KR101333276B1 KR 101333276 B1 KR101333276 B1 KR 101333276B1 KR 1020127015910 A KR1020127015910 A KR 1020127015910A KR 20127015910 A KR20127015910 A KR 20127015910A KR 101333276 B1 KR101333276 B1 KR 101333276B1
- Authority
- KR
- South Korea
- Prior art keywords
- formulation
- histidine
- formulations
- trehalose
- phosphate
- Prior art date
- Legal status (The legal status 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 status listed.)
- Active
Links
- 239000000203 mixture Substances 0.000 title claims abstract description 365
- 238000009472 formulation Methods 0.000 title claims abstract description 353
- 239000000872 buffer Substances 0.000 claims abstract description 34
- 239000002736 nonionic surfactant Substances 0.000 claims abstract description 9
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims description 100
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 claims description 71
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 claims description 71
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 claims description 71
- 239000005720 sucrose Substances 0.000 claims description 66
- 229910019142 PO4 Inorganic materials 0.000 claims description 62
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims description 62
- 239000010452 phosphate Substances 0.000 claims description 62
- 239000004094 surface-active agent Substances 0.000 claims description 14
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 13
- 229930006000 Sucrose Natural products 0.000 claims description 13
- 238000002360 preparation method Methods 0.000 claims description 11
- 235000000346 sugar Nutrition 0.000 claims description 9
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims description 8
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims description 8
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- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 7
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- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 3
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- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 32
- 230000007423 decrease Effects 0.000 description 29
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- 239000011780 sodium chloride Substances 0.000 description 16
- 239000002953 phosphate buffered saline Substances 0.000 description 15
- 238000004255 ion exchange chromatography Methods 0.000 description 13
- 239000007788 liquid Substances 0.000 description 12
- 229920001184 polypeptide Polymers 0.000 description 12
- 108090000765 processed proteins & peptides Proteins 0.000 description 12
- 102000004196 processed proteins & peptides Human genes 0.000 description 12
- 239000003795 chemical substances by application Substances 0.000 description 11
- 239000007857 degradation product Substances 0.000 description 11
- 102000004169 proteins and genes Human genes 0.000 description 11
- 108090000623 proteins and genes Proteins 0.000 description 11
- 125000002066 L-histidyl group Chemical group [H]N1C([H])=NC(C([H])([H])[C@](C(=O)[*])([H])N([H])[H])=C1[H] 0.000 description 10
- 238000009825 accumulation Methods 0.000 description 10
- 230000015572 biosynthetic process Effects 0.000 description 10
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 description 9
- 230000008859 change Effects 0.000 description 9
- 238000003860 storage Methods 0.000 description 8
- 238000007710 freezing Methods 0.000 description 7
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- 239000008363 phosphate buffer Substances 0.000 description 7
- 239000000243 solution Substances 0.000 description 7
- 239000000126 substance Substances 0.000 description 6
- 108060003951 Immunoglobulin Proteins 0.000 description 5
- 239000000427 antigen Substances 0.000 description 5
- 102000036639 antigens Human genes 0.000 description 5
- 108091007433 antigens Proteins 0.000 description 5
- 239000013011 aqueous formulation Substances 0.000 description 5
- 230000004071 biological effect Effects 0.000 description 5
- 102000018358 immunoglobulin Human genes 0.000 description 5
- 238000005342 ion exchange Methods 0.000 description 5
- 229920005862 polyol Polymers 0.000 description 5
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- 238000010257 thawing Methods 0.000 description 5
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- LOKCTEFSRHRXRJ-UHFFFAOYSA-I dipotassium trisodium dihydrogen phosphate hydrogen phosphate dichloride Chemical compound P(=O)(O)(O)[O-].[K+].P(=O)(O)([O-])[O-].[Na+].[Na+].[Cl-].[K+].[Cl-].[Na+] LOKCTEFSRHRXRJ-UHFFFAOYSA-I 0.000 description 2
- 239000003937 drug carrier Substances 0.000 description 2
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- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 description 1
- 108010047041 Complementarity Determining Regions Proteins 0.000 description 1
- BACYUWVYYTXETD-UHFFFAOYSA-N N-Lauroylsarcosine Chemical compound CCCCCCCCCCCC(=O)N(C)CC(O)=O BACYUWVYYTXETD-UHFFFAOYSA-N 0.000 description 1
- 206010057249 Phagocytosis Diseases 0.000 description 1
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- 150000001413 amino acids Chemical class 0.000 description 1
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- 125000002091 cationic group Chemical group 0.000 description 1
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- 238000011161 development Methods 0.000 description 1
- 235000014113 dietary fatty acids Nutrition 0.000 description 1
- 239000003085 diluting agent Substances 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 239000002270 dispersing agent Substances 0.000 description 1
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- 239000003814 drug Substances 0.000 description 1
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- KDYFGRWQOYBRFD-UHFFFAOYSA-L succinate(2-) Chemical compound [O-]C(=O)CCC([O-])=O KDYFGRWQOYBRFD-UHFFFAOYSA-L 0.000 description 1
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Images
Classifications
-
- 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
- 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
- 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
- A61K39/39591—Stabilisation, fragmentation
-
- 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
-
- 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
- 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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- 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)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Immunology (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Dermatology (AREA)
- Organic Chemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN2859/CHE/2009 | 2009-11-20 | ||
| IN2859CH2009 | 2009-11-20 | ||
| PCT/IB2010/055296 WO2011061712A1 (en) | 2009-11-20 | 2010-11-19 | Formulations of antibody |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| KR20130028894A KR20130028894A (ko) | 2013-03-20 |
| KR101333276B1 true KR101333276B1 (ko) | 2013-11-27 |
Family
ID=44059267
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| KR1020127015910A Active KR101333276B1 (ko) | 2009-11-20 | 2010-11-19 | 항체의 제제 |
Country Status (20)
| Country | Link |
|---|---|
| US (4) | US20120231009A1 (enExample) |
| EP (2) | EP2501408B1 (enExample) |
| JP (2) | JP5896471B2 (enExample) |
| KR (1) | KR101333276B1 (enExample) |
| CN (1) | CN102770157B (enExample) |
| AU (1) | AU2010320515B2 (enExample) |
| BR (1) | BR112012012080B1 (enExample) |
| CA (1) | CA2781467C (enExample) |
| CU (1) | CU20120080A7 (enExample) |
| DK (1) | DK3721904T3 (enExample) |
| ES (1) | ES2897500T3 (enExample) |
| IL (1) | IL219884A (enExample) |
| MX (1) | MX2012005863A (enExample) |
| MY (1) | MY165614A (enExample) |
| NZ (1) | NZ600096A (enExample) |
| PL (1) | PL3721904T3 (enExample) |
| PT (1) | PT3721904T (enExample) |
| RU (1) | RU2548772C2 (enExample) |
| WO (1) | WO2011061712A1 (enExample) |
| ZA (1) | ZA201204459B (enExample) |
Families Citing this family (35)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JOP20080381B1 (ar) | 2007-08-23 | 2023-03-28 | Amgen Inc | بروتينات مرتبطة بمولدات مضادات تتفاعل مع بروبروتين كونفيرتاز سيتيليزين ككسين من النوع 9 (pcsk9) |
| BRPI0822447A2 (pt) | 2008-03-14 | 2015-06-16 | Biocon Ltd | Anticorpo monoclonal e método do mesmo |
| US20130064834A1 (en) | 2008-12-15 | 2013-03-14 | Regeneron Pharmaceuticals, Inc. | Methods for treating hypercholesterolemia using antibodies to pcsk9 |
| JO3672B1 (ar) | 2008-12-15 | 2020-08-27 | Regeneron Pharma | أجسام مضادة بشرية عالية التفاعل الكيماوي بالنسبة لإنزيم سبتيليسين كنفرتيز بروبروتين / كيكسين نوع 9 (pcsk9). |
| HRP20180959T1 (hr) | 2011-01-28 | 2018-07-27 | Sanofi Biotechnology | Ljudska protutijela za pcsk9 za uporabu u postupcima liječenja određenih skupina subjekata |
| AR087305A1 (es) * | 2011-07-28 | 2014-03-12 | Regeneron Pharma | Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit |
| CA2848201C (en) | 2011-09-16 | 2020-10-27 | Regeneron Pharmaceuticals, Inc. | Methods for reducing lipoprotein(a) levels by administering an inhibitor of proprotein convertase subtilisin kexin-9 (pcsk9) |
| MY164611A (en) | 2012-01-23 | 2018-01-30 | Regeneron Pharma | Stabilized formulations containing anti-ang2 antibodies |
| AR092325A1 (es) | 2012-05-31 | 2015-04-15 | Regeneron Pharma | Formulaciones estabilizadas que contienen anticuerpos anti-dll4 y kit |
| MX2015003007A (es) | 2012-09-07 | 2015-06-05 | Coherus Biosciences Inc | Formulaciones acuosas estables de adalimumab. |
| CN102961745B (zh) * | 2012-09-27 | 2015-02-18 | 苏州康聚生物科技有限公司 | 抗体组合物制剂及其应用 |
| EP2916866B1 (de) | 2012-11-06 | 2018-04-04 | Bayer Pharma Aktiengesellschaft | Formulierung für bispecific t-cell-engangers (bites) |
| US10111953B2 (en) | 2013-05-30 | 2018-10-30 | Regeneron Pharmaceuticals, Inc. | Methods for reducing remnant cholesterol and other lipoprotein fractions by administering an inhibitor of proprotein convertase subtilisin kexin-9 (PCSK9) |
| US10189899B2 (en) | 2013-07-23 | 2019-01-29 | Biocon Limited | Use of a CD6 binding partner and method based thereon |
| IL312865B2 (en) | 2013-09-11 | 2025-06-01 | Eagle Biologics Inc | Liquid protein formulations containing viscosity-lowering agents |
| CN106062003A (zh) | 2013-11-12 | 2016-10-26 | 赛诺菲生物技术公司 | 用于与pcsk9抑制剂一起使用的给药方案 |
| US10206878B2 (en) * | 2014-05-28 | 2019-02-19 | Nono Inc. | Lyophilized formulation of TAT-NR2B9C with acetylation scavenger |
| KR20170029613A (ko) | 2014-07-16 | 2017-03-15 | 사노피 바이오테크놀로지 | 이형접합성 가족성 고콜레스테롤혈증(heFH) 환자의 치료방법 |
| AU2015325055B2 (en) | 2014-10-01 | 2021-02-25 | Eagle Biologics, Inc. | Polysaccharide and nucleic acid formulations containing viscosity-lowering agents |
| CN104922668B (zh) * | 2014-12-10 | 2019-08-23 | 信达生物制药(苏州)有限公司 | 一种稳定的抗vegf抗体制剂及其用途 |
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