RU2007109062A - Стабилизирующие препараты - Google Patents
Стабилизирующие препараты Download PDFInfo
- Publication number
- RU2007109062A RU2007109062A RU2007109062/13A RU2007109062A RU2007109062A RU 2007109062 A RU2007109062 A RU 2007109062A RU 2007109062/13 A RU2007109062/13 A RU 2007109062/13A RU 2007109062 A RU2007109062 A RU 2007109062A RU 2007109062 A RU2007109062 A RU 2007109062A
- Authority
- RU
- Russia
- Prior art keywords
- protein
- drug
- antibody
- stable
- molecular weight
- Prior art date
Links
- 239000003814 drug Substances 0.000 title claims 39
- 229940079593 drug Drugs 0.000 title claims 39
- 230000000087 stabilizing effect Effects 0.000 title 1
- 108090000623 proteins and genes Proteins 0.000 claims 45
- 102000004169 proteins and genes Human genes 0.000 claims 45
- 238000000034 method Methods 0.000 claims 24
- 238000002360 preparation method Methods 0.000 claims 15
- 229920001184 polypeptide Polymers 0.000 claims 9
- 108090000765 processed proteins & peptides Proteins 0.000 claims 9
- 102000004196 processed proteins & peptides Human genes 0.000 claims 9
- 239000007864 aqueous solution Substances 0.000 claims 7
- 239000000872 buffer Substances 0.000 claims 6
- 230000000694 effects Effects 0.000 claims 3
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 2
- MXKCYTKUIDTFLY-ZNNSSXPHSA-N alpha-L-Fucp-(1->2)-beta-D-Galp-(1->4)-[alpha-L-Fucp-(1->3)]-beta-D-GlcpNAc-(1->3)-D-Galp Chemical compound O[C@H]1[C@H](O)[C@H](O)[C@H](C)O[C@H]1O[C@H]1[C@H](O[C@H]2[C@@H]([C@@H](NC(C)=O)[C@H](O[C@H]3[C@H]([C@@H](CO)OC(O)[C@@H]3O)O)O[C@@H]2CO)O[C@H]2[C@H]([C@H](O)[C@H](O)[C@H](C)O2)O)O[C@H](CO)[C@H](O)[C@@H]1O MXKCYTKUIDTFLY-ZNNSSXPHSA-N 0.000 claims 2
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 claims 1
- 101800000263 Acidic protein Proteins 0.000 claims 1
- 102100038080 B-cell receptor CD22 Human genes 0.000 claims 1
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims 1
- 238000002965 ELISA Methods 0.000 claims 1
- 101000884305 Homo sapiens B-cell receptor CD22 Proteins 0.000 claims 1
- 101710093543 Probable non-specific lipid-transfer protein Proteins 0.000 claims 1
- 102000007056 Recombinant Fusion Proteins Human genes 0.000 claims 1
- 108010008281 Recombinant Fusion Proteins Proteins 0.000 claims 1
- 239000008351 acetate buffer Substances 0.000 claims 1
- 239000002253 acid Substances 0.000 claims 1
- 230000002378 acidificating effect Effects 0.000 claims 1
- 239000002577 cryoprotective agent Substances 0.000 claims 1
- 230000008014 freezing Effects 0.000 claims 1
- 238000007710 freezing Methods 0.000 claims 1
- 108091005573 modified proteins Proteins 0.000 claims 1
- 102000035118 modified proteins Human genes 0.000 claims 1
- 239000008363 phosphate buffer Substances 0.000 claims 1
- 239000007981 phosphate-citrate buffer Substances 0.000 claims 1
- 150000003839 salts Chemical class 0.000 claims 1
- 239000011780 sodium chloride Substances 0.000 claims 1
- 239000008223 sterile water Substances 0.000 claims 1
- 239000000126 substance Substances 0.000 claims 1
- 239000008362 succinate buffer Substances 0.000 claims 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-L succinate(2-) Chemical compound [O-]C(=O)CCC([O-])=O KDYFGRWQOYBRFD-UHFFFAOYSA-L 0.000 claims 1
- 239000004094 surface-active agent Substances 0.000 claims 1
- 230000001225 therapeutic effect Effects 0.000 claims 1
- 239000003053 toxin Substances 0.000 claims 1
- 231100000765 toxin Toxicity 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
- C07K16/065—Purification, fragmentation
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2896—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Immunology (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Cell Biology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US60131104P | 2004-08-13 | 2004-08-13 | |
| US60/601,311 | 2004-08-13 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| RU2007109062A true RU2007109062A (ru) | 2008-09-20 |
Family
ID=35908214
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2007109062/13A RU2007109062A (ru) | 2004-08-13 | 2005-08-12 | Стабилизирующие препараты |
Country Status (18)
| Country | Link |
|---|---|
| US (1) | US8871201B2 (enExample) |
| EP (1) | EP1784219B1 (enExample) |
| JP (1) | JP4948407B2 (enExample) |
| KR (1) | KR20070092197A (enExample) |
| CN (1) | CN101022831A (enExample) |
| AR (1) | AR051009A1 (enExample) |
| AU (1) | AU2005272603A1 (enExample) |
| BR (1) | BRPI0514340A (enExample) |
| CA (1) | CA2575870A1 (enExample) |
| CR (1) | CR8904A (enExample) |
| EC (1) | ECSP077246A (enExample) |
| ES (1) | ES2637854T3 (enExample) |
| IL (1) | IL181265A0 (enExample) |
| MX (1) | MX2007001599A (enExample) |
| NO (1) | NO20070930L (enExample) |
| RU (1) | RU2007109062A (enExample) |
| TW (1) | TW200621282A (enExample) |
| WO (1) | WO2006020935A2 (enExample) |
Families Citing this family (36)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JO3000B1 (ar) | 2004-10-20 | 2016-09-05 | Genentech Inc | مركبات أجسام مضادة . |
| EP1909831A4 (en) | 2005-06-14 | 2013-02-20 | Amgen Inc | SELF-BUFFING PROTEIN FORMULATIONS |
| GEP20125628B (en) * | 2006-04-21 | 2012-09-10 | Novartis Ag | Pharmaceutical compositions containing antagonist anti-cd40 antibody |
| AU2007240732B2 (en) * | 2006-04-21 | 2013-07-04 | Amgen, Inc. | Buffering agents for biopharmaceutical formulations |
| US20080070230A1 (en) * | 2006-06-12 | 2008-03-20 | Wyeth | Methods for reducing or preventing liquid-liquid phase separation in high concentration protein solutions |
| EP1950225A1 (de) * | 2007-01-25 | 2008-07-30 | Octapharma AG | Verfahren zur Steigerung von Proteinausbeuten |
| EP2527364A1 (en) * | 2007-03-29 | 2012-11-28 | Abbott Laboratories | Crystalline anti-human IL-12 antibodies |
| TWI661833B (zh) * | 2007-11-30 | 2019-06-11 | 百慕達商艾伯維生物技術有限責任公司 | 蛋白質調配物及製造其之方法 |
| US8883146B2 (en) | 2007-11-30 | 2014-11-11 | Abbvie Inc. | Protein formulations and methods of making same |
| CN104398471A (zh) * | 2008-11-28 | 2015-03-11 | Abbvie公司 | 稳定的抗体组合物和用于稳定其的方法 |
| US9265834B2 (en) | 2009-03-05 | 2016-02-23 | Ablynx N.V. | Stable formulations of polypeptides and uses thereof |
| US10005830B2 (en) | 2009-03-05 | 2018-06-26 | Ablynx N.V. | Antigen binding dimer-complexes, methods of making/avoiding and uses thereof |
| NZ613809A (en) * | 2009-05-04 | 2015-02-27 | Abbvie Biotechnology Ltd | Stable high protein concentration formulations of human anti-tnf-alpha-antibodies |
| PT2473528E (pt) | 2009-09-03 | 2015-03-04 | Ablynx NV | Formulações estáveis de polipéptidos e seus usos |
| WO2013006454A1 (en) | 2011-07-01 | 2013-01-10 | Biogen Idec Ma Inc. | Arginine - free tnfr : fc- fusion polypeptide compositions and methods of use |
| AU2012345768B2 (en) | 2011-11-30 | 2016-05-12 | Kindeva Drug Delivery L.P. | Microneedle device having a peptide therapeutic agent and an amino acid, methods of making and using the same |
| CA3204402A1 (en) * | 2012-03-26 | 2013-10-03 | Sanofi | Stable anti-cxcr5 igg4 antibody formulations |
| US9592289B2 (en) | 2012-03-26 | 2017-03-14 | Sanofi | Stable IgG4 based binding agent formulations |
| US8883979B2 (en) | 2012-08-31 | 2014-11-11 | Bayer Healthcare Llc | Anti-prolactin receptor antibody formulations |
| US9844594B2 (en) * | 2012-12-18 | 2017-12-19 | Merck Sharp & Dohme Corp. | Liquid formulations for an anti-TNF α antibody |
| EP3065780A1 (en) | 2013-11-04 | 2016-09-14 | Pfizer Inc. | Anti-efna4 antibody-drug conjugates |
| PT3122426T (pt) | 2014-03-28 | 2023-02-28 | Univ Duke | Tratamento de cancro da mama utilizando moduladores seletivos do recetor de estrogénio |
| GB201412658D0 (en) | 2014-07-16 | 2014-08-27 | Ucb Biopharma Sprl | Molecules |
| JP6629831B2 (ja) * | 2014-07-21 | 2020-01-15 | アンチェインド ラブス | Δｇ値の濃度依存性に基づくタンパク質凝集の定量 |
| EP3288383A4 (en) | 2015-04-29 | 2019-01-23 | Radius Pharmaceuticals, Inc. | METHOD FOR THE TREATMENT OF CANCER |
| GB201601075D0 (en) | 2016-01-20 | 2016-03-02 | Ucb Biopharma Sprl | Antibodies molecules |
| GB201601077D0 (en) | 2016-01-20 | 2016-03-02 | Ucb Biopharma Sprl | Antibody molecule |
| GB201601073D0 (en) | 2016-01-20 | 2016-03-02 | Ucb Biopharma Sprl | Antibodies |
| SG11201900895QA (en) | 2016-08-18 | 2019-02-27 | Regeneron Pharma | Assay for determining potential to self-association of a protein using concentration-dependent self-interaction nanoparticle spectroscopy |
| AU2017345490B2 (en) | 2016-10-21 | 2022-07-07 | Amgen Inc. | Pharmaceutical formulations and methods of making the same |
| ES2981967T3 (es) | 2017-01-05 | 2024-10-14 | Radius Pharmaceuticals Inc | Formas polimórficas de RAD1901-2HCl |
| JP7473486B2 (ja) | 2018-07-04 | 2024-04-23 | ラジウス ファーマシューティカルズ，インコーポレイテッド | Ｒａｄ１９０１－２ｈｃｌの多形形態 |
| JOP20210218A1 (ar) | 2019-02-12 | 2023-01-30 | Radius Pharmaceuticals Inc | عمليات ومركبات |
| US20230167153A1 (en) * | 2020-05-01 | 2023-06-01 | Kashiv Biosciences, Llc | An improved process of purification of protein |
| JP2024503462A (ja) * | 2021-01-14 | 2024-01-25 | ハノル バイオファーマ カンパニーリミテッド | 安定化剤を使用せずに安定した、タンパーナセプトを含む眼科用組成物 |
| CN115541895B (zh) * | 2022-11-29 | 2023-05-19 | 天津德祥生物技术股份有限公司 | 一种提高微流控反定检测卡灵敏度的配方液及应用 |
Family Cites Families (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3176517D1 (en) * | 1980-04-24 | 1987-12-17 | Beecham Group Plc | Beta-lactam compounds, their preparation and use |
| GB8518416D0 (en) | 1985-07-22 | 1985-08-29 | Beecham Group Plc | Compounds |
| US5869053A (en) * | 1988-03-04 | 1999-02-09 | Cancer Research Campaign Technology, Ltd. | 5T4 antigen from human trophoblasts |
| US6267958B1 (en) * | 1995-07-27 | 2001-07-31 | Genentech, Inc. | Protein formulation |
| EP0852951A1 (de) | 1996-11-19 | 1998-07-15 | Roche Diagnostics GmbH | Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern |
| US6306393B1 (en) * | 1997-03-24 | 2001-10-23 | Immunomedics, Inc. | Immunotherapy of B-cell malignancies using anti-CD22 antibodies |
| AU747602B2 (en) * | 1997-06-04 | 2002-05-16 | Oxford Biomedica (Uk) Limited | Vector |
| DK0999853T3 (da) | 1997-06-13 | 2003-04-22 | Genentech Inc | Stabiliseret antostofformulering |
| AU2444899A (en) | 1998-01-22 | 1999-08-09 | Astrazeneca Ab | Pharmaceutical formulation comprising an antibody and a citrate buffer |
| EP1254666A4 (en) * | 1999-12-28 | 2004-12-22 | Chugai Pharmaceutical Co Ltd | STABLE ANTIBODY COMPOSITIONS AND INJECTION FORMULATIONS |
| WO2002013860A1 (en) | 2000-08-11 | 2002-02-21 | Chugai Seiyaku Kabushiki Kaisha | Stabilized antibody-containing preparations |
| IL155002A0 (en) * | 2000-10-12 | 2003-10-31 | Genentech Inc | Reduced-viscosity concentrated protein formulations |
| GB0113179D0 (en) * | 2001-05-31 | 2001-07-25 | Novartis Ag | Organic compounds |
| US20050031627A1 (en) * | 2002-01-03 | 2005-02-10 | Mazzola Gregory J | Methods for preparing immunoconjugates |
| TWI438010B (zh) * | 2002-05-02 | 2014-05-21 | Wyeth Corp | 卡奇黴素（ｃａｌｉｃｈｅａｍｉｃｉｎ）衍生物-載體共軛物 |
| CN1671741A (zh) | 2002-06-21 | 2005-09-21 | 拜奥根Idec公司 | 浓缩抗体的缓冲剂制剂及其使用方法 |
| US20040033228A1 (en) | 2002-08-16 | 2004-02-19 | Hans-Juergen Krause | Formulation of human antibodies for treating TNF-alpha associated disorders |
| CN1867587A (zh) | 2003-08-14 | 2006-11-22 | 惠氏公司 | 抗Lewis Y抗独特型抗体及其用途 |
| TW200616662A (en) * | 2004-09-10 | 2006-06-01 | Wyeth Corp | Humanized anti-5t4 antibodies and anti-5t4 antibody/calicheamicin conjugates |
-
2005
- 2005-08-11 TW TW094127308A patent/TW200621282A/zh unknown
- 2005-08-12 JP JP2007525855A patent/JP4948407B2/ja not_active Expired - Lifetime
- 2005-08-12 AU AU2005272603A patent/AU2005272603A1/en not_active Abandoned
- 2005-08-12 WO PCT/US2005/028861 patent/WO2006020935A2/en not_active Ceased
- 2005-08-12 US US11/203,367 patent/US8871201B2/en active Active
- 2005-08-12 MX MX2007001599A patent/MX2007001599A/es unknown
- 2005-08-12 CA CA002575870A patent/CA2575870A1/en not_active Abandoned
- 2005-08-12 KR KR1020077003502A patent/KR20070092197A/ko not_active Withdrawn
- 2005-08-12 CN CNA2005800274833A patent/CN101022831A/zh active Pending
- 2005-08-12 EP EP05803522.1A patent/EP1784219B1/en not_active Expired - Lifetime
- 2005-08-12 BR BRPI0514340-3A patent/BRPI0514340A/pt not_active IP Right Cessation
- 2005-08-12 RU RU2007109062/13A patent/RU2007109062A/ru not_active Application Discontinuation
- 2005-08-12 ES ES05803522.1T patent/ES2637854T3/es not_active Expired - Lifetime
- 2005-08-16 AR ARP050103456A patent/AR051009A1/es unknown
-
2007
- 2007-02-06 CR CR8904A patent/CR8904A/es not_active Application Discontinuation
- 2007-02-11 IL IL181265A patent/IL181265A0/en unknown
- 2007-02-13 EC EC2007007246A patent/ECSP077246A/es unknown
- 2007-02-19 NO NO20070930A patent/NO20070930L/no not_active Application Discontinuation
Also Published As
| Publication number | Publication date |
|---|---|
| EP1784219A4 (en) | 2010-02-17 |
| ES2637854T3 (es) | 2017-10-17 |
| JP2008515775A (ja) | 2008-05-15 |
| US20060115472A1 (en) | 2006-06-01 |
| EP1784219A2 (en) | 2007-05-16 |
| KR20070092197A (ko) | 2007-09-12 |
| CR8904A (es) | 2007-08-28 |
| NO20070930L (no) | 2007-05-14 |
| CN101022831A (zh) | 2007-08-22 |
| AR051009A1 (es) | 2006-12-13 |
| CA2575870A1 (en) | 2006-02-23 |
| AU2005272603A1 (en) | 2006-02-23 |
| JP4948407B2 (ja) | 2012-06-06 |
| EP1784219B1 (en) | 2017-05-17 |
| WO2006020935A2 (en) | 2006-02-23 |
| TW200621282A (en) | 2006-07-01 |
| US8871201B2 (en) | 2014-10-28 |
| BRPI0514340A (pt) | 2008-06-10 |
| IL181265A0 (en) | 2007-07-04 |
| WO2006020935A3 (en) | 2007-03-08 |
| ECSP077246A (es) | 2007-05-30 |
| MX2007001599A (es) | 2007-04-10 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FA94 | Acknowledgement of application withdrawn (non-payment of fees) |
Effective date: 20110512 |