KR100514207B1 - 단클론성 또는 다클론성 항체의 안정한 동결건조 제약학적 물질 - Google Patents
단클론성 또는 다클론성 항체의 안정한 동결건조 제약학적 물질 Download PDFInfo
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- KR100514207B1 KR100514207B1 KR10-1999-7004336A KR19997004336A KR100514207B1 KR 100514207 B1 KR100514207 B1 KR 100514207B1 KR 19997004336 A KR19997004336 A KR 19997004336A KR 100514207 B1 KR100514207 B1 KR 100514207B1
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- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/08—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
- C07K16/081—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from DNA viruses
- C07K16/082—Hepadnaviridae, e.g. hepatitis B virus
-
- 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
- C07K16/2863—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
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- Health & Medical Sciences (AREA)
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- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Immunology (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Communicable Diseases (AREA)
- Virology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Dermatology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP96118489A EP0852951A1 (de) | 1996-11-19 | 1996-11-19 | Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern |
| EP96118489.2 | 1996-11-19 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| KR20000053328A KR20000053328A (ko) | 2000-08-25 |
| KR100514207B1 true KR100514207B1 (ko) | 2005-09-13 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| KR10-1999-7004336A Expired - Lifetime KR100514207B1 (ko) | 1996-11-19 | 1997-11-19 | 단클론성 또는 다클론성 항체의 안정한 동결건조 제약학적 물질 |
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| US (2) | US8758747B2 (enExample) |
| EP (2) | EP0852951A1 (enExample) |
| JP (2) | JP4536829B2 (enExample) |
| KR (1) | KR100514207B1 (enExample) |
| CN (1) | CN1155408C (enExample) |
| AR (2) | AR012540A1 (enExample) |
| AT (1) | ATE276762T1 (enExample) |
| AU (2) | AU735411C (enExample) |
| BR (1) | BR9713521A (enExample) |
| CA (1) | CA2272245C (enExample) |
| DE (1) | DE59711959D1 (enExample) |
| DK (1) | DK0941121T3 (enExample) |
| ES (1) | ES2227727T3 (enExample) |
| ID (1) | ID19029A (enExample) |
| PT (1) | PT941121E (enExample) |
| TR (1) | TR199901696T2 (enExample) |
| TW (1) | TW520291B (enExample) |
| WO (1) | WO1998022136A2 (enExample) |
| ZA (1) | ZA9710409B (enExample) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR101280273B1 (ko) | 2005-04-18 | 2013-07-15 | 예다 리서치 앤드 디벨럽먼트 캄파니 리미티드 | 안정화된 항-ｂ형 간염 바이러스 (ｈｂｖ) 항체 제형 |
Families Citing this family (128)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6685940B2 (en) | 1995-07-27 | 2004-02-03 | Genentech, Inc. | Protein formulation |
| 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 |
| ES2179414T3 (es) * | 1997-11-22 | 2003-01-16 | Roche Diagnostics Gmbh | Procedimiento mejorado de estabilizacion de proteinas. |
| CA2371427A1 (en) * | 1999-04-28 | 2000-11-09 | Yamanouchi Pharmaceutical Co., Ltd. | Parenteral pharmaceutical composition containing humanized monoclonal antibody fragment and stabilizing method thereof |
| WO2002013860A1 (en) | 2000-08-11 | 2002-02-21 | Chugai Seiyaku Kabushiki Kaisha | Stabilized antibody-containing preparations |
| US7138262B1 (en) | 2000-08-18 | 2006-11-21 | Shire Human Genetic Therapies, Inc. | High mannose proteins and methods of making high mannose proteins |
| US8703126B2 (en) | 2000-10-12 | 2014-04-22 | Genentech, Inc. | Reduced-viscosity concentrated protein formulations |
| TWI232102B (en) | 2001-07-17 | 2005-05-11 | Shionogi & Co | A pharmaceutical formulation for injection |
| ATE414537T1 (de) | 2001-08-29 | 2008-12-15 | Chugai Pharmaceutical Co Ltd | Antikörper enthaltende stabilisierte zubereitungen |
| US20030138417A1 (en) | 2001-11-08 | 2003-07-24 | Kaisheva Elizabet A. | Stable liquid pharmaceutical formulation of IgG antibodies |
| DE10163459A1 (de) * | 2001-12-21 | 2003-07-03 | Merck Patent Gmbh | Lyophilisierte Zubereitung enthaltend Antikörper gegen EGF-Rezeptor |
| DE10204792A1 (de) * | 2002-02-06 | 2003-08-14 | Merck Patent Gmbh | Lyophilisierte Zubereitung enthaltend Immuncytokine |
| WO2003068259A1 (fr) * | 2002-02-14 | 2003-08-21 | Chugai Seiyaku Kabushiki Kaisha | Produits pharmaceutiques en solution contenant des anticorps |
| US20030180287A1 (en) | 2002-02-27 | 2003-09-25 | Immunex Corporation | Polypeptide formulation |
| US20040033228A1 (en) * | 2002-08-16 | 2004-02-19 | Hans-Juergen Krause | Formulation of human antibodies for treating TNF-alpha associated disorders |
| WO2004028557A1 (ja) * | 2002-09-26 | 2004-04-08 | Shionogi & Co., Ltd. | 安定化されたタンパク組成物 |
| JPWO2004033499A1 (ja) | 2002-10-11 | 2006-02-09 | 中外製薬株式会社 | 細胞死誘導剤 |
| ZA200506159B (en) | 2003-02-10 | 2006-10-25 | Elan Pharm Inc | Immunoglobulin formulation and method of preparation thereof |
| AU2004216298B2 (en) | 2003-02-28 | 2009-04-23 | Chugai Seiyaku Kabushiki Kaisha | Stabilized protein-containing formulations |
| DK1610820T4 (da) | 2003-04-04 | 2013-11-04 | Genentech Inc | Høj-koncentration antistof- og proteinformuleringer |
| PL1684719T3 (pl) * | 2003-11-14 | 2012-11-30 | Baxalta Inc | Kompozycje alfa 1-antytrypsyny i sposoby leczenia z zastosowaniem takich kompozycji |
| EP1532983A1 (en) * | 2003-11-18 | 2005-05-25 | ZLB Bioplasma AG | Immunoglobulin preparations having increased stability |
| DE10355251A1 (de) * | 2003-11-26 | 2005-06-23 | Merck Patent Gmbh | Pharmazeutische Zubereitung enthaltend einen Antikörper gegen den EGF-Rezeptor |
| DE10355904A1 (de) | 2003-11-29 | 2005-06-30 | Merck Patent Gmbh | Feste Formen von anti-EGFR-Antikörpern |
| WO2005056603A1 (ja) * | 2003-12-12 | 2005-06-23 | Chugai Seiyaku Kabushiki Kaisha | 細胞死誘導剤 |
| WO2005056602A1 (ja) * | 2003-12-12 | 2005-06-23 | Chugai Seiyaku Kabushiki Kaisha | アゴニスト活性を有する改変抗体のスクリーニング方法 |
| TW200530269A (en) | 2003-12-12 | 2005-09-16 | Chugai Pharmaceutical Co Ltd | Anti-Mpl antibodies |
| US20080274110A1 (en) * | 2004-04-09 | 2008-11-06 | Shuji Ozaki | Cell Death-Inducing Agents |
| KR100624013B1 (ko) * | 2004-06-25 | 2006-09-19 | 주식회사 녹십자홀딩스 | 동결건조된 알부민 비함유 재조합 사람 혈액응고 제 8인자 제제 |
| JP2007277094A (ja) * | 2004-06-29 | 2007-10-25 | Chemo Sero Therapeut Res Inst | 改変ダニ主要アレルゲン含有医薬組成物 |
| AU2005287404B2 (en) | 2004-07-22 | 2009-05-07 | Genentech, Inc. | HER2 antibody composition |
| TW200621282A (en) | 2004-08-13 | 2006-07-01 | Wyeth Corp | Stabilizing formulations |
| RU2007114068A (ru) * | 2004-09-15 | 2008-10-27 | Оцука Фармасьютикал Ко. | Композиция для введения через слизистую оболочку и способ улучшения всасывания через слизистую оболочку |
| JO3000B1 (ar) | 2004-10-20 | 2016-09-05 | Genentech Inc | مركبات أجسام مضادة . |
| MX2007008768A (es) * | 2005-01-21 | 2007-10-19 | Genentech Inc | Dosificacion fija de anticuerpos her. |
| CN1313161C (zh) * | 2005-01-27 | 2007-05-02 | 北京大学临床肿瘤学院 | 结直肠癌放射免疫导向手术药物及其制备方法 |
| CN103251946A (zh) * | 2005-02-23 | 2013-08-21 | 健泰科生物技术公司 | 使用her二聚化抑制剂在癌症患者中延长病情进展前时间或存活 |
| US9493569B2 (en) | 2005-03-31 | 2016-11-15 | Chugai Seiyaku Kabushiki Kaisha | Structural isomers of sc(Fv)2 |
| KR101360671B1 (ko) | 2005-06-10 | 2014-02-07 | 추가이 세이야쿠 가부시키가이샤 | ｓｃ（Ｆｖ）２를 함유하는 의약조성물 |
| EP1908482B1 (en) * | 2005-06-10 | 2017-09-06 | Chugai Seiyaku Kabushiki Kaisha | Stabilizer for protein preparation comprising meglumine and use thereof |
| EP1909831A4 (en) | 2005-06-14 | 2013-02-20 | Amgen Inc | SELF-BUFFING PROTEIN FORMULATIONS |
| AU2007212147A1 (en) * | 2006-02-03 | 2007-08-16 | Medimmune, Llc | Protein formulations |
| AU2013224728B2 (en) * | 2006-02-07 | 2016-10-20 | Takeda Pharmaceutical Company Limited | Stabilized Compositions of Proteins Having a Free Thiol Moiety |
| JP5364382B2 (ja) | 2006-02-07 | 2013-12-11 | シャイアー ヒューマン ジェネティック セラピーズ インコーポレイテッド | 遊離チオール部分を有するタンパク質の安定化された組成物 |
| CN101495136A (zh) * | 2006-02-15 | 2009-07-29 | 英克隆系统公司 | 抗体配制品 |
| US7846724B2 (en) | 2006-04-11 | 2010-12-07 | Hoffmann-La Roche Inc. | Method for selecting CHO cell for production of glycosylated antibodies |
| TW200808351A (en) * | 2006-07-13 | 2008-02-16 | Chugai Pharmaceutical Co Ltd | Cell death-inducing agents |
| WO2008029908A1 (fr) * | 2006-09-07 | 2008-03-13 | Kyowa Hakko Kirin Co., Ltd. | Préparation pharmaceutique lyophilisée stable comprenant un anticorps |
| PE20090681A1 (es) | 2007-03-02 | 2009-06-10 | Genentech Inc | Prediccion de respuesta a un inhibidor her |
| CA2692165A1 (en) * | 2007-06-25 | 2008-12-31 | Amgen Inc. | Compositions of specific binding agents to hepatocyte growth factor |
| JOP20080381B1 (ar) | 2007-08-23 | 2023-03-28 | Amgen Inc | بروتينات مرتبطة بمولدات مضادات تتفاعل مع بروبروتين كونفيرتاز سيتيليزين ككسين من النوع 9 (pcsk9) |
| US9308257B2 (en) | 2007-11-28 | 2016-04-12 | Medimmune, Llc | Protein formulation |
| KR20090056543A (ko) * | 2007-11-30 | 2009-06-03 | 주식회사 녹십자 | Ｂ형 간염 바이러스(ｈｂｖ) 중화 인간 항체를 포함하는약학적 제제 |
| US8883146B2 (en) | 2007-11-30 | 2014-11-11 | Abbvie Inc. | Protein formulations and methods of making same |
| TWI472339B (zh) | 2008-01-30 | 2015-02-11 | Genentech Inc | 包含結合至ｈｅｒ２結構域ii之抗體及其酸性變異體的組合物 |
| BRPI0812682A2 (pt) | 2008-06-16 | 2010-06-22 | Genentech Inc | tratamento de cáncer de mama metastático |
| 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). |
| US20130064834A1 (en) | 2008-12-15 | 2013-03-14 | Regeneron Pharmaceuticals, Inc. | Methods for treating hypercholesterolemia using antibodies to pcsk9 |
| WO2010100200A2 (en) * | 2009-03-05 | 2010-09-10 | Novartis Ag | Lyophilised antibody formulation |
| CA2754528A1 (en) | 2009-03-06 | 2010-09-10 | Genetech, Inc. | Antibody formulation |
| PL3354277T3 (pl) | 2009-07-28 | 2021-12-13 | Takeda Pharmaceutical Company Limited | Kompozycje i sposoby leczenia choroby gauchera |
| US9345661B2 (en) | 2009-07-31 | 2016-05-24 | Genentech, Inc. | Subcutaneous anti-HER2 antibody formulations and uses thereof |
| US8852954B2 (en) | 2009-08-21 | 2014-10-07 | Nec Solution Innovators, Ltd. | Nucleic acid molecule having binding affinity to rodent-derived IgG antibody, binder, detection reagent, and detection kit |
| AR078161A1 (es) | 2009-09-11 | 2011-10-19 | Hoffmann La Roche | Formulaciones farmaceuticas muy concentradas de un anticuerpo anti cd20. uso de la formulacion. metodo de tratamiento. |
| HUE033758T2 (en) | 2009-10-26 | 2017-12-28 | Hoffmann La Roche | A method for producing glycosylated immunoglobulin |
| AU2011212440B2 (en) | 2010-02-04 | 2015-01-22 | 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 |
| SG183443A1 (en) | 2010-03-01 | 2012-09-27 | Bayer Healthcare Llc | Optimized monoclonal antibodies against tissue factor pathway inhibitor (tfpi) |
| CN103108658B (zh) * | 2010-07-02 | 2015-08-19 | 米迪缪尼有限公司 | 抗体制剂 |
| WO2012028683A1 (en) | 2010-09-02 | 2012-03-08 | Novartis Ag | Antibody gel system for sustained drug delivery |
| EP2627318B1 (en) * | 2010-10-12 | 2017-08-16 | Merz Pharma GmbH & Co. KGaA | Formulation suitable for stabilizing proteins, which is free of mammalian excipients |
| HRP20251174T1 (hr) | 2010-11-05 | 2025-11-21 | Novartis Ag | Postupci za liječenje psorijatičnog artritisa uporabom il-17 antagonista |
| MX344727B (es) | 2010-11-11 | 2017-01-05 | Abbvie Biotechnology Ltd | Formulaciones liquidas de anticuerpos anti-tnf-alfa de alta concentracion mejoradas. |
| HRP20180959T1 (hr) | 2011-01-28 | 2018-07-27 | Sanofi Biotechnology | Ljudska protutijela za pcsk9 za uporabu u postupcima liječenja određenih skupina subjekata |
| ES2734076T3 (es) | 2011-02-17 | 2019-12-04 | Kyowa Hakko Kirin Co Ltd | Preparación farmacéutica de anticuerpo anti-CD40 muy concentrada |
| US9220776B2 (en) * | 2011-03-31 | 2015-12-29 | Merck Sharp & Dohme Corp. | Stable formulations of antibodies to human programmed death receptor PD-1 and related treatments |
| JP6024025B2 (ja) * | 2011-05-02 | 2016-11-09 | イミューノメディクス、インコーポレイテッドＩｍｍｕｎｏｍｅｄｉｃｓ， Ｉｎｃ． | 少容量投与用のアロタイプ選択抗体の限外濾過濃縮 |
| UA116189C2 (uk) * | 2011-05-02 | 2018-02-26 | Мілленніум Фармасьютікалз, Інк. | КОМПОЗИЦІЯ АНТИ-α4β7 АНТИТІЛА |
| 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) |
| DK4403228T3 (da) | 2011-10-14 | 2025-10-13 | Hoffmann La Roche | Anvendelser for og fremstillet artikel indbefattende HER2-dimeriseringshæmmeren pertuzumab |
| US10485869B2 (en) | 2011-10-18 | 2019-11-26 | Coherus Biosciences, Inc. | Etanercept formulations stabilized with meglumine |
| BR112014009031A2 (pt) | 2011-10-18 | 2017-05-09 | Coherus Biosciences Inc | formulações de etanercept estabilizadas com íons de metais |
| SG11201401360XA (en) | 2011-10-25 | 2014-05-29 | Onclave Therapeutics Ltd | Antibody formulations and methods |
| MY164611A (en) | 2012-01-23 | 2018-01-30 | Regeneron Pharma | Stabilized formulations containing anti-ang2 antibodies |
| HK1207005A1 (en) | 2012-03-02 | 2016-01-22 | 夏尔人类遗传性治疗公司 | Compositions and methods for treating type iii gaucher disease |
| SG11201405475UA (en) * | 2012-03-07 | 2014-10-30 | Cadila Healthcare Ltd | Pharmaceutical formulations of tnf-alpha antibodies |
| AR092325A1 (es) | 2012-05-31 | 2015-04-15 | Regeneron Pharma | Formulaciones estabilizadas que contienen anticuerpos anti-dll4 y kit |
| MX2015000337A (es) | 2012-07-09 | 2015-09-25 | Coherus Biosciences Inc | Formulaciones de etanercept que exhiben reduccion notable en particulas subvisibles. |
| US9592297B2 (en) | 2012-08-31 | 2017-03-14 | Bayer Healthcare Llc | Antibody and protein formulations |
| US8883979B2 (en) | 2012-08-31 | 2014-11-11 | Bayer Healthcare Llc | Anti-prolactin receptor antibody formulations |
| US8613919B1 (en) | 2012-08-31 | 2013-12-24 | Bayer Healthcare, Llc | High concentration antibody and protein formulations |
| MX2015003007A (es) | 2012-09-07 | 2015-06-05 | Coherus Biosciences Inc | Formulaciones acuosas estables de adalimumab. |
| LT2895188T (lt) | 2012-09-11 | 2018-04-10 | Coherus Biosciences, Inc. | Aukšto grynumo ir geros išeigos teisingos struktūros etanerceptas |
| 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 |
| RU2737727C2 (ru) | 2013-04-16 | 2020-12-02 | Дженентек, Инк. | Варианты пертузумаба и их аналитическая характеристика |
| 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) |
| CN111920954A (zh) | 2013-06-07 | 2020-11-13 | 再生元制药公司 | 通过施用pcsk9抑制剂抑制动脉粥样硬化的方法 |
| 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 |
| RU2020120593A (ru) | 2014-04-25 | 2020-09-01 | Дженентек, Инк. | Способы лечения раннего рака молочной железы трастузумабом-mcc-dm1 и пертузумабом |
| IS3008B (is) * | 2014-05-14 | 2018-12-15 | Calor ehf | Stöðgandi lausnir fyrir prótín og peptíð |
| KR20170029613A (ko) | 2014-07-16 | 2017-03-15 | 사노피 바이오테크놀로지 | 이형접합성 가족성 고콜레스테롤혈증(heFH) 환자의 치료방법 |
| US9821059B2 (en) * | 2014-10-17 | 2017-11-21 | Alteogen Inc. | Composition for stabilizing protein and pharmaceutical formulation comprising the same |
| CA2968915A1 (en) | 2014-12-03 | 2016-06-09 | Csl Behring Ag | Pharmaceutical product with increased stability comprising immunoglobulins |
| US10172942B2 (en) | 2014-12-17 | 2019-01-08 | Pfizer Inc. | Formulations of a PI3K/mTor-inhibitor for intravenous administration |
| AR103173A1 (es) | 2014-12-22 | 2017-04-19 | Novarits Ag | Productos farmacéuticos y composiciones líquidas estables de anticuerpos il-17 |
| WO2016167263A1 (ja) | 2015-04-14 | 2016-10-20 | 中外製薬株式会社 | Ｉｌ－３１アンタゴニストを有効成分として含有する、アトピー性皮膚炎の予防用及び／又は治療用医薬組成物 |
| ES3036076T3 (en) | 2015-04-14 | 2025-09-12 | Chugai Pharmaceutical Co Ltd | Pharmaceutical composition for prevention and/or treatment of atopic dermatitis containing il-31 antagonist as active ingredient |
| EP3287140B1 (en) | 2015-04-21 | 2021-06-02 | Staidson (Beijing) Biopharmaceuticals Co., Ltd. | Nerve growth factor composition and powder injection |
| ES2984592T3 (es) | 2015-05-30 | 2024-10-30 | Hoffmann La Roche | Procedimientos de tratamiento de cáncer de mama metastásico no tratado previamente positivo para HER2 |
| IL314925A (en) | 2015-08-18 | 2024-10-01 | Regeneron Pharma | Antibodies against PCSK9 for the treatment of patients with hyperlipidemia undergoing lipoprotein-lowering therapy |
| US11229702B1 (en) | 2015-10-28 | 2022-01-25 | Coherus Biosciences, Inc. | High concentration formulations of adalimumab |
| WO2017087280A1 (en) | 2015-11-16 | 2017-05-26 | Genentech, Inc. | Methods of treating her2-positive cancer |
| EP3391904B1 (en) * | 2015-12-18 | 2024-12-04 | Upstream Bio, Inc. | Pharmaceutical composition containing anti-human tslp receptor antibody |
| WO2017184880A1 (en) | 2016-04-20 | 2017-10-26 | Coherus Biosciences, Inc. | A method of filling a container with no headspace |
| ES2968923T3 (es) | 2016-08-10 | 2024-05-14 | Celltrion Inc | Preparación farmacéutica líquida estable de anticuerpo contra el virus de la gripe |
| US11351256B2 (en) | 2016-10-07 | 2022-06-07 | Regeneron Pharmaceuticals, Inc. | Room temperature stable lyophilized protein |
| AU2017345490B2 (en) | 2016-10-21 | 2022-07-07 | Amgen Inc. | Pharmaceutical formulations and methods of making the same |
| TW202508629A (zh) | 2017-01-17 | 2025-03-01 | 美商建南德克公司 | 皮下her2抗體調配物 |
| KR20230144110A (ko) | 2017-03-02 | 2023-10-13 | 제넨테크, 인크. | Her2-양성 유방암 어쥬번트 치료 |
| MX2020001885A (es) * | 2017-08-31 | 2020-09-07 | Xellia Pharmaceuticals Aps | Formulaciones de daptomicina. |
| WO2020168338A1 (en) | 2019-02-15 | 2020-08-20 | The Regents Of The University Of California | Methods for converting colloidal systems to resuspendable/redispersible powders that preserve the original properties of the colloids |
| CN112206320B (zh) * | 2019-07-12 | 2025-02-25 | 鲁南制药集团股份有限公司 | 一种cd47单克隆抗体冻干粉制剂及其制备工艺 |
| CN112516301B (zh) * | 2019-09-17 | 2025-03-18 | 鲁南制药集团股份有限公司 | 一种cd47单克隆抗体的液体制剂及其制备方法 |
| BR112022006590A2 (pt) * | 2019-11-20 | 2022-06-28 | Chugai Pharmaceutical Co Ltd | Preparação contendo anticorpos |
| JP2023532122A (ja) | 2020-06-29 | 2023-07-26 | ジェネンテック， インコーポレイテッド | ペルツズマブにトラスツズマブを加えた固定用量配合剤 |
| WO2024102675A1 (en) | 2022-11-07 | 2024-05-16 | Upstream Bio, Inc. | Pharmaceutical compositions comprising anti-human tslp receptor antibodies and methods of using the same |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1993005799A1 (en) * | 1991-09-24 | 1993-04-01 | Farmitalia Carlo Erba S.R.L. | Lyophilized stable pharmaceutical compositions containing a granulocyte macrophage colony stimulating factor |
Family Cites Families (42)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4016043A (en) * | 1975-09-04 | 1977-04-05 | Akzona Incorporated | Enzymatic immunological method for the determination of antigens and antibodies |
| US4165370A (en) * | 1976-05-21 | 1979-08-21 | Coval M L | Injectable gamma globulin |
| JPS56113713A (en) | 1980-02-14 | 1981-09-07 | Chemo Sero Therapeut Res Inst | Preparation of immunoglobulin with high content of monomer |
| US4439421A (en) | 1982-08-30 | 1984-03-27 | Baxter Travenol Laboratories, Inc. | Stabilized gamma globulin concentrate |
| JPS60146833A (ja) | 1984-01-10 | 1985-08-02 | Green Cross Corp:The | モノクロ−ナル抗体製剤 |
| US4650772A (en) | 1984-08-09 | 1987-03-17 | Abbott Laboratories | Monoclonal antibody stabilization |
| US4597966A (en) | 1985-01-09 | 1986-07-01 | Ortho Diagnostic Systems, Inc. | Histidine stabilized immunoglobulin and method of preparation |
| JPH0825902B2 (ja) | 1985-02-21 | 1996-03-13 | 株式会社ミドリ十字 | γ−グロブリンの加熱処理方法 |
| JPS6388197A (ja) | 1986-09-30 | 1988-04-19 | Tosoh Corp | モノクロナル抗体の安定化方法 |
| ATE83930T1 (de) | 1987-02-20 | 1993-01-15 | Akzo Nv | Antikoerper enthaltende stabilisierte waesserige zusammensetzung. |
| AU600575B2 (en) | 1987-03-18 | 1990-08-16 | Sb2, Inc. | Altered antibodies |
| ATE82136T1 (de) | 1987-08-10 | 1992-11-15 | Miles Inc | Gereinigtes igm. |
| JPS6475433A (en) | 1987-09-16 | 1989-03-22 | Teijin Ltd | Remedy for herpes simplex virus infection |
| WO1989007945A1 (en) | 1988-02-26 | 1989-09-08 | Genentech, Inc. | Human relaxin formulation |
| US5096885A (en) | 1988-04-15 | 1992-03-17 | Genentech, Inc. | Human growth hormone formulation |
| JPH03504499A (ja) | 1988-05-27 | 1991-10-03 | セントカー・インコーポレーテツド | 抗体試薬のための配合物 |
| WO1989011297A1 (en) | 1988-05-27 | 1989-11-30 | Centocor, Inc. | Freeze-dried formulation for antibody products |
| DE3825429C2 (de) | 1988-07-27 | 1994-02-10 | Biotest Pharma Gmbh | Verfahren zur Herstellung eines intravenös verabreichbaren polyklonalen Immunglobulin-Präparates mit hohem IgM-Gehalt |
| US5468468A (en) * | 1989-02-09 | 1995-11-21 | The United States Of America, As Represented By The Secretary Of The Department Of Health & Human Services | Method for making a monoclonal antibody, monoclonal antibodies to α PD |
| DE3927111C3 (de) | 1989-08-17 | 1994-09-01 | Biotest Pharma Gmbh | Verfahren zur Herstellung nicht modifizierter intravenös verabreichbarer IgM- und/oderIgA-haltiger Immunglobulinpräparate |
| GB9015824D0 (en) | 1990-07-18 | 1990-09-05 | Erba Carlo Spa | Stable pharmaceutical compositions containing a fibroblast growth factor |
| JPH0565233A (ja) | 1991-03-08 | 1993-03-19 | Mitsui Toatsu Chem Inc | モノクローナル抗体含有凍結乾燥製剤 |
| US5440021A (en) | 1991-03-29 | 1995-08-08 | Chuntharapai; Anan | Antibodies to human IL-8 type B receptor |
| WO1993000807A1 (en) | 1991-07-03 | 1993-01-21 | Cryolife, Inc. | Method for stabilization of biomaterials |
| JP2966592B2 (ja) | 1991-07-20 | 1999-10-25 | 萩原 義秀 | 安定化されたヒトモノクローナル抗体製剤 |
| IL101007A (en) | 1992-02-18 | 1997-08-14 | Pharmos Ltd | Dry stable compositions prepared by lyophilization |
| US5639641A (en) | 1992-09-09 | 1997-06-17 | Immunogen Inc. | Resurfacing of rodent antibodies |
| ATE316981T1 (de) | 1992-10-02 | 2006-02-15 | Inst Genetics Llc | Zusammensetzung, welche den koagulationsfaktor viii beinhalted; verfahren zu deren herstellung und die benutzung eines oberflächenaktiven stoffes als stabilisator |
| AU684455B2 (en) | 1992-11-06 | 1997-12-18 | Sandoz Ltd. | Production of human monoclonal antibodies active against hepatitis B surface antigen |
| JPH08503617A (ja) | 1992-12-01 | 1996-04-23 | プロテイン デザイン ラブズ、インコーポレーテッド | Ｌ−セレクチンに反応性のヒト化抗体 |
| DE4242863A1 (de) | 1992-12-18 | 1994-06-23 | Boehringer Mannheim Gmbh | Stabile lyophilisierte pharmazeutische Zubereitungen von G-CSF |
| US5385887A (en) * | 1993-09-10 | 1995-01-31 | Genetics Institute, Inc. | Formulations for delivery of osteogenic proteins |
| CA2156255C (en) * | 1993-12-17 | 2008-02-05 | Yasuyuki Kunihiro | Soluble thrombomodulin-containing composition |
| DE4344824C1 (de) * | 1993-12-28 | 1995-08-31 | Immuno Ag | Hochkonzentriertes Immunglobulin-Präparat und Verfahren zu seiner Herstellung |
| FR2719479B1 (fr) * | 1994-05-04 | 1996-07-26 | Sanofi Elf | Formulation stable lyophilisée comprenant une protéine: kit de dosage. |
| EP0795608B1 (en) | 1994-11-30 | 2003-04-09 | Ajinomoto Co., Inc. | Antithrombotic agent and anti-von willebrand factor monoclonal antibodies |
| DE69605181T3 (de) | 1995-01-18 | 2006-08-24 | Roche Diagnostics Gmbh | Antikörper gegen cd30, die proteolytische spaltung und abgabe des membrangebundenen cd30 antigens verhindern |
| DE19508192A1 (de) * | 1995-03-09 | 1996-09-12 | Behringwerke Ag | Stabile Transglutaminasepräparate und Verfahren zu ihrer Herstellung |
| MX9800684A (es) * | 1995-07-27 | 1998-04-30 | Genentech Inc | Formulacion de proteinas liofilizadas isotonicas estables. |
| US6267958B1 (en) * | 1995-07-27 | 2001-07-31 | Genentech, Inc. | Protein formulation |
| DE19539574A1 (de) * | 1995-10-25 | 1997-04-30 | Boehringer Mannheim Gmbh | Zubereitungen und Verfahren zur Stabilisierung biologischer Materialien mittels Trocknungsverfahren ohne Einfrieren |
| EP0852951A1 (de) * | 1996-11-19 | 1998-07-15 | Roche Diagnostics GmbH | Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern |
-
1996
- 1996-11-19 EP EP96118489A patent/EP0852951A1/de not_active Withdrawn
-
1997
- 1997-11-19 ZA ZA9710409A patent/ZA9710409B/xx unknown
- 1997-11-19 BR BR9713521A patent/BR9713521A/pt not_active Application Discontinuation
- 1997-11-19 ID IDP973713A patent/ID19029A/id unknown
- 1997-11-19 DK DK97951238T patent/DK0941121T3/da active
- 1997-11-19 DE DE59711959T patent/DE59711959D1/de not_active Expired - Lifetime
- 1997-11-19 EP EP97951238A patent/EP0941121B1/de not_active Revoked
- 1997-11-19 AT AT97951238T patent/ATE276762T1/de active
- 1997-11-19 JP JP52321098A patent/JP4536829B2/ja not_active Expired - Lifetime
- 1997-11-19 CA CA2272245A patent/CA2272245C/en not_active Expired - Lifetime
- 1997-11-19 WO PCT/EP1997/006452 patent/WO1998022136A2/de not_active Ceased
- 1997-11-19 ES ES97951238T patent/ES2227727T3/es not_active Expired - Lifetime
- 1997-11-19 TR TR1999/01696T patent/TR199901696T2/xx unknown
- 1997-11-19 TW TW086117416A patent/TW520291B/zh active
- 1997-11-19 AR ARP970105404A patent/AR012540A1/es active IP Right Grant
- 1997-11-19 AU AU54841/98A patent/AU735411C/en not_active Expired
- 1997-11-19 CN CNB971814163A patent/CN1155408C/zh not_active Ceased
- 1997-11-19 PT PT97951238T patent/PT941121E/pt unknown
- 1997-11-19 KR KR10-1999-7004336A patent/KR100514207B1/ko not_active Expired - Lifetime
-
2001
- 2001-10-05 AU AU78242/01A patent/AU772940B2/en not_active Expired
-
2008
- 2008-07-28 US US12/180,794 patent/US8758747B2/en not_active Expired - Fee Related
- 2008-09-11 JP JP2008233138A patent/JP5153532B2/ja not_active Expired - Lifetime
-
2009
- 2009-12-30 AR ARP090105181A patent/AR074958A2/es not_active Application Discontinuation
-
2014
- 2014-05-12 US US14/275,140 patent/US20140248274A1/en not_active Abandoned
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1993005799A1 (en) * | 1991-09-24 | 1993-04-01 | Farmitalia Carlo Erba S.R.L. | Lyophilized stable pharmaceutical compositions containing a granulocyte macrophage colony stimulating factor |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR101280273B1 (ko) | 2005-04-18 | 2013-07-15 | 예다 리서치 앤드 디벨럽먼트 캄파니 리미티드 | 안정화된 항-ｂ형 간염 바이러스 (ｈｂｖ) 항체 제형 |
Also Published As
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| US8758747B2 (en) | 2014-06-24 |
| AU7824201A (en) | 2001-11-22 |
| CA2272245C (en) | 2013-09-10 |
| US20080286280A1 (en) | 2008-11-20 |
| EP0941121B1 (de) | 2004-09-22 |
| CA2272245A1 (en) | 1998-05-28 |
| AU772940B2 (en) | 2004-05-13 |
| JP2009046494A (ja) | 2009-03-05 |
| ZA9710409B (en) | 1999-05-19 |
| JP4536829B2 (ja) | 2010-09-01 |
| US20140248274A1 (en) | 2014-09-04 |
| DK0941121T3 (da) | 2005-01-31 |
| AR074958A2 (es) | 2011-02-23 |
| EP0941121A2 (de) | 1999-09-15 |
| EP0852951A1 (de) | 1998-07-15 |
| JP2001503781A (ja) | 2001-03-21 |
| WO1998022136A3 (de) | 1998-08-20 |
| TR199901696T2 (xx) | 1999-09-21 |
| KR20000053328A (ko) | 2000-08-25 |
| ES2227727T3 (es) | 2005-04-01 |
| CN1244805A (zh) | 2000-02-16 |
| ATE276762T1 (de) | 2004-10-15 |
| AU735411B2 (en) | 2001-07-05 |
| JP5153532B2 (ja) | 2013-02-27 |
| DE59711959D1 (de) | 2004-10-28 |
| PT941121E (pt) | 2005-01-31 |
| TW520291B (en) | 2003-02-11 |
| AR012540A1 (es) | 2000-11-08 |
| BR9713521A (enExample) | 2000-03-21 |
| AU5484198A (en) | 1998-06-10 |
| ID19029A (id) | 1998-06-04 |
| CN1155408C (zh) | 2004-06-30 |
| AU735411C (en) | 2004-08-05 |
| WO1998022136A2 (de) | 1998-05-28 |
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