ECSP099837A - Formulaciones de inmunoglobulina liofilizadas y métodos para su preparación - Google Patents
Formulaciones de inmunoglobulina liofilizadas y métodos para su preparaciónInfo
- Publication number
- ECSP099837A ECSP099837A EC2009009837A ECSP099837A ECSP099837A EC SP099837 A ECSP099837 A EC SP099837A EC 2009009837 A EC2009009837 A EC 2009009837A EC SP099837 A ECSP099837 A EC SP099837A EC SP099837 A ECSP099837 A EC SP099837A
- Authority
- EC
- Ecuador
- Prior art keywords
- formulations
- liofilized
- immunoglobulin
- preparation
- methods
- Prior art date
Links
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
- A61K39/39591—Stabilisation, fragmentation
-
- 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
-
- 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
- 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
- C07K16/2839—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 integrin superfamily
-
- 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
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
-
- 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)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Genetics & Genomics (AREA)
- Mycology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Microbiology (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Abstract
La presente invención se refiere en general al cambio de la formulación farmacéutica de inmunoglobulinas. Específicamente, la presente invención se refiere a formulaciones de inmunoglobulina estables, liofilizadas y de alta concentración. Esta invención se ejemplifica con una formulación liofilizada estabilizada del anticuerpo contra la integrina alfa 4 humanizado recombinante natalizumab
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US92913307P | 2007-06-14 | 2007-06-14 | |
US12/138,075 US20090208492A1 (en) | 2007-06-14 | 2008-06-12 | Lyophilized Immunoglobulin Formulations and Methods of Preparation |
Publications (1)
Publication Number | Publication Date |
---|---|
ECSP099837A true ECSP099837A (es) | 2010-01-29 |
Family
ID=40156638
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EC2009009837A ECSP099837A (es) | 2007-06-14 | 2009-12-30 | Formulaciones de inmunoglobulina liofilizadas y métodos para su preparación |
Country Status (15)
Country | Link |
---|---|
US (1) | US20090208492A1 (es) |
EP (1) | EP2167126A4 (es) |
JP (1) | JP2010530003A (es) |
KR (1) | KR20100038100A (es) |
CN (1) | CN101827608A (es) |
AU (1) | AU2008265930A1 (es) |
BR (1) | BRPI0812561A2 (es) |
CA (1) | CA2691855A1 (es) |
CO (1) | CO6251275A2 (es) |
EA (1) | EA201000018A1 (es) |
EC (1) | ECSP099837A (es) |
IL (1) | IL202660A0 (es) |
MA (1) | MA31519B1 (es) |
MX (1) | MX2009013558A (es) |
WO (1) | WO2008157409A1 (es) |
Families Citing this family (30)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
AU2006270165B2 (en) | 2005-07-14 | 2010-03-11 | Neothetics, Inc. | Sustained release enhanced lipolytic formulation for regional adipose tissue treatment |
MY159517A (en) | 2008-03-14 | 2017-01-13 | Biocon Ltd | A monoclonal antibody and a method thereof |
US9132084B2 (en) | 2009-05-27 | 2015-09-15 | Neothetics, Inc. | Methods for administration and formulations for the treatment of regional adipose tissue |
JP2012530721A (ja) * | 2009-06-18 | 2012-12-06 | ワイス・エルエルシー | 小モジュール免疫薬のための凍結乾燥製剤 |
MY165614A (en) * | 2009-11-20 | 2018-04-18 | Biocon Ltd | Formulations of antibody |
CN102869363A (zh) * | 2010-01-15 | 2013-01-09 | 利赛拉公司 | 冻干的块状制剂 |
JP2013520476A (ja) * | 2010-02-26 | 2013-06-06 | ノヴォ ノルディスク アー/エス | 安定な抗体含有組成物 |
US9072668B2 (en) | 2010-03-09 | 2015-07-07 | Janssen Biotech, Inc. | Non-aqueous high concentration reduced viscosity suspension formulations of antibodies |
US20110223208A1 (en) * | 2010-03-09 | 2011-09-15 | Beth Hill | Non-Aqueous High Concentration Reduced Viscosity Suspension Formulations |
WO2011147921A1 (en) | 2010-05-28 | 2011-12-01 | Novo Nordisk A/S | Stable multi-dose compositions comprising an antibody and a preservative |
AU2011301803A1 (en) * | 2010-09-17 | 2013-03-21 | Baxalta GmbH | Stabilization of immunoglobulins and other proteins through aqueous formulations with sodium chloride at weak acidic to neutral pH |
SG190878A1 (en) | 2010-11-24 | 2013-07-31 | Lithera Inc | Selective, lipophilic, and long-acting beta agonist monotherapeutic formulations and methods for the cosmetic treatment of adiposity and contour bulging |
KR102031020B1 (ko) * | 2011-03-31 | 2019-10-14 | 머크 샤프 앤드 돔 코포레이션 | 인간 프로그램화된 사멸 수용체 pd-1에 대한 항체의 안정한 제제 및 관련된 치료 |
US9592289B2 (en) | 2012-03-26 | 2017-03-14 | Sanofi | Stable IgG4 based binding agent formulations |
CA2868401C (en) * | 2012-03-26 | 2021-08-24 | Sanofi | Stable anti-cxcr5 igg4 antibody formulations |
UA117466C2 (uk) | 2012-12-13 | 2018-08-10 | Мерк Шарп Енд Доме Корп. | СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19 |
JP6407174B2 (ja) | 2013-03-15 | 2018-10-17 | タケダ ゲー・エム・ベー・ハーTakeda GmbH | 抗体の配合物および該配合物の使用 |
WO2015011658A1 (en) | 2013-07-23 | 2015-01-29 | Biocon Limited | Use of a cd6 binding partner and method based thereon |
US20210322549A1 (en) * | 2015-07-17 | 2021-10-21 | Coherus Biosciences, Inc. | Stable Aqueous Formulations of Natalizumab |
US10966929B2 (en) | 2015-09-07 | 2021-04-06 | Mochida Pharmaceutical Co., Ltd. | Freeze-dried alginic acid preparation |
JP2019534263A (ja) * | 2016-10-07 | 2019-11-28 | リジェネロン・ファーマシューティカルズ・インコーポレイテッドRegeneron Pharmaceuticals, Inc. | 室温で安定な凍結乾燥タンパク質 |
AU2017344462A1 (en) | 2016-10-21 | 2019-05-02 | Biocon Limited | A monoclonal antibody and a method of use for the treatment of lupus |
RU2019138507A (ru) | 2017-05-02 | 2021-06-02 | Мерк Шарп И Доум Корп. | Составы антител против lag3 и совместные составы антител против lag3 и антител против pd-1 |
JOP20190260A1 (ar) | 2017-05-02 | 2019-10-31 | Merck Sharp & Dohme | صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها |
JP2021521171A (ja) * | 2018-04-10 | 2021-08-26 | ドクター レディズ ラボラトリーズ リミテッド | 治療用抗体の安定な製剤 |
US20210147555A1 (en) * | 2018-04-10 | 2021-05-20 | Dr. Reddy?s Laboratories Limited | Antibody formulation |
JP2021521168A (ja) * | 2018-04-10 | 2021-08-26 | ドクター レディズ ラボラトリーズ リミテッド | 安定な抗体製剤 |
JP2022532965A (ja) * | 2018-11-21 | 2022-07-21 | リジェネロン・ファーマシューティカルズ・インコーポレイテッド | 高濃度タンパク質製剤 |
EP3927729A4 (en) | 2019-02-18 | 2023-10-11 | Eli Lilly and Company | THERAPEUTIC ANTIBODY FORMULATION |
CN112538111B (zh) * | 2020-12-09 | 2022-04-29 | 深圳市亚辉龙生物科技股份有限公司 | 新冠病毒单链抗体及质控品和制备方法 |
Family Cites Families (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6306404B1 (en) * | 1998-07-14 | 2001-10-23 | American Cyanamid Company | Adjuvant and vaccine compositions containing monophosphoryl lipid A |
JP4317010B2 (ja) * | 2001-07-25 | 2009-08-19 | ピーディーエル バイオファーマ,インコーポレイティド | IgG抗体の安定な凍結乾燥医薬製剤 |
CN103040732B (zh) * | 2003-02-10 | 2015-04-01 | 伊兰药品公司 | 免疫球蛋白制剂及其制备方法 |
US20060008415A1 (en) * | 2004-06-25 | 2006-01-12 | Protein Design Labs, Inc. | Stable liquid and lyophilized formulation of proteins |
-
2008
- 2008-06-12 US US12/138,075 patent/US20090208492A1/en not_active Abandoned
- 2008-06-13 BR BRPI0812561-9A2A patent/BRPI0812561A2/pt not_active IP Right Cessation
- 2008-06-13 CN CN200880102173A patent/CN101827608A/zh active Pending
- 2008-06-13 EP EP08771083A patent/EP2167126A4/en not_active Withdrawn
- 2008-06-13 CA CA002691855A patent/CA2691855A1/en not_active Abandoned
- 2008-06-13 EA EA201000018A patent/EA201000018A1/ru unknown
- 2008-06-13 KR KR1020107000761A patent/KR20100038100A/ko not_active Application Discontinuation
- 2008-06-13 AU AU2008265930A patent/AU2008265930A1/en not_active Abandoned
- 2008-06-13 WO PCT/US2008/066990 patent/WO2008157409A1/en active Application Filing
- 2008-06-13 JP JP2010512402A patent/JP2010530003A/ja active Pending
- 2008-06-13 MX MX2009013558A patent/MX2009013558A/es not_active Application Discontinuation
-
2009
- 2009-12-10 IL IL202660A patent/IL202660A0/en unknown
- 2009-12-28 CO CO09147977A patent/CO6251275A2/es not_active Application Discontinuation
- 2009-12-30 EC EC2009009837A patent/ECSP099837A/es unknown
-
2010
- 2010-01-12 MA MA32510A patent/MA31519B1/fr unknown
Also Published As
Publication number | Publication date |
---|---|
MA31519B1 (fr) | 2010-07-01 |
EP2167126A1 (en) | 2010-03-31 |
KR20100038100A (ko) | 2010-04-12 |
JP2010530003A (ja) | 2010-09-02 |
CO6251275A2 (es) | 2011-02-21 |
WO2008157409A8 (en) | 2010-03-11 |
US20090208492A1 (en) | 2009-08-20 |
WO2008157409A1 (en) | 2008-12-24 |
IL202660A0 (en) | 2011-08-01 |
BRPI0812561A2 (pt) | 2014-10-29 |
EA201000018A1 (ru) | 2010-06-30 |
AU2008265930A1 (en) | 2008-12-24 |
CN101827608A (zh) | 2010-09-08 |
CA2691855A1 (en) | 2008-12-24 |
EP2167126A4 (en) | 2012-03-07 |
MX2009013558A (es) | 2010-03-08 |
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