AU726498B2 - Highly concentrated, lyophilized, and liquid factor IX formulations - Google Patents
Highly concentrated, lyophilized, and liquid factor IX formulations Download PDFInfo
- Publication number
- AU726498B2 AU726498B2 AU17500/97A AU1750097A AU726498B2 AU 726498 B2 AU726498 B2 AU 726498B2 AU 17500/97 A AU17500/97 A AU 17500/97A AU 1750097 A AU1750097 A AU 1750097A AU 726498 B2 AU726498 B2 AU 726498B2
- Authority
- AU
- Australia
- Prior art keywords
- factor
- concentration
- arginine
- protein
- sucrose
- 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.)
- Ceased
Links
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
- A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
- A61K38/482—Serine endopeptidases (3.4.21)
- A61K38/4846—Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K9/0012—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
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Y—ENZYMES
- C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
- C12Y304/21—Serine endopeptidases (3.4.21)
- C12Y304/21022—Coagulation factor IXa (3.4.21.22)
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Dermatology (AREA)
- General Engineering & Computer Science (AREA)
- Genetics & Genomics (AREA)
- Wood Science & Technology (AREA)
- Zoology (AREA)
- Molecular Biology (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Hematology (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/591332 | 1996-01-25 | ||
| US08/591,332 US5770700A (en) | 1996-01-25 | 1996-01-25 | Liquid factor IX formulations |
| PCT/US1997/000747 WO1997026909A1 (en) | 1996-01-25 | 1997-01-09 | Highly concentrated, lyophilized, and liquid factor ix formulations |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| AU1750097A AU1750097A (en) | 1997-08-20 |
| AU726498B2 true AU726498B2 (en) | 2000-11-09 |
Family
ID=24366077
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU17500/97A Ceased AU726498B2 (en) | 1996-01-25 | 1997-01-09 | Highly concentrated, lyophilized, and liquid factor IX formulations |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US5770700A (https=) |
| EP (1) | EP0876155B1 (https=) |
| JP (4) | JP2000504327A (https=) |
| AT (1) | ATE270557T1 (https=) |
| AU (1) | AU726498B2 (https=) |
| CA (1) | CA2241319A1 (https=) |
| DE (1) | DE69729786T2 (https=) |
| WO (1) | WO1997026909A1 (https=) |
Families Citing this family (70)
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| US5770700A (en) * | 1996-01-25 | 1998-06-23 | Genetics Institute, Inc. | Liquid factor IX formulations |
| US6991790B1 (en) | 1997-06-13 | 2006-01-31 | Genentech, Inc. | Antibody formulation |
| US6171586B1 (en) * | 1997-06-13 | 2001-01-09 | Genentech, Inc. | Antibody formulation |
| US6787523B1 (en) * | 1997-12-02 | 2004-09-07 | Neuralab Limited | Prevention and treatment of amyloidogenic disease |
| US7964192B1 (en) * | 1997-12-02 | 2011-06-21 | Janssen Alzheimer Immunotherapy | Prevention and treatment of amyloidgenic disease |
| US7588766B1 (en) | 2000-05-26 | 2009-09-15 | Elan Pharma International Limited | Treatment of amyloidogenic disease |
| US20080050367A1 (en) * | 1998-04-07 | 2008-02-28 | Guriq Basi | Humanized antibodies that recognize beta amyloid peptide |
| TWI239847B (en) * | 1997-12-02 | 2005-09-21 | Elan Pharm Inc | N-terminal fragment of Abeta peptide and an adjuvant for preventing and treating amyloidogenic disease |
| US7790856B2 (en) | 1998-04-07 | 2010-09-07 | Janssen Alzheimer Immunotherapy | Humanized antibodies that recognize beta amyloid peptide |
| US6761888B1 (en) | 2000-05-26 | 2004-07-13 | Neuralab Limited | Passive immunization treatment of Alzheimer's disease |
| JP3581660B2 (ja) | 1999-04-30 | 2004-10-27 | ラ ホヤ インスティチュート フォー アラジー アンド イムノロジー | 潜伏ウイルスの再活性化を予防しウイルスの複製を制御するための方法 |
| US7112576B1 (en) | 1999-12-10 | 2006-09-26 | Regents Of The University Of Minnesota | Compositions and methods for cryopreservation of peripheral blood lymphocytes |
| AU2002213441B2 (en) | 2000-10-12 | 2006-10-26 | Genentech, Inc. | Reduced-viscosity concentrated protein formulations |
| US8703126B2 (en) | 2000-10-12 | 2014-04-22 | Genentech, Inc. | Reduced-viscosity concentrated protein formulations |
| WO2002039951A2 (en) * | 2000-11-15 | 2002-05-23 | Globe Immune, Inc. | Yeast-dentritic cell vaccines and uses thereof |
| TWI255272B (en) * | 2000-12-06 | 2006-05-21 | Guriq Basi | Humanized antibodies that recognize beta amyloid peptide |
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| US20020141970A1 (en) * | 2001-03-05 | 2002-10-03 | Pettit Dean K. | Stable aqueous solutions of granulocyte macrophage colony-stimulating factor |
| EP1458407A1 (en) * | 2001-12-21 | 2004-09-22 | Novo Nordisk A/S | Liquid composition of modified factor vii polypeptides |
| AU2002351756A1 (en) * | 2001-12-21 | 2003-07-15 | Novo Nordisk Health Care Ag | Liquid composition of factor vii polypeptides |
| KR20040065278A (ko) * | 2001-12-21 | 2004-07-21 | 노보 노르디스크 에이/에스 | 변경된 인자 ⅶ 폴리펩티드의 액체 조성물 |
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| US20040009918A1 (en) * | 2002-05-03 | 2004-01-15 | Hanne Nedergaard | Stabilised solid compositions of modified factor VII |
| PT1517698E (pt) | 2002-06-21 | 2014-11-19 | Novo Nordisk Healthcare Ag | Composições sólidas estabilizadas de polipéptidos do fator viia |
| US20040033228A1 (en) | 2002-08-16 | 2004-02-19 | Hans-Juergen Krause | Formulation of human antibodies for treating TNF-alpha associated disorders |
| MXPA05008156A (es) * | 2003-02-01 | 2005-09-30 | Neuralab Ltd | Inmunizacion activa para generar anticuerpos para beta-a soluble. |
| RU2005132164A (ru) * | 2003-03-18 | 2006-06-10 | Ново Нордиск Хелт Кэр Аг (Ch) | Жидкие, водные фармацевтические композиции полипептидов фактора vii |
| US7897734B2 (en) * | 2003-03-26 | 2011-03-01 | Novo Nordisk Healthcare Ag | Method for the production of proteins |
| CN1798575A (zh) | 2003-04-04 | 2006-07-05 | 健泰科生物技术公司 | 高浓度抗体和蛋白制剂 |
| KR20060015574A (ko) | 2003-05-23 | 2006-02-17 | 노보 노르디스크 헬스 케어 악티엔게젤샤프트 | 용액 중 단백질 안정화 |
| PE20050627A1 (es) * | 2003-05-30 | 2005-08-10 | Wyeth Corp | Anticuerpos humanizados que reconocen el peptido beta amiloideo |
| WO2004112828A1 (en) * | 2003-06-25 | 2004-12-29 | Novo Nordisk Health Care Ag | Liquid composition of factor vii polypeptides |
| EP1644030B1 (en) * | 2003-07-01 | 2009-10-28 | Novo Nordisk Health Care AG | Liquid, aqueous pharmaceutical composition of factor vii polypeptides |
| ES2574581T3 (es) * | 2003-08-14 | 2016-06-20 | Novo Nordisk Health Care Ag | Composición farmacéutica líquida acuosa de polipéptidos de tipo Factor VII |
| RU2373953C2 (ru) | 2003-12-19 | 2009-11-27 | Ново Нордиск Хелс Кеа Аг | Стабилизированная композиция, содержащая полипептид фактора vii |
| CA2557061C (en) * | 2004-03-19 | 2013-08-20 | Baxter International Inc. | Factor ixa for the treatment of bleeding disorders |
| KR101146160B1 (ko) * | 2004-06-30 | 2012-07-16 | 넥타르 테라퓨틱스 | 중합체인자 ｉｘ 부분의 접합체 |
| US20060051347A1 (en) | 2004-09-09 | 2006-03-09 | Winter Charles M | Process for concentration of antibodies and therapeutic products thereof |
| TW200636066A (en) * | 2004-12-15 | 2006-10-16 | Elan Pharm Inc | Humanized antibodies that recognize beta amyloid peptide |
| WO2006066089A1 (en) | 2004-12-15 | 2006-06-22 | Neuralab Limited | Humanized amyloid beta antibodies for use in improving cognition |
| EP1838349A1 (en) * | 2004-12-15 | 2007-10-03 | Neuralab, Ltd. | Amyloid beta antibodies for use in improving cognition |
| GT200600031A (es) * | 2005-01-28 | 2006-08-29 | Formulacion anticuerpo anti a beta | |
| BRPI0606867A2 (pt) * | 2005-01-28 | 2009-07-21 | Wyeth Corp | formulação lìquida; forma de dosagem unitária farmacêutica; kit; recipiente; método para aumentar a estabilidade de um polipeptìdeo de ligação a antìgeno numa formulação; método para preparar uma forma de dosagem unitária farmacêutica; formulação estável; formulação; e produto terapêutico |
| DE602006018622D1 (de) * | 2005-06-30 | 2011-01-13 | Ge Healthcare Bio Sciences | Nachweisverfahren für die genexpression |
| US8784810B2 (en) | 2006-04-18 | 2014-07-22 | Janssen Alzheimer Immunotherapy | Treatment of amyloidogenic diseases |
| US7608261B2 (en) | 2006-06-16 | 2009-10-27 | Regeneron Pharmacuticals, Inc. | VEGF antagonist formulations suitable for intravitreal administration |
| AU2007234612B2 (en) | 2006-12-14 | 2013-06-27 | Johnson & Johnson Regenerative Therapeutics, Llc | Protein stabilization formulations |
| US8449520B2 (en) * | 2007-03-19 | 2013-05-28 | HemCon Medical Technologies Inc. | Apparatus and methods for making, storing, and administering freeze-dried materials such as freeze-dried plasma |
| US8003097B2 (en) | 2007-04-18 | 2011-08-23 | Janssen Alzheimer Immunotherapy | Treatment of cerebral amyloid angiopathy |
| RU2469739C2 (ru) | 2007-04-26 | 2012-12-20 | БАЙЕР ХЕЛСКЕА ЛЛСи | Стабилизация жидких растворов рекомбинантного белка для хранения в замороженном состоянии |
| JP2010530846A (ja) * | 2007-06-01 | 2010-09-16 | アコロジックス インコーポレイティッド | 高温で安定なペプチド製剤 |
| US7678764B2 (en) | 2007-06-29 | 2010-03-16 | Johnson & Johnson Regenerative Therapeutics, Llc | Protein formulations for use at elevated temperatures |
| PT2182983E (pt) | 2007-07-27 | 2014-09-01 | Janssen Alzheimer Immunotherap | Tratamento de doenças amiloidogénicas com anticorpos anti-abeta humanizados |
| CN101801405A (zh) | 2007-08-07 | 2010-08-11 | 先进科技及再生医学有限责任公司 | 包含于酸性水溶液中的gdf-5的蛋白质配方 |
| JO3076B1 (ar) | 2007-10-17 | 2017-03-15 | Janssen Alzheimer Immunotherap | نظم العلاج المناعي المعتمد على حالة apoe |
| BRPI0911048A2 (pt) * | 2008-04-14 | 2015-12-29 | Atrm Llc | formulações líquidas tamponadas de gdf-5 |
| US9067981B1 (en) | 2008-10-30 | 2015-06-30 | Janssen Sciences Ireland Uc | Hybrid amyloid-beta antibodies |
| AR076640A1 (es) | 2009-03-06 | 2011-06-29 | Genentech Inc | Formulacion con anticuerpo. metodo para estabilizar anticuerpo. articulo de manufactura |
| WO2011104552A1 (en) | 2010-02-24 | 2011-09-01 | Arecor Limited | Stable compositions of factor ix |
| HUE047173T2 (hu) | 2010-03-01 | 2020-04-28 | Bayer Healthcare Llc | Optimalizált monoklonális ellenanyagok szöveti faktor útvonal inhibitor (TFPI) ellen |
| US8613919B1 (en) | 2012-08-31 | 2013-12-24 | Bayer Healthcare, Llc | High concentration antibody and protein formulations |
| US9592297B2 (en) | 2012-08-31 | 2017-03-14 | Bayer Healthcare Llc | Antibody and protein formulations |
| EP3933384A1 (en) | 2013-03-15 | 2022-01-05 | Hycor Biomedical, LLC | Device and associated method for performing luminescence and fluorescence measurements of a sample |
| AR095527A1 (es) | 2013-03-15 | 2015-10-21 | Biogen Idec Inc | Formulaciones de polipéptido fc-factor ix |
| EA202092926A3 (ru) * | 2014-03-24 | 2021-10-29 | Биовератив Терапьютикс Инк. | Лиофилизированные составы, содержащие фактор ix |
| PT3384049T (pt) | 2015-12-03 | 2023-08-18 | Regeneron Pharma | Método de associação de variantes genéticas com um resultado clínico em doentes que sofrem de degeneração macular relacionada à idade tratados com anti-vegf |
| JP7110360B2 (ja) | 2017-10-09 | 2022-08-01 | テルモ ビーシーティー バイオテクノロジーズ，エルエルシー | 凍結乾燥方法 |
| US11519020B2 (en) | 2018-05-25 | 2022-12-06 | Regeneron Pharmaceuticals, Inc. | Methods of associating genetic variants with a clinical outcome in patients suffering from age-related macular degeneration treated with anti-VEGF |
| CN113614477B (zh) | 2019-03-14 | 2023-04-28 | 泰尔茂比司特生物技术有限公司 | 冷冻干燥装载托盘组件及系统 |
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| EP0137376A2 (en) * | 1983-10-10 | 1985-04-17 | VAMATEX S.p.A. | Means to guide weft carrying grippers along the shed of weaving looms |
| WO1995026750A1 (en) * | 1994-03-31 | 1995-10-12 | Pharmacia Ab | Pharmaceutical formulation for subcutaneous, intramuscular or intradermal administration of factor viii or factor ix |
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| DE3045153A1 (de) * | 1980-11-29 | 1982-07-08 | Behringwerke Ag, 3550 Marburg | Verfahren zur herstellung von blutgerinnungsfaktoren und danach hergestellte praeparation der faktoren ix und x |
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| JP2577744B2 (ja) * | 1986-07-18 | 1997-02-05 | 中外製薬株式会社 | 安定な顆粒球コロニ−刺激因子含有製剤 |
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| US5770700A (en) * | 1996-01-25 | 1998-06-23 | Genetics Institute, Inc. | Liquid factor IX formulations |
-
1996
- 1996-01-25 US US08/591,332 patent/US5770700A/en not_active Expired - Lifetime
-
1997
- 1997-01-09 AU AU17500/97A patent/AU726498B2/en not_active Ceased
- 1997-01-09 WO PCT/US1997/000747 patent/WO1997026909A1/en not_active Ceased
- 1997-01-09 CA CA002241319A patent/CA2241319A1/en not_active Abandoned
- 1997-01-09 JP JP9526917A patent/JP2000504327A/ja not_active Withdrawn
- 1997-01-09 AT AT97904797T patent/ATE270557T1/de not_active IP Right Cessation
- 1997-01-09 EP EP97904797A patent/EP0876155B1/en not_active Expired - Lifetime
- 1997-01-09 DE DE69729786T patent/DE69729786T2/de not_active Expired - Lifetime
-
2006
- 2006-05-22 JP JP2006141684A patent/JP2006257099A/ja active Pending
-
2007
- 2007-07-10 JP JP2007180835A patent/JP4879104B2/ja not_active Expired - Lifetime
-
2010
- 2010-05-06 JP JP2010106673A patent/JP2010189433A/ja not_active Withdrawn
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| EP0137376A2 (en) * | 1983-10-10 | 1985-04-17 | VAMATEX S.p.A. | Means to guide weft carrying grippers along the shed of weaving looms |
| WO1995026750A1 (en) * | 1994-03-31 | 1995-10-12 | Pharmacia Ab | Pharmaceutical formulation for subcutaneous, intramuscular or intradermal administration of factor viii or factor ix |
Also Published As
| Publication number | Publication date |
|---|---|
| JP2000504327A (ja) | 2000-04-11 |
| AU1750097A (en) | 1997-08-20 |
| JP2006257099A (ja) | 2006-09-28 |
| CA2241319A1 (en) | 1997-07-31 |
| JP4879104B2 (ja) | 2012-02-22 |
| DE69729786D1 (de) | 2004-08-12 |
| DE69729786T2 (de) | 2005-07-14 |
| WO1997026909A1 (en) | 1997-07-31 |
| EP0876155B1 (en) | 2004-07-07 |
| JP2007262090A (ja) | 2007-10-11 |
| JP2010189433A (ja) | 2010-09-02 |
| EP0876155A1 (en) | 1998-11-11 |
| ATE270557T1 (de) | 2004-07-15 |
| US5770700A (en) | 1998-06-23 |
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