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)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Wood Science & Technology (AREA)
- Dermatology (AREA)
- Zoology (AREA)
- Immunology (AREA)
- Gastroenterology & Hepatology (AREA)
- Molecular Biology (AREA)
- General Engineering & Computer Science (AREA)
- Genetics & Genomics (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Hematology (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 (enExample) |
| EP (1) | EP0876155B1 (enExample) |
| JP (4) | JP2000504327A (enExample) |
| AT (1) | ATE270557T1 (enExample) |
| AU (1) | AU726498B2 (enExample) |
| CA (1) | CA2241319A1 (enExample) |
| DE (1) | DE69729786T2 (enExample) |
| WO (1) | WO1997026909A1 (enExample) |
Families Citing this family (70)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5770700A (en) * | 1996-01-25 | 1998-06-23 | Genetics Institute, Inc. | Liquid factor IX formulations |
| US6171586B1 (en) * | 1997-06-13 | 2001-01-09 | Genentech, Inc. | Antibody formulation |
| US6991790B1 (en) * | 1997-06-13 | 2006-01-31 | Genentech, Inc. | Antibody formulation |
| 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 |
| US6761888B1 (en) | 2000-05-26 | 2004-07-13 | Neuralab Limited | Passive immunization treatment of Alzheimer's 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 |
| US6787523B1 (en) * | 1997-12-02 | 2004-09-07 | Neuralab Limited | Prevention and treatment of amyloidogenic disease |
| US7790856B2 (en) | 1998-04-07 | 2010-09-07 | Janssen Alzheimer Immunotherapy | Humanized antibodies that recognize beta amyloid peptide |
| US7964192B1 (en) * | 1997-12-02 | 2011-06-21 | Janssen Alzheimer Immunotherapy | Prevention and treatment of amyloidgenic disease |
| EP2039368A3 (en) | 1999-04-30 | 2009-04-01 | La Jolla Institute For Allergy And Immunology | Methods for preventing reactivation of latent virus and controlling virus replication |
| US7112576B1 (en) | 1999-12-10 | 2006-09-26 | Regents Of The University Of Minnesota | Compositions and methods for cryopreservation of peripheral blood lymphocytes |
| PT1324776E (pt) | 2000-10-12 | 2009-12-23 | Genentech Inc | Formulações de proteína concentradas de viscosidade reduzida |
| 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 |
| PE20020574A1 (es) * | 2000-12-06 | 2002-07-02 | Wyeth Corp | Anticuerpos humanizados que reconocen el peptido amiloideo beta |
| US7700751B2 (en) | 2000-12-06 | 2010-04-20 | Janssen Alzheimer Immunotherapy | Humanized antibodies that recognize β-amyloid peptide |
| US20020141970A1 (en) * | 2001-03-05 | 2002-10-03 | Pettit Dean K. | Stable aqueous solutions of granulocyte macrophage colony-stimulating factor |
| ES2325653T3 (es) | 2001-12-21 | 2009-09-11 | Novo Nordisk Health Care Ag | Composicion liquida de polipeptidos del factor vii. |
| JP2005530682A (ja) * | 2001-12-21 | 2005-10-13 | ノボ ノルディスク アクティーゼルスカブ | 修飾第ｖｉｉ因子ポリペプチドの液体組成物 |
| KR20040065278A (ko) * | 2001-12-21 | 2004-07-21 | 노보 노르디스크 에이/에스 | 변경된 인자 ⅶ 폴리펩티드의 액체 조성물 |
| DE10204792A1 (de) * | 2002-02-06 | 2003-08-14 | Merck Patent Gmbh | Lyophilisierte Zubereitung enthaltend Immuncytokine |
| MY139983A (en) * | 2002-03-12 | 2009-11-30 | Janssen Alzheimer Immunotherap | Humanized antibodies that recognize beta amyloid peptide |
| US20040009918A1 (en) * | 2002-05-03 | 2004-01-15 | Hanne Nedergaard | Stabilised solid compositions of modified factor VII |
| CA2490342C (en) | 2002-06-21 | 2015-06-16 | Novo Nordisk A/S | Stabilised solid compositions of factor vii polypeptides |
| US20040033228A1 (en) | 2002-08-16 | 2004-02-19 | Hans-Juergen Krause | Formulation of human antibodies for treating TNF-alpha associated disorders |
| NZ567324A (en) * | 2003-02-01 | 2009-08-28 | Wyeth Corp | Active immunization to generate antibodies to soluble A-beta |
| CA2518327A1 (en) * | 2003-03-18 | 2004-09-30 | Novo Nordisk Health Care Ag | Liquid, aqueous, pharmaceutical compositions of factor vii polypeptides |
| US7897734B2 (en) * | 2003-03-26 | 2011-03-01 | Novo Nordisk Healthcare Ag | Method for the production of proteins |
| HRP20050934B1 (hr) * | 2003-04-04 | 2014-09-26 | Genentech, Inc. | Formulacije s visokom koncentracijom antitijela i proteina |
| BRPI0409936A (pt) | 2003-05-23 | 2006-04-25 | Novo Nordisk Healthcare Ag | uso de um material, recipiente pelo menos parcialmente cheio, e, kit médico |
| TWI306458B (en) * | 2003-05-30 | 2009-02-21 | Elan Pharma Int Ltd | Humanized antibodies that recognize beta amyloid peptide |
| ATE547114T1 (de) * | 2003-06-25 | 2012-03-15 | Novo Nordisk Healthcare Ag | Flüssige zusammensetzungen von factor vii polypeptiden |
| DE602004023848D1 (de) * | 2003-07-01 | 2009-12-10 | Novo Nordisk Healthcare Ag | Von factor vii polypeptiden |
| WO2005016365A2 (en) * | 2003-08-14 | 2005-02-24 | Novo Nordisk Health Care Ag | Liquid, aqueous pharmaceutical composition of factor vii polypeptides |
| ES2676644T3 (es) | 2003-12-19 | 2018-07-23 | Novo Nordisk Health Care Ag | Composiciones estabilizadas de polipéptidos de factor VII |
| DE602005024955D1 (de) | 2004-03-19 | 2011-01-05 | Baxter Healthcare Sa | Faktor ixa zur behandlung von blutungsstörungen |
| WO2006005058A2 (en) * | 2004-06-30 | 2006-01-12 | Nektar Therapeutics Al, Corporation | Polymer-factor ix moiety conjugates |
| US20060051347A1 (en) | 2004-09-09 | 2006-03-09 | Winter Charles M | Process for concentration of antibodies and therapeutic products thereof |
| JP2008523815A (ja) | 2004-12-15 | 2008-07-10 | エラン ファーマ インターナショナル リミテッド | 認知の改善における使用のためのヒト化アミロイドβ抗体 |
| US7625560B2 (en) * | 2004-12-15 | 2009-12-01 | Janssen Alzheimer Immunotherapy | Humanized antibodies that recognize beta amyloid peptide |
| 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 | |
| KR20070107079A (ko) * | 2005-01-28 | 2007-11-06 | 와이어쓰 | 안정화된 액체 폴리펩타이드 제형 |
| WO2007005482A1 (en) * | 2005-06-30 | 2007-01-11 | Ge Healthcare Bio-Sciences Corp. | Detection method for gene expression |
| US8784810B2 (en) | 2006-04-18 | 2014-07-22 | Janssen Alzheimer Immunotherapy | Treatment of amyloidogenic diseases |
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| 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 |
| AU2008245821B2 (en) | 2007-04-26 | 2013-07-04 | Bayer Healthcare Llc | Stabilization of liquid solutions of recombinant protein for frozen storage |
| US7879805B2 (en) * | 2007-06-01 | 2011-02-01 | Acologix, Inc. | High temperature stable peptide formulation |
| US7678764B2 (en) | 2007-06-29 | 2010-03-16 | Johnson & Johnson Regenerative Therapeutics, Llc | Protein formulations for use at elevated temperatures |
| ES2498040T3 (es) | 2007-07-27 | 2014-09-24 | Janssen Alzheimer Immunotherapy | Tratamiento de enfermedades amiloidogénicas con anticuerpos anti-beta humanizados |
| US8058237B2 (en) | 2007-08-07 | 2011-11-15 | Advanced Technologies & Regenerative Medicine, LLC | Stable composition of GDF-5 and method of storage |
| JO3076B1 (ar) | 2007-10-17 | 2017-03-15 | Janssen Alzheimer Immunotherap | نظم العلاج المناعي المعتمد على حالة apoe |
| WO2009129101A1 (en) * | 2008-04-14 | 2009-10-22 | Advanced Technologies And Regenerative Medicine, Llc | Liquid buffered gdf-5 formulations |
| US9067981B1 (en) | 2008-10-30 | 2015-06-30 | Janssen Sciences Ireland Uc | Hybrid amyloid-beta antibodies |
| AU2010221156A1 (en) | 2009-03-06 | 2011-09-22 | Genentech, Inc. | Antibody formulation |
| JP2013520480A (ja) | 2010-02-24 | 2013-06-06 | アレコー リミテッド | 第ｉｘ因子の安定組成物 |
| SG183443A1 (en) | 2010-03-01 | 2012-09-27 | Bayer Healthcare Llc | Optimized monoclonal antibodies against tissue factor pathway inhibitor (tfpi) |
| 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 |
| EA037906B1 (ru) * | 2013-03-15 | 2021-06-04 | Биовератив Терапьютикс Инк. | Препараты полипептида фактора ix |
| US9075055B2 (en) * | 2013-03-15 | 2015-07-07 | Hycor Biomedical, Inc. | Device and associated methods for performing luminescence and fluorescence measurements of a sample |
| EP3123090A4 (en) * | 2014-03-24 | 2017-12-13 | Bioverativ Therapeutics Inc. | Lyophilized factor ix formulations |
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| 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 |
| JP7541993B2 (ja) | 2019-03-14 | 2024-08-29 | 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 | 凍結乾燥用ローディングトレイ組立体、凍結乾燥システム及び凍結乾燥方法 |
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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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| ES2045167T5 (es) * | 1987-10-23 | 1996-07-01 | Centre Regional De Transfusion | Preparacion de concentrado de factor ix humano de elevada pureza y de otras proteinas plasmaticas. |
| DE3828009A1 (de) * | 1988-08-18 | 1990-02-22 | Wolfgang D Zapp | Rahmen aus strangprofilen |
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| JP2722143B2 (ja) * | 1991-09-03 | 1998-03-04 | 株式会社ミドリ十字 | トリプシンインヒビター含有凍結乾燥製剤 |
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| IT1254359B (it) * | 1992-05-11 | 1995-09-14 | Serono Cesare Ist Ricerca | Composizioni farmaceutiche contenenti il-6 |
| DE4242863A1 (de) * | 1992-12-18 | 1994-06-23 | Boehringer Mannheim Gmbh | Stabile lyophilisierte pharmazeutische Zubereitungen von G-CSF |
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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 WO PCT/US1997/000747 patent/WO1997026909A1/en not_active Ceased
- 1997-01-09 EP EP97904797A patent/EP0876155B1/en not_active Expired - Lifetime
- 1997-01-09 AU AU17500/97A patent/AU726498B2/en not_active Ceased
- 1997-01-09 DE DE69729786T patent/DE69729786T2/de not_active Expired - Lifetime
- 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 CA CA002241319A patent/CA2241319A1/en not_active Abandoned
-
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
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
|---|---|
| JP2010189433A (ja) | 2010-09-02 |
| JP2000504327A (ja) | 2000-04-11 |
| AU1750097A (en) | 1997-08-20 |
| WO1997026909A1 (en) | 1997-07-31 |
| DE69729786D1 (de) | 2004-08-12 |
| JP2006257099A (ja) | 2006-09-28 |
| DE69729786T2 (de) | 2005-07-14 |
| JP2007262090A (ja) | 2007-10-11 |
| EP0876155A1 (en) | 1998-11-11 |
| CA2241319A1 (en) | 1997-07-31 |
| ATE270557T1 (de) | 2004-07-15 |
| JP4879104B2 (ja) | 2012-02-22 |
| EP0876155B1 (en) | 2004-07-07 |
| US5770700A (en) | 1998-06-23 |
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| FGA | Letters patent sealed or granted (standard patent) | ||
| HB | Alteration of name in register |
Owner name: GENETICS INSTITUTE, LLC Free format text: FORMER NAME WAS: GENETICS INSTITUTE, INC. |