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)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Gastroenterology & Hepatology (AREA)
- Molecular Biology (AREA)
- Wood Science & Technology (AREA)
- General Engineering & Computer Science (AREA)
- Dermatology (AREA)
- Genetics & Genomics (AREA)
- Immunology (AREA)
- Zoology (AREA)
- Hematology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Diabetes (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)
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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 |
| US7964192B1 (en) * | 1997-12-02 | 2011-06-21 | Janssen Alzheimer Immunotherapy | Prevention and treatment of amyloidgenic disease |
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| 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 |
| US7588766B1 (en) | 2000-05-26 | 2009-09-15 | Elan Pharma International Limited | Treatment of amyloidogenic disease |
| 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 |
| AU1344102A (en) | 2000-10-12 | 2002-04-22 | Genentech Inc | Reduced-viscosity concentrated protein formulations |
| US8703126B2 (en) | 2000-10-12 | 2014-04-22 | Genentech, Inc. | Reduced-viscosity concentrated protein formulations |
| AU2002225681A1 (en) * | 2000-11-15 | 2002-05-27 | 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 |
| 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. |
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| 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 |
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| DK2283856T3 (da) | 2002-06-21 | 2017-11-20 | Novo Nordisk Healthcare Ag | Stabiliserede, faste sammensætninger af Faktor VIIa-polypeptider |
| US20040033228A1 (en) | 2002-08-16 | 2004-02-19 | Hans-Juergen Krause | Formulation of human antibodies for treating TNF-alpha associated disorders |
| US20060188512A1 (en) * | 2003-02-01 | 2006-08-24 | Ted Yednock | Active immunization to generate antibodies to solble a-beta |
| BRPI0408439A (pt) * | 2003-03-18 | 2006-04-04 | Novo Nordisk Healthcare Ag | composição farmacêutica lìquida aquosa, método para preparar e uso da mesma, método para tratar uma sìndrome responsiva ao fator vii, e, recipiente hermético |
| US7897734B2 (en) * | 2003-03-26 | 2011-03-01 | Novo Nordisk Healthcare Ag | Method for the production of proteins |
| PT1610820E (pt) | 2003-04-04 | 2010-12-16 | Novartis Ag | Formulações de elevada concentração de anticorpos e proteínas |
| CA2525224A1 (en) | 2003-05-23 | 2004-12-02 | Michael Bech Jensen | Protein stabilization in solution |
| 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 |
| EP1656158B1 (en) * | 2003-08-14 | 2016-03-09 | Novo Nordisk Health Care AG | Liquid, aqueous pharmaceutical composition of factor vii polypeptides |
| CN1917861B (zh) * | 2003-12-19 | 2012-03-21 | 诺和诺德医疗保健公司 | 因子vii多肽的稳定化固体组合物 |
| EP1755652B1 (en) | 2004-03-19 | 2010-11-24 | Baxter International Inc. | Factor ixa for the treatment of bleeding disorders |
| EP1765411B2 (en) * | 2004-06-30 | 2017-10-11 | Nektar Therapeutics | 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 |
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| AR051800A1 (es) * | 2004-12-15 | 2007-02-07 | Wyeth Corp | Anticuerpos a beta usados en mejorar la cognicion |
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| GT200600031A (es) * | 2005-01-28 | 2006-08-29 | Formulacion anticuerpo anti a beta | |
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| JP5058160B2 (ja) * | 2005-06-30 | 2012-10-24 | ジーイー・ヘルスケア・バイオサイエンス・コーポレイション | 遺伝子発現の検出方法 |
| US8784810B2 (en) | 2006-04-18 | 2014-07-22 | Janssen Alzheimer Immunotherapy | Treatment of amyloidogenic diseases |
| WO2009017467A1 (en) | 2007-07-27 | 2009-02-05 | Elan Pharma International Limited | Treatment of amyloidogenic diseases |
| SI2364691T1 (sl) | 2006-06-16 | 2013-08-30 | Regeneron Pharmaceuticals, Inc. | Formulacije antagonista VEGF, primerne za intravitrealno dajanje |
| AU2007234612B2 (en) * | 2006-12-14 | 2013-06-27 | Johnson & Johnson Regenerative Therapeutics, Llc | Protein stabilization formulations |
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| US8003097B2 (en) | 2007-04-18 | 2011-08-23 | Janssen Alzheimer Immunotherapy | Treatment of cerebral amyloid angiopathy |
| JP5401446B2 (ja) | 2007-04-26 | 2014-01-29 | バイエル ヘルスケア エルエルシー | 凍結貯蔵を目的とした、組み換えタンパク質溶液の安定化 |
| 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 |
| CA2695697A1 (en) | 2007-08-07 | 2009-02-12 | Advanced Technologies And Regenerative Medicine, Llc | Protein formulations comprising gdf-5 in aqueous acidic solution |
| JO3076B1 (ar) | 2007-10-17 | 2017-03-15 | Janssen Alzheimer Immunotherap | نظم العلاج المناعي المعتمد على حالة apoe |
| AU2009236459B2 (en) * | 2008-04-14 | 2013-07-25 | 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 |
| WO2011104552A1 (en) | 2010-02-24 | 2011-09-01 | Arecor Limited | Stable compositions of factor ix |
| KR101807894B1 (ko) | 2010-03-01 | 2017-12-12 | 바이엘 헬스케어 엘엘씨 | 조직 인자 경로 억제제 (ｔｆｐｉ)에 대한 최적화된 모노클로날 항체 |
| US9592297B2 (en) | 2012-08-31 | 2017-03-14 | Bayer Healthcare Llc | Antibody and protein formulations |
| US8613919B1 (en) | 2012-08-31 | 2013-12-24 | Bayer Healthcare, Llc | High concentration antibody and protein formulations |
| JP6553020B2 (ja) * | 2013-03-15 | 2019-07-31 | ジーピービー デット ホールディングス トゥー エルエルシー | アレルギー及び自己免疫疾患に関する診断分析を行うための自動化された免疫分析計システム |
| AU2014228938B2 (en) * | 2013-03-15 | 2019-05-02 | Bioverativ Therapeutics Inc. | Factor IX polypeptide formulations |
| WO2015148444A1 (en) * | 2014-03-24 | 2015-10-01 | Biogen Ma Inc. | Lyophilized factor ix formulations |
| MX2018006740A (es) | 2015-12-03 | 2018-08-01 | Regeneron Pharma | Metodos para asociar variantes geneticas con un resultado clinico en pacientes que sufren de degeneracion relacionada con la edad tratados con anti-factor de crecimiento endotelial vascular (vegf). |
| WO2019074886A1 (en) | 2017-10-09 | 2019-04-18 | Terumo Bct Biotechnologies, Llc | LYOPHILIZATION CONTAINER AND METHOD OF USE |
| 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 |
| WO2020242552A1 (en) | 2019-03-14 | 2020-12-03 | Terumo Bct Biotechnologies, Llc | Multi-part lyophilization container and method of use |
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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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| JP2715104B2 (ja) * | 1988-08-18 | 1998-02-18 | 株式会社ミドリ十字 | トロンビン乾燥製剤 |
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| DE3939346A1 (de) * | 1989-11-29 | 1991-06-06 | Behringwerke Ag | Arzneimitel zur subkutanen oder intramuskulaeren applikation enthaltend polypeptide |
| DE4001451A1 (de) * | 1990-01-19 | 1991-08-01 | Octapharma Ag | Stabile injizierbare loesungen von faktor viii und faktor ix |
| DE4111393A1 (de) * | 1991-04-09 | 1992-10-15 | Behringwerke Ag | Stabilisierte faktor viii-praeparationen |
| 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 |
| JPH05331071A (ja) * | 1992-01-17 | 1993-12-14 | Asahi Chem Ind Co Ltd | カルシトニン遺伝子関連ペプチド類の凍結乾燥組成物および安定化法 |
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| IT1254359B (it) * | 1992-05-11 | 1995-09-14 | Serono Cesare Ist Ricerca | Composizioni farmaceutiche contenenti il-6 |
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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 DE DE69729786T patent/DE69729786T2/de not_active Expired - Lifetime
- 1997-01-09 AT AT97904797T patent/ATE270557T1/de not_active IP Right Cessation
- 1997-01-09 WO PCT/US1997/000747 patent/WO1997026909A1/en not_active Ceased
- 1997-01-09 JP JP9526917A patent/JP2000504327A/ja not_active Withdrawn
- 1997-01-09 CA CA002241319A patent/CA2241319A1/en not_active Abandoned
- 1997-01-09 AU AU17500/97A patent/AU726498B2/en not_active Ceased
- 1997-01-09 EP EP97904797A patent/EP0876155B1/en 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
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 |
|---|---|
| JP2000504327A (ja) | 2000-04-11 |
| WO1997026909A1 (en) | 1997-07-31 |
| DE69729786T2 (de) | 2005-07-14 |
| EP0876155A1 (en) | 1998-11-11 |
| JP2010189433A (ja) | 2010-09-02 |
| JP2007262090A (ja) | 2007-10-11 |
| AU1750097A (en) | 1997-08-20 |
| US5770700A (en) | 1998-06-23 |
| JP2006257099A (ja) | 2006-09-28 |
| CA2241319A1 (en) | 1997-07-31 |
| JP4879104B2 (ja) | 2012-02-22 |
| EP0876155B1 (en) | 2004-07-07 |
| ATE270557T1 (de) | 2004-07-15 |
| DE69729786D1 (de) | 2004-08-12 |
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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. |