SK282483B6 - Stabilná kompozícia koagulačného faktora VIII, spôsob jej prípravy a stabilizácie - Google Patents
Stabilná kompozícia koagulačného faktora VIII, spôsob jej prípravy a stabilizácie Download PDFInfo
- Publication number
- SK282483B6 SK282483B6 SK659-94A SK65994A SK282483B6 SK 282483 B6 SK282483 B6 SK 282483B6 SK 65994 A SK65994 A SK 65994A SK 282483 B6 SK282483 B6 SK 282483B6
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- Slovakia
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- composition according
- factor viii
- histidine
- mmol
- polysorbate
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- 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
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/745—Blood coagulation or fibrinolysis factors
- C07K14/755—Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
- C12N9/96—Stabilising an enzyme by forming an adduct or a composition; Forming enzyme conjugates
-
- 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
- A61K9/10—Dispersions; Emulsions
- A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
- A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S530/00—Chemistry: natural resins or derivatives; peptides or proteins; lignins or reaction products thereof
- Y10S530/827—Proteins from mammals or birds
- Y10S530/829—Blood
- Y10S530/83—Plasma; serum
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Zoology (AREA)
- Molecular Biology (AREA)
- Genetics & Genomics (AREA)
- Biochemistry (AREA)
- Hematology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Inorganic Chemistry (AREA)
- Gastroenterology & Hepatology (AREA)
- Wood Science & Technology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biomedical Technology (AREA)
- Biophysics (AREA)
- Immunology (AREA)
- General Engineering & Computer Science (AREA)
- Toxicology (AREA)
- Biotechnology (AREA)
- Microbiology (AREA)
- Dermatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Diabetes (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| SE9202878A SE9202878D0 (sv) | 1992-10-02 | 1992-10-02 | Protein formulation |
| SE9301580A SE9301580D0 (sv) | 1993-05-07 | 1993-05-07 | Protein formulation |
| SE9302006A SE9302006D0 (sv) | 1992-10-02 | 1993-06-11 | Protein formulation |
| PCT/SE1993/000793 WO1994007510A1 (en) | 1992-10-02 | 1993-10-01 | Composition comprising coagulation factor viii formulation, process for its preparation and use of a surfactant as stabilizer |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| SK65994A3 SK65994A3 (en) | 1995-03-08 |
| SK282483B6 true SK282483B6 (sk) | 2002-02-05 |
Family
ID=27355693
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SK659-94A SK282483B6 (sk) | 1992-10-02 | 1993-10-01 | Stabilná kompozícia koagulačného faktora VIII, spôsob jej prípravy a stabilizácie |
Country Status (19)
| Country | Link |
|---|---|
| US (2) | US5733873A (cs) |
| EP (3) | EP1016673B1 (cs) |
| JP (1) | JP3905921B2 (cs) |
| KR (1) | KR100303872B1 (cs) |
| AT (2) | ATE198277T1 (cs) |
| CA (1) | CA2124690C (cs) |
| CZ (1) | CZ290342B6 (cs) |
| DE (2) | DE69333974T2 (cs) |
| DK (1) | DK0627924T3 (cs) |
| ES (1) | ES2154650T3 (cs) |
| FI (1) | FI111443B (cs) |
| GR (1) | GR3035472T3 (cs) |
| HU (2) | HU220194B (cs) |
| MX (1) | MX9306133A (cs) |
| NO (1) | NO942033L (cs) |
| NZ (1) | NZ256921A (cs) |
| PT (1) | PT627924E (cs) |
| SK (1) | SK282483B6 (cs) |
| WO (1) | WO1994007510A1 (cs) |
Families Citing this family (101)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CZ290342B6 (cs) * | 1992-10-02 | 2002-07-17 | Genetics Institute Inc. | Kompozice stabilní při skladování, obsahující koagulační faktor VIII a neiontovou povrchově aktivní látku a způsob její výroby |
| SE504074C2 (sv) † | 1993-07-05 | 1996-11-04 | Pharmacia Ab | Proteinberedning för subkutan, intramuskulär eller intradermal administrering |
| US6288030B1 (en) * | 1993-12-22 | 2001-09-11 | Amgen Inc. | Stem cell factor formulations and methods |
| US6242417B1 (en) * | 1994-03-08 | 2001-06-05 | Somatogen, Inc. | Stabilized compositions containing hemoglobin |
| IL113010A0 (en) * | 1994-03-31 | 1995-10-31 | Pharmacia Ab | Pharmaceutical formulation comprising factor VIII or factor ix with an activity of at least 200 IU/ml and an enhancer for improved subcutaneous intramuscular or intradermal administration |
| US5514781A (en) * | 1994-04-11 | 1996-05-07 | Bayer Corporation | Use of azoles as virucidal agents in solutions of biologically active proteins |
| US6372716B1 (en) * | 1994-04-26 | 2002-04-16 | Genetics Institute, Inc. | Formulations for factor IX |
| SE503424C2 (sv) * | 1994-11-14 | 1996-06-10 | Pharmacia Ab | Process för rening av rekombinant koagulationsfaktor VIII |
| SE9403915D0 (sv) * | 1994-11-14 | 1994-11-14 | Annelie Almstedt | Process A |
| US7253262B2 (en) | 1995-01-19 | 2007-08-07 | Quandrant Drug Delivery Limited | Dried blood factor composition comprising trehalose |
| GB9501040D0 (en) * | 1995-01-19 | 1995-03-08 | Quadrant Holdings Cambridge | Dried composition |
| US7244824B2 (en) | 1995-01-19 | 2007-07-17 | Quadrant Drug Delivery Limited | Dried blood factor composition comprising trehalose |
| SE9501189D0 (sv) * | 1995-03-31 | 1995-03-31 | Pharmacia Ab | Protein formulation |
| US6267958B1 (en) | 1995-07-27 | 2001-07-31 | Genentech, Inc. | Protein formulation |
| AUPN801296A0 (en) * | 1996-02-12 | 1996-03-07 | Csl Limited | Stabilised growth hormone formulation and method of preparation thereof |
| US7560107B2 (en) * | 1996-06-26 | 2009-07-14 | Emory University | Modified factor VIII |
| US5763401A (en) * | 1996-07-12 | 1998-06-09 | Bayer Corporation | Stabilized albumin-free recombinant factor VIII preparation having a low sugar content |
| EP0852951A1 (de) * | 1996-11-19 | 1998-07-15 | Roche Diagnostics GmbH | Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern |
| US6475725B1 (en) | 1997-06-20 | 2002-11-05 | Baxter Aktiengesellschaft | Recombinant cell clones having increased stability and methods of making and using the same |
| PL198123B1 (pl) * | 1999-02-22 | 2008-05-30 | Baxter Int | Kompozycja czynnika VIII bez dodatku albuminy i jej zastosowanie |
| US20060099685A1 (en) * | 1999-04-15 | 2006-05-11 | Yallop Christopher A | Recombinant expression of factor VIII in human cells |
| EP1194161B1 (en) | 1999-07-13 | 2005-11-23 | Biovitrum Ab | Stable factor viii compositions |
| US6413537B1 (en) | 2000-03-10 | 2002-07-02 | Wisconsin Alumni Research Foundation | Nystatin formulation having reduced toxicity |
| GB0207092D0 (en) | 2002-03-26 | 2002-05-08 | Sod Conseils Rech Applic | Stable pharmaceutical composition containing factor VIII |
| AU2003293543A1 (en) * | 2002-12-13 | 2004-07-09 | Abgenix, Inc. | System and method for stabilizing antibodies with histidine |
| JP2007505147A (ja) | 2003-09-12 | 2007-03-08 | アンティジェニクス インコーポレーテッド | 単純ヘルペスウイルス感染の治療および予防用ワクチン |
| WO2005107776A1 (en) | 2004-05-03 | 2005-11-17 | Emory University | METHOD OF ADMINISTERING PORCINE B-DOMAINLESS fVIII |
| KR100624013B1 (ko) * | 2004-06-25 | 2006-09-19 | 주식회사 녹십자홀딩스 | 동결건조된 알부민 비함유 재조합 사람 혈액응고 제 8인자 제제 |
| GB2416122A (en) * | 2004-07-12 | 2006-01-18 | Ipsen Ltd | Botulinum neurotoxin composition |
| CN101124331B (zh) | 2004-11-12 | 2013-04-24 | 拜尔健康护理有限责任公司 | Fvⅲ的位点定向修饰 |
| PT1835938E (pt) | 2004-12-27 | 2013-11-06 | Baxter Int | Conjugados de polímero-factor de von willebrand |
| BRPI0608170A2 (pt) | 2005-04-28 | 2010-11-09 | Novo Nordisk Healthcare Ag | recipiente fechado contendo uma composição de um polipeptìdeo do fator vii ativado, processo para a preparação de um recipiente fechado contendo um polipeptìdeo do fator vii ativado, kit, e, método para a preparação de uma composição farmacêutica |
| MY151003A (en) | 2005-09-12 | 2014-03-31 | Actelion Pharmaceuticals Ltd | Stable pharmaceutical composition comprising a pyrimidine-sulfamide |
| US7855279B2 (en) | 2005-09-27 | 2010-12-21 | Amunix Operating, Inc. | Unstructured recombinant polymers and uses thereof |
| BRPI0708832A2 (pt) | 2006-03-31 | 2011-06-14 | Baxter Int | construÇço proteinÁcea |
| US7982010B2 (en) * | 2006-03-31 | 2011-07-19 | Baxter International Inc. | Factor VIII polymer conjugates |
| US7645860B2 (en) * | 2006-03-31 | 2010-01-12 | Baxter Healthcare S.A. | Factor VIII polymer conjugates |
| US7985839B2 (en) * | 2006-03-31 | 2011-07-26 | Baxter International Inc. | Factor VIII polymer conjugates |
| EP2364691B1 (en) | 2006-06-16 | 2013-04-24 | Regeneron Pharmaceuticals, Inc. | VEGF antagonist formulations suitable for intravitreal administration |
| EP2532369B1 (en) | 2006-12-15 | 2017-11-01 | Baxalta GmbH | Factor VIIa-(poly)sialic acid conjugate having prolonged in vivo half-life |
| MX2009011367A (es) | 2007-04-26 | 2010-03-22 | Bayer Healthcare Llc | Estabilizacion de soluciones liquidas de proteina recombinante para el almacenamiento congelado. |
| PT2574677T (pt) | 2007-12-27 | 2017-10-19 | Baxalta Inc | Processos para cultura de células |
| EP2113564A1 (en) * | 2008-05-01 | 2009-11-04 | Arecor Limited | Protein formulation |
| WO2010020690A1 (en) | 2008-08-21 | 2010-02-25 | Octapharma Ag | Recombinantly produced human factor viii and ix |
| CN102143759A (zh) * | 2008-09-03 | 2011-08-03 | 奥克塔法马股份有限公司 | 重组制备的因子ⅷ的新型保护组合物 |
| WO2010045321A2 (en) * | 2008-10-15 | 2010-04-22 | Baxter International Inc. | Pegylation of recombinant blood coagulation factors in the presence of bound antibodies |
| NZ593190A (en) | 2008-11-07 | 2013-01-25 | Baxter Int | Factor viii formulations |
| ES2669020T3 (es) | 2008-12-31 | 2018-05-23 | Revance Therapeutics, Inc. | Formulaciones inyectables de toxina botulínica |
| MX362028B (es) | 2009-02-03 | 2019-01-04 | Amunix Pharmaceuticals Inc | Polipeptidos recombinantes extendidos y composiciones que comprenden los mismos. |
| US10172950B2 (en) | 2009-06-09 | 2019-01-08 | Prolong Pharmaceuticals, LLC | Hemoglobin compositions |
| DK3266463T3 (da) | 2009-06-09 | 2024-01-08 | Prolong Pharmaceuticals Llc | Hæmoglobinsammensætninger |
| US10172949B2 (en) | 2009-06-09 | 2019-01-08 | Prolong Pharmaceuticals, LLC | Hemoglobin compositions |
| MX344583B (es) | 2009-06-25 | 2016-12-20 | Revance Therapeutics Inc | Formulaciones de toxina botulinica libres de albumina. |
| JP5908401B2 (ja) | 2009-07-27 | 2016-04-26 | バクスター・インターナショナル・インコーポレイテッドＢａｘｔｅｒ Ｉｎｔｅｒｎａｔｉｏｎａｌ Ｉｎｃｏｒｐ０Ｒａｔｅｄ | 血液凝固タンパク質複合体 |
| ES2856055T3 (es) | 2009-07-27 | 2021-09-27 | Baxalta GmbH | Glicopolisialilación de proteínas diferentes de las proteínas de coagulación de la sangre |
| US8642737B2 (en) | 2010-07-26 | 2014-02-04 | Baxter International Inc. | Nucleophilic catalysts for oxime linkage |
| US8809501B2 (en) | 2009-07-27 | 2014-08-19 | Baxter International Inc. | Nucleophilic catalysts for oxime linkage |
| JP5909755B2 (ja) | 2009-07-27 | 2016-04-27 | リポクセン テクノロジーズ リミテッド | 非血液凝固タンパク質の糖ポリシアル酸化 |
| BR112012004094A2 (pt) | 2009-08-24 | 2016-03-08 | Amunix Operating Inc | composições de fator vii de coagulação e métodos para fazer e usar as mesmas |
| GB0915480D0 (en) * | 2009-09-04 | 2009-10-07 | Arecor Ltd | Stable formulation of factor viii |
| US8765432B2 (en) | 2009-12-18 | 2014-07-01 | Oligasis, Llc | Targeted drug phosphorylcholine polymer conjugates |
| TR201908836T4 (tr) | 2010-07-30 | 2019-07-22 | Baxalta GmbH | Oksim bağına yönelik nükleofilik katalizörler. |
| EP2635297B1 (en) | 2010-11-05 | 2019-02-27 | Baxalta GmbH | A new variant of antihemophilic factor viii having increased specific activity |
| AU2011343813B2 (en) | 2010-12-15 | 2015-05-21 | Takeda Pharmaceutical Company Limited | Eluate collection using conductivity gradient |
| KR20130125789A (ko) * | 2010-12-16 | 2013-11-19 | 노보 노르디스크 에이/에스 | 수성 인자ⅷ 용액 |
| EA032056B1 (ru) | 2010-12-22 | 2019-04-30 | Баксалта Инкорпорейтид | Конъюгат терапевтического белка и производного жирной кислоты, способы получения конъюгата терапевтического белка и производного жирной кислоты (варианты) |
| CN111574632A (zh) | 2012-02-15 | 2020-08-25 | 比奥贝拉蒂治疗公司 | 因子viii组合物及其制备和使用方法 |
| EP3549953A1 (en) | 2012-02-15 | 2019-10-09 | Bioverativ Therapeutics Inc. | Recombinant factor viii proteins |
| AU2013204754C1 (en) | 2012-05-16 | 2018-10-11 | Takeda Pharmaceutical Company Limited | Nucleophilic Catalysts for Oxime Linkage |
| US9212357B2 (en) | 2012-12-03 | 2015-12-15 | Omrix Biopharmaceuticals Ltd. | Thrombin solution and methods of use thereof |
| WO2014144549A1 (en) | 2013-03-15 | 2014-09-18 | Biogen Idec Ma Inc. | Factor ix polypeptide formulations |
| TWI629993B (zh) * | 2013-03-15 | 2018-07-21 | 美商生物化學醫療公司 | 因子ｖｉｉｉ多肽調配物 |
| US9700486B2 (en) | 2013-04-24 | 2017-07-11 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
| EP3033097B1 (en) | 2013-08-14 | 2021-03-10 | Bioverativ Therapeutics Inc. | Factor viii-xten fusions and uses thereof |
| ES2819217T3 (es) | 2013-09-08 | 2021-04-15 | Kodiak Sciences Inc | Conjugados de polímeros iónicos dipolares y factor VIII |
| NZ722391A (en) | 2014-02-04 | 2022-12-23 | Biogen Ma Inc | Use of cation-exchange chromatography in the flow-through mode to enrich post-translational modifications |
| EP3123090A4 (en) * | 2014-03-24 | 2017-12-13 | Bioverativ Therapeutics Inc. | Lyophilized factor ix formulations |
| US12180264B2 (en) | 2014-03-24 | 2024-12-31 | R-Pharm Overseas, Inc. | IL1-R1 derived inhibitor of IL-1β and use thereof |
| CN106413741A (zh) | 2014-04-01 | 2017-02-15 | 爱德技术生物科学有限公司 | 含低糖‑甘氨酸的稳定因子viii制剂 |
| KR20160146763A (ko) * | 2014-04-01 | 2016-12-21 | 어드밴텍 바이오사이언스 파마큐티카 엘티디에이 | 부형제로서 칼슘이 첨가되지 않은 factor viii의 안정화 |
| DK3193911T5 (da) * | 2014-07-25 | 2024-10-14 | Csl Behring Gmbh | Forbedrede faktor VII-præparater til brug ved behandling af hæmofili A |
| US10238718B2 (en) * | 2014-08-04 | 2019-03-26 | Csl Limited | Factor VIII formulation |
| MA40864A (fr) | 2014-10-31 | 2017-09-05 | Biogen Ma Inc | Hypotaurine, gaba, bêta-alanine et choline pour la régulation de l'accumulation de sous-produits résiduaires dans des procédés de culture de cellules mammifères |
| CN107847572A (zh) | 2015-05-13 | 2018-03-27 | 艾吉纳斯公司 | 用于癌症治疗和预防的疫苗 |
| AR104847A1 (es) | 2015-06-17 | 2017-08-16 | Lilly Co Eli | Formulación de anticuerpo anti-cgrp |
| BR112018002150A2 (pt) | 2015-08-03 | 2018-09-18 | Bioverativ Therapeutics Inc | proteínas de fusão do fator ix e métodos de fabricação e uso das mesmas |
| WO2017076967A1 (en) * | 2015-11-05 | 2017-05-11 | Novo Nordisk A/S | Fviii formulation |
| EP3167877A1 (en) | 2015-11-12 | 2017-05-17 | Bayer Pharma Aktiengesellschaft | Method for the production of freeze-dried pellets comprising factor viii |
| SG11201804666QA (en) | 2015-12-03 | 2018-06-28 | Baxalta Inc | Factor viii with extended half-life and reduced ligand-binding properties |
| AU2017366709A1 (en) | 2016-12-02 | 2019-07-18 | Bioverativ Therapeutics Inc. | Methods of treating hemophilic arthropathy using chimeric clotting factors |
| EP3694322B1 (en) | 2017-10-09 | 2024-07-03 | Terumo BCT Biotechnologies, LLC | Lyophilization container and method of using same |
| EP3784688A2 (en) | 2018-04-26 | 2021-03-03 | Agenus Inc. | Heat shock protein-binding peptide compositions and methods of use thereof |
| SG11202010767SA (en) | 2018-05-18 | 2020-11-27 | Bioverativ Therapeutics Inc | Methods of treating hemophilia a |
| US11609042B2 (en) | 2019-03-14 | 2023-03-21 | Terumo Bct Biotechnologies, Llc | Multi-part lyophilization container and method of use |
| KR20220029733A (ko) | 2019-07-04 | 2022-03-08 | 체에스엘 베링 렝나우 아게 | 응고 인자 viii의 시험관내 안정성을 증가시키기 위한 절단된 폰 빌레브란트 인자 (vwf) |
| US11912784B2 (en) | 2019-10-10 | 2024-02-27 | Kodiak Sciences Inc. | Methods of treating an eye disorder |
| CN115768787A (zh) * | 2020-05-22 | 2023-03-07 | 阿法姆海外股份有限公司 | IL1-R1衍生的IL-1β抑制剂及其用途 |
| US20220380439A1 (en) | 2020-11-09 | 2022-12-01 | Takeda Pharmaceutical Company Limited | Purification of fviii from plasma using silicon oxide adsorption |
| BR112023026782A2 (pt) * | 2021-06-23 | 2024-03-12 | Bioverativ Therapeutics Inc | Formulações de proteínas quiméricas de fator viii e usos das mesmas |
| MX2024004494A (es) * | 2021-10-15 | 2024-07-15 | Bioverativ Therapeutics Inc | Formulaciones de proteinas quimericas de factor viii y usos de las mismas. |
| CN115554418B (zh) * | 2022-11-22 | 2023-04-14 | 四川至善唯新生物科技有限公司 | 一种重组腺相关病毒载体的药物组合物及其用途 |
Family Cites Families (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4165370A (en) * | 1976-05-21 | 1979-08-21 | Coval M L | Injectable gamma globulin |
| US4783441A (en) * | 1979-04-30 | 1988-11-08 | Hoechst Aktiengesellschaft | Aqueous protein solutions stable to denaturation |
| DE3176491D1 (en) * | 1980-03-05 | 1987-11-26 | Miles Lab | Pasteurized therapeutically active protein compositions |
| US4481189A (en) * | 1982-04-14 | 1984-11-06 | New York Blood Center Inc. | Process for preparing sterilized plasma and plasma derivatives |
| US4597966A (en) * | 1985-01-09 | 1986-07-01 | Ortho Diagnostic Systems, Inc. | Histidine stabilized immunoglobulin and method of preparation |
| SE8501050D0 (sv) * | 1985-03-05 | 1985-03-05 | Kabivitrum Ab | Biologically active fragments of human antihemophilic factor and method for preparation thereof |
| US4758657A (en) * | 1985-07-11 | 1988-07-19 | Armour Pharmaceutical Company | Method of purifying Factor VIII:C |
| CA1292686C (en) * | 1986-10-27 | 1991-12-03 | Ze'ev Shaked | Pharmaceutical compositions of recombinant interleukin-2 and formulation process |
| US4877608A (en) * | 1987-11-09 | 1989-10-31 | Rorer Pharmaceutical Corporation | Pharmaceutical plasma protein formulations in low ionic strength media |
| FR2630115B1 (fr) * | 1988-04-14 | 1994-10-28 | Merieux Inst | Procede de stabilisation des solutions d'albumine humaine et solution obtenue |
| US5096885A (en) * | 1988-04-15 | 1992-03-17 | Genentech, Inc. | Human growth hormone formulation |
| US4996047A (en) * | 1988-11-02 | 1991-02-26 | Richardson-Vicks, Inc. | Sustained release drug-resin complexes |
| DE69010518T2 (de) * | 1989-01-30 | 1994-11-03 | Corint Ltd | Wässerige Desmopressin-CMC enthaltende Arzneizubereitung. |
| SE465222C5 (sv) * | 1989-12-15 | 1998-02-10 | Pharmacia & Upjohn Ab | Ett rekombinant, humant faktor VIII-derivat och förfarande för dess framställning |
| 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 |
| CZ290342B6 (cs) * | 1992-10-02 | 2002-07-17 | Genetics Institute Inc. | Kompozice stabilní při skladování, obsahující koagulační faktor VIII a neiontovou povrchově aktivní látku a způsob její výroby |
-
1993
- 1993-10-01 CZ CZ19941328A patent/CZ290342B6/cs not_active IP Right Cessation
- 1993-10-01 ES ES93923080T patent/ES2154650T3/es not_active Expired - Lifetime
- 1993-10-01 EP EP99121997A patent/EP1016673B1/en not_active Expired - Lifetime
- 1993-10-01 AT AT93923080T patent/ATE198277T1/de active
- 1993-10-01 DE DE69333974T patent/DE69333974T2/de not_active Expired - Lifetime
- 1993-10-01 EP EP06001883A patent/EP1652534A3/en not_active Withdrawn
- 1993-10-01 PT PT93923080T patent/PT627924E/pt unknown
- 1993-10-01 KR KR1019940701858A patent/KR100303872B1/ko not_active Expired - Lifetime
- 1993-10-01 JP JP50895794A patent/JP3905921B2/ja not_active Expired - Lifetime
- 1993-10-01 AT AT99121997T patent/ATE316981T1/de active
- 1993-10-01 NZ NZ256921A patent/NZ256921A/en not_active IP Right Cessation
- 1993-10-01 MX MX9306133A patent/MX9306133A/es active IP Right Grant
- 1993-10-01 DE DE69329795T patent/DE69329795T2/de not_active Expired - Lifetime
- 1993-10-01 DK DK93923080T patent/DK0627924T3/da active
- 1993-10-01 US US08/244,266 patent/US5733873A/en not_active Expired - Lifetime
- 1993-10-01 CA CA002124690A patent/CA2124690C/en not_active Expired - Lifetime
- 1993-10-01 HU HU9401382A patent/HU220194B/hu unknown
- 1993-10-01 EP EP93923080A patent/EP0627924B1/en not_active Expired - Lifetime
- 1993-10-01 WO PCT/SE1993/000793 patent/WO1994007510A1/en not_active Ceased
- 1993-10-01 SK SK659-94A patent/SK282483B6/sk not_active IP Right Cessation
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1994
- 1994-06-01 FI FI942573A patent/FI111443B/fi not_active IP Right Cessation
- 1994-06-01 NO NO942033A patent/NO942033L/no not_active Application Discontinuation
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1995
- 1995-06-28 HU HU95P/P00473P patent/HU211670A9/hu unknown
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1997
- 1997-05-27 US US08/863,198 patent/US5919766A/en not_active Expired - Lifetime
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2001
- 2001-02-23 GR GR20010400311T patent/GR3035472T3/el unknown
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MK4A | Patent expired |
Expiry date: 20131001 |