KR920019371A - 안정화된 인자 ⅷ 제제 - Google Patents
안정화된 인자 ⅷ 제제 Download PDFInfo
- Publication number
- KR920019371A KR920019371A KR1019920005733A KR920005733A KR920019371A KR 920019371 A KR920019371 A KR 920019371A KR 1019920005733 A KR1019920005733 A KR 1019920005733A KR 920005733 A KR920005733 A KR 920005733A KR 920019371 A KR920019371 A KR 920019371A
- Authority
- KR
- South Korea
- Prior art keywords
- solution
- activity
- amino acid
- factor vii
- derivatives
- 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.)
- Granted
Links
- 102000001690 Factor VIII Human genes 0.000 title 1
- 108010054218 Factor VIII Proteins 0.000 title 1
- 229960000301 factor viii Drugs 0.000 title 1
- 238000009472 formulation Methods 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
- 230000000694 effects Effects 0.000 claims abstract 5
- 150000001413 amino acids Chemical class 0.000 claims 7
- 102100023804 Coagulation factor VII Human genes 0.000 claims 3
- 108010023321 Factor VII Proteins 0.000 claims 3
- 239000003599 detergent Substances 0.000 claims 3
- 229940012413 factor vii Drugs 0.000 claims 3
- 229920000620 organic polymer Polymers 0.000 claims 3
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims 2
- 239000003814 drug Substances 0.000 claims 2
- 150000003839 salts Chemical class 0.000 claims 2
- 239000004475 Arginine Substances 0.000 claims 1
- 239000004471 Glycine Substances 0.000 claims 1
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 claims 1
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims 1
- 239000012928 buffer substance Substances 0.000 claims 1
- 150000001720 carbohydrates Chemical class 0.000 claims 1
- 235000014633 carbohydrates Nutrition 0.000 claims 1
- 229940099816 human factor vii Drugs 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 239000008177 pharmaceutical agent Substances 0.000 claims 1
- 230000000087 stabilizing effect Effects 0.000 claims 1
- 230000015271 coagulation Effects 0.000 abstract 1
- 238000005345 coagulation Methods 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
-
- 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
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/36—Blood coagulation or fibrinolysis factors
- A61K38/37—Factors VIII
-
- 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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Hematology (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Diabetes (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Abstract
Description
Claims (12)
- 아미노산 또는 이의 염 또는 유도체중의 하나 및 필요에 따라, 청정제 및 유기 중합체를 함유하는 인자 Ⅷ : C 활성을 갖는 용액.
- 제1항에 있어서, 아미노산이 천연 아미노산인 용액.
- 제1항에 있어서, 아미노산이 염기성 아미노산인 용액.
- 제1항에 있어서, 아르기닌과 글라이신을 함유하는 용액.
- 제1항에 있어서, 아미노산의 농도가 0.001 내지 1㏖/ℓ인 용액.
- 제1항에 있어서, 유기 중합체 또는 비이온성 청정제를 함유하는 용액.
- 제1항에 있어서, F Ⅷ : C 활성이 혈장중에서 나타나는 형태의 사람인자 Ⅷ 또는 유전공학적으로 조작된 인자 Ⅷ : C 또는 이들의 유도체로부터 유도되는 용액.
- 제1항에 있어서, 특이 F Ⅷ : C 활성이 적어도 1000IU/㎎인 용액.
- 제1항에 따른 용액을 함유하는 약제.
- 제9항에 있어서, 통상적으로 약학적으로 적합한 안정화 및/또는 완충물질을 함유하는 약제.
- 제10항에 있어서, 탄수화물을 함유하는 약제.
- 아미노산 또는 이의 염 또는 유도체중의 하나 및, 필요할 경우, 유기 중합체 또는 청정제를 인자 Ⅷ : C 활성을 갖는 용액에 가함을 특징으로 하여 제1항에 따른 용액을 제조하는 방법.※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DEP4111393.4 | 1991-04-09 | ||
DE4111393A DE4111393A1 (de) | 1991-04-09 | 1991-04-09 | Stabilisierte faktor viii-praeparationen |
Publications (2)
Publication Number | Publication Date |
---|---|
KR920019371A true KR920019371A (ko) | 1992-11-19 |
KR100231398B1 KR100231398B1 (ko) | 1999-11-15 |
Family
ID=6429102
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
KR1019920005733A Expired - Lifetime KR100231398B1 (ko) | 1991-04-09 | 1992-04-07 | 응고인자 viii 활성을 지닌 안정화된 액제 |
Country Status (12)
Country | Link |
---|---|
US (1) | US5565427C1 (ko) |
EP (1) | EP0508194B1 (ko) |
JP (2) | JP3777467B2 (ko) |
KR (1) | KR100231398B1 (ko) |
AT (1) | ATE160942T1 (ko) |
AU (1) | AU651188B2 (ko) |
CA (1) | CA2065553C (ko) |
DE (2) | DE4111393A1 (ko) |
DK (1) | DK0508194T3 (ko) |
ES (1) | ES2111579T4 (ko) |
GR (1) | GR3025873T3 (ko) |
IE (1) | IE921124A1 (ko) |
Families Citing this family (43)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DK0627924T3 (da) * | 1992-10-02 | 2001-04-30 | Genetics Inst | Sammensætning, der omfatter koagulationsfaktor VIII formulering, fremgangsmåde til dens fremstilling og anvendelse af et overfladeaktivt middel som stabilisator |
SE9302006D0 (sv) * | 1992-10-02 | 1993-06-11 | Kabi Pharmacia Ab | Protein formulation |
SE9301581D0 (sv) * | 1993-05-07 | 1993-05-07 | Kabi Pharmacia Ab | Protein formulation |
SE504074C2 (sv) † | 1993-07-05 | 1996-11-04 | Pharmacia Ab | Proteinberedning för subkutan, intramuskulär eller intradermal administrering |
US6372716B1 (en) | 1994-04-26 | 2002-04-16 | Genetics Institute, Inc. | Formulations for factor IX |
US7253262B2 (en) * | 1995-01-19 | 2007-08-07 | Quandrant Drug Delivery Limited | Dried blood factor composition comprising trehalose |
US7244824B2 (en) * | 1995-01-19 | 2007-07-17 | Quadrant Drug Delivery Limited | Dried blood factor composition comprising trehalose |
GB9501040D0 (en) * | 1995-01-19 | 1995-03-08 | Quadrant Holdings Cambridge | Dried composition |
US5925738A (en) * | 1995-12-01 | 1999-07-20 | The American National Red Cross | Methods of production and use of liquid formulations of plasma proteins |
US5770700A (en) * | 1996-01-25 | 1998-06-23 | Genetics Institute, Inc. | Liquid factor IX formulations |
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 |
US6586573B1 (en) | 1999-02-22 | 2003-07-01 | Baxter International Inc. | Albumin-free Factor VIII formulations |
CN1245216C (zh) | 1999-10-04 | 2006-03-15 | 希龙公司 | 稳定化的含多肽的液体药物组合物 |
GB0207092D0 (en) | 2002-03-26 | 2002-05-08 | Sod Conseils Rech Applic | Stable pharmaceutical composition containing factor VIII |
CN1756559B (zh) | 2003-01-08 | 2010-04-28 | 诺华疫苗和诊断公司 | 稳定的含组织因子通路抑制剂或组织因子通路抑制剂变体的液体组合物 |
HUE058897T2 (hu) * | 2003-02-26 | 2022-09-28 | Nektar Therapeutics | Polimer VIII-as faktor egység konjugátumok |
DE10333317A1 (de) † | 2003-07-22 | 2005-02-17 | Biotecon Therapeutics Gmbh | Formulierung für Proteinarzneimittel ohne Zusatz von humanem Serumalbumin (HSA) |
ES2229931B1 (es) * | 2003-10-03 | 2006-01-16 | Grifols, S.A. | Composicion liquida bilogicamente estable de fviii, de fvw o del complejo fviii/fvw humanos. |
SI1750733T1 (sl) | 2004-05-03 | 2014-03-31 | Emory University | POSTOPEK DAJANJA PRAĹ IÄŚJEGA fVIII BREZ DOMENE B |
CA2591852A1 (en) | 2004-12-27 | 2006-07-06 | Baxter International Inc. | Polymer-von willebrand factor-conjugates |
EP1899462B1 (en) * | 2005-07-02 | 2011-03-09 | Arecor Limited | Stable aqueous systems comprising proteins |
US7645860B2 (en) | 2006-03-31 | 2010-01-12 | Baxter Healthcare S.A. | Factor VIII polymer conjugates |
WO2007126808A1 (en) * | 2006-03-31 | 2007-11-08 | Baxter International Inc | Pegylated factor viii |
DK2126106T3 (en) * | 2007-02-23 | 2017-12-04 | Sk Chemicals Co Ltd | Process for the preparation and purification of Factor VIII and its derivatives |
BRPI0810500A2 (pt) | 2007-04-26 | 2014-10-14 | Bayer Healthcare Llc | Estabilização de soluções líquidas de proteína recombinante para armazenagem no estado de congelamento |
CA2732423A1 (en) | 2008-08-21 | 2010-02-25 | Octapharma Ag | Recombinantly produced human factor viii and ix |
AU2009289212B2 (en) * | 2008-09-03 | 2015-02-12 | Octapharma Ag | New protecting compositions for recombinantly produced factor VIII |
JP5779780B2 (ja) | 2008-11-07 | 2015-09-16 | 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 | 第viii因子製剤 |
US10172950B2 (en) | 2009-06-09 | 2019-01-08 | Prolong Pharmaceuticals, LLC | Hemoglobin compositions |
KR20180126103A (ko) | 2009-06-09 | 2018-11-26 | 프로롱 파마슈티컬스, 엘엘씨 | 헤모글로빈 조성물 |
US10172949B2 (en) | 2009-06-09 | 2019-01-08 | Prolong Pharmaceuticals, LLC | Hemoglobin compositions |
GB0915480D0 (en) | 2009-09-04 | 2009-10-07 | Arecor Ltd | Stable formulation of factor viii |
EA032336B1 (ru) * | 2010-09-17 | 2019-05-31 | Баксалта Инкорпорейтид | Стабильная водная иммуноглобулиновая композиция и способ стабилизации иммуноглобулиновой композиции |
KR101948337B1 (ko) | 2010-11-05 | 2019-02-14 | 박스알타 인코퍼레이티드 | 증가된 특이 활성도를 갖는 항혈우병 인자 viii의 신규 변이체 |
CN103703141B (zh) | 2011-04-08 | 2016-08-17 | 伯乐实验室公司 | 具有降低的非特异性活性的pcr反应混合物 |
JP6060447B2 (ja) | 2011-04-08 | 2017-01-18 | バイオ−ラッド ラボラトリーズ インコーポレーティッド | 非特異的活性が低下したSso7ポリメラーゼコンジュゲート |
US9394353B2 (en) | 2011-10-18 | 2016-07-19 | Csl Limited | Method for improving the stability of purified factor VIII after reconstitution |
CN102580062B (zh) * | 2012-03-09 | 2017-03-08 | 中国医学科学院输血研究所 | 人凝血因子VIII与vWF复合物或人凝血因子VIII制剂的干热处理稳定剂 |
JP2014138614A (ja) * | 2014-04-09 | 2014-07-31 | Sk Chemicals Co Ltd | 第viii因子とその誘導体の製造及び精製方法 |
EP3177317B1 (en) | 2014-08-04 | 2020-03-18 | CSL Limited | Factor viii formulation |
EP3994162A1 (en) | 2019-07-04 | 2022-05-11 | CSL Behring Lengnau AG | A truncated von willebrand factor (vwf) for increasing the in vitro stability of coagulation factor viii |
US20220380439A1 (en) | 2020-11-09 | 2022-12-01 | Takeda Pharmaceutical Company Limited | Purification of fviii from plasma using silicon oxide adsorption |
Family Cites Families (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB941019A (en) * | 1961-04-27 | 1963-11-06 | Crookes Lab Ltd | Improvements in and relating to the stability of anti-haemophilic globulin (factor viii) |
DE3176491D1 (en) * | 1980-03-05 | 1987-11-26 | Miles Lab | Pasteurized therapeutically active protein compositions |
US4650858A (en) * | 1983-03-21 | 1987-03-17 | Nordisk Gentofte A/S | Concentrate of the antihemophilic factor VIII and a process for producing it |
US4743680A (en) * | 1985-02-01 | 1988-05-10 | New York University | Method for purifying antihemophilic factor |
CA1329760C (en) * | 1987-10-29 | 1994-05-24 | Ted C. K. Lee | Plasma and recombinant protein formulations in high ionic strength media |
US4877608A (en) * | 1987-11-09 | 1989-10-31 | Rorer Pharmaceutical Corporation | Pharmaceutical plasma protein formulations in low ionic strength media |
FR2644064B1 (fr) * | 1989-02-17 | 1994-05-27 | Aquitaine Dev Transf Sanguine | Procede de fabrication du facteur antihemophilique fviiic ayant une tres haute purete et facteur antihemophilique fviiic ainsi obtenu, ainsi que composition pharmaceutique le contenant |
US5110907A (en) * | 1989-08-01 | 1992-05-05 | Alpha Therapeutic Corporation | Factor viii complex purification using heparin affinity chromatography |
DE3926034C3 (de) * | 1989-08-07 | 1996-11-21 | Behringwerke Ag | Verfahren zur Herstellung eines stabilen Faktors VIII |
DE4001451A1 (de) * | 1990-01-19 | 1991-08-01 | Octapharma Ag | Stabile injizierbare loesungen von faktor viii und faktor ix |
IT1248723B (it) * | 1990-06-12 | 1995-01-26 | Scalvo S P A | Processo per la purificazione del fattore viii e fattore viii ottenuto con tale processo |
JP4021982B2 (ja) * | 1998-03-03 | 2007-12-12 | 信越化学工業株式会社 | ハイブリッド型ウイグラ |
-
1991
- 1991-04-09 DE DE4111393A patent/DE4111393A1/de not_active Withdrawn
-
1992
- 1992-03-21 EP EP92104944A patent/EP0508194B1/de not_active Expired - Lifetime
- 1992-03-21 DE DE59209051T patent/DE59209051D1/de not_active Expired - Lifetime
- 1992-03-21 ES ES92104944T patent/ES2111579T4/es not_active Expired - Lifetime
- 1992-03-21 DK DK92104944T patent/DK0508194T3/da active
- 1992-03-21 AT AT92104944T patent/ATE160942T1/de active
- 1992-04-07 KR KR1019920005733A patent/KR100231398B1/ko not_active Expired - Lifetime
- 1992-04-08 JP JP08580692A patent/JP3777467B2/ja not_active Expired - Lifetime
- 1992-04-08 IE IE112492A patent/IE921124A1/en not_active IP Right Cessation
- 1992-04-08 AU AU14702/92A patent/AU651188B2/en not_active Expired
- 1992-04-08 CA CA002065553A patent/CA2065553C/en not_active Expired - Lifetime
-
1994
- 1994-04-29 US US08235241 patent/US5565427C1/en not_active Expired - Lifetime
-
1998
- 1998-01-14 GR GR980400046T patent/GR3025873T3/el unknown
-
2001
- 2001-07-23 JP JP2001220843A patent/JP3809501B2/ja not_active Expired - Lifetime
Also Published As
Publication number | Publication date |
---|---|
US5565427C1 (en) | 2002-07-23 |
AU651188B2 (en) | 1994-07-14 |
ES2111579T4 (es) | 2011-12-29 |
ATE160942T1 (de) | 1997-12-15 |
DE4111393A1 (de) | 1992-10-15 |
KR100231398B1 (ko) | 1999-11-15 |
DE59209051D1 (de) | 1998-01-22 |
CA2065553C (en) | 2003-06-10 |
JPH0597702A (ja) | 1993-04-20 |
JP3809501B2 (ja) | 2006-08-16 |
JP2002097199A (ja) | 2002-04-02 |
DK0508194T3 (da) | 1998-08-24 |
AU1470292A (en) | 1992-10-15 |
US5565427A (en) | 1996-10-15 |
JP3777467B2 (ja) | 2006-05-24 |
EP0508194B1 (de) | 1997-12-10 |
IE921124A1 (en) | 1992-10-21 |
ES2111579T3 (es) | 1998-03-16 |
CA2065553A1 (en) | 1992-10-10 |
EP0508194A1 (de) | 1992-10-14 |
GR3025873T3 (en) | 1998-04-30 |
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Patent event code: PA01091R01D Comment text: Patent Application Patent event date: 19920407 |
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Patent event code: PA02012R01D Patent event date: 19970131 Comment text: Request for Examination of Application Patent event code: PA02011R01I Patent event date: 19920407 Comment text: Patent Application |
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Patent event date: 19980217 Comment text: Notification of Change of Applicant Patent event code: PN23011R01D |
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Comment text: Notification of reason for refusal Patent event date: 19990129 Patent event code: PE09021S01D |
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