PL1712223T3 - Preparat farmaceutyczny rekombinowanego czynnika VIII zliofilizowany bez albuminy jako stabilizatora - Google Patents

Preparat farmaceutyczny rekombinowanego czynnika VIII zliofilizowany bez albuminy jako stabilizatora

Info

Publication number: PL1712223T3
Authority: PL; Poland
Prior art keywords: factor viii; recombinant factor; stabilizer; albumin; pharmaceutical preparation
Prior art date: 2004-06-25

Application number

PL05102880T

Other languages

English (en)

Inventor

Sang-Hoon Paik

Yong-Nam Shin

Jean-Man Kim

Jae-Wook Huh

Jung-Sik Lee

Ki-Sung Kwon

Ji-Hyun Chun

Original Assignee

Green Cross Holdings

Priority date (The priority date 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 date listed.)

2004-06-25

Filing date

2005-04-12

Publication date

2010-08-31

2005-04-12 Application filed by Green Cross Holdings filed Critical Green Cross Holdings

2010-08-31 Publication of PL1712223T3 publication Critical patent/PL1712223T3/pl

Links

108010054218 Factor VIII Proteins 0.000 title abstract 4
102000001690 Factor VIII Human genes 0.000 title abstract 4
229960000301 factor viii Drugs 0.000 title abstract 4
102000009027 Albumins Human genes 0.000 title abstract 2
108010088751 Albumins Proteins 0.000 title abstract 2
239000003381 stabilizer Substances 0.000 title abstract 2
239000000825 pharmaceutical preparation Substances 0.000 title 1
238000002360 preparation method Methods 0.000 abstract 3
WHUUTDBJXJRKMK-VKHMYHEASA-N L-glutamic acid Chemical compound OC(=O)[C@@H](N)CCC(O)=O WHUUTDBJXJRKMK-VKHMYHEASA-N 0.000 abstract 2
238000004108 freeze drying Methods 0.000 abstract 2
102100026735 Coagulation factor VIII Human genes 0.000 abstract 1
201000003542 Factor VIII deficiency Diseases 0.000 abstract 1
208000009292 Hemophilia A Diseases 0.000 abstract 1
101000911390 Homo sapiens Coagulation factor VIII Proteins 0.000 abstract 1
ODKSFYDXXFIFQN-BYPYZUCNSA-N L-arginine Chemical compound OC(=O)[C@@H](N)CCCN=C(N)N ODKSFYDXXFIFQN-BYPYZUCNSA-N 0.000 abstract 1
229930064664 L-arginine Natural products 0.000 abstract 1
235000014852 L-arginine Nutrition 0.000 abstract 1
AGPKZVBTJJNPAG-WHFBIAKZSA-N L-isoleucine Chemical compound CC[C@H](C)[C@H](N)C(O)=O AGPKZVBTJJNPAG-WHFBIAKZSA-N 0.000 abstract 1
229930182844 L-isoleucine Natural products 0.000 abstract 1
239000008280 blood Substances 0.000 abstract 1
210000004369 blood Anatomy 0.000 abstract 1
230000000694 effects Effects 0.000 abstract 1
229960002989 glutamic acid Drugs 0.000 abstract 1
229960000310 isoleucine Drugs 0.000 abstract 1
239000000203 mixture Substances 0.000 abstract 1
230000000087 stabilizing effect Effects 0.000 abstract 1
230000001225 therapeutic effect Effects 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
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- 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
- 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)
- 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

Landscapes

Health & Medical Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
Chemical & Material Sciences (AREA)
Medicinal Chemistry (AREA)
General Health & Medical Sciences (AREA)
Animal Behavior & Ethology (AREA)
Bioinformatics & Cheminformatics (AREA)
Pharmacology & Pharmacy (AREA)
Engineering & Computer Science (AREA)
Public Health (AREA)
Veterinary Medicine (AREA)
Organic Chemistry (AREA)
Hematology (AREA)
Epidemiology (AREA)
Proteomics, Peptides & Aminoacids (AREA)
Gastroenterology & Hepatology (AREA)
Zoology (AREA)
Immunology (AREA)
General Chemical & Material Sciences (AREA)
Toxicology (AREA)
Biochemistry (AREA)
Biophysics (AREA)
Genetics & Genomics (AREA)
Molecular Biology (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
Chemical Kinetics & Catalysis (AREA)
Diabetes (AREA)
Medicinal Preparation (AREA)
Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

PL05102880T 2004-06-25 2005-04-12 Preparat farmaceutyczny rekombinowanego czynnika VIII zliofilizowany bez albuminy jako stabilizatora PL1712223T3 (pl)

Applications Claiming Priority (2)

Application Number	Priority Date	Filing Date	Title
KR1020040047985A KR100624013B1 (ko)	2004-06-25	2004-06-25	동결건조된 알부민 비함유 재조합 사람 혈액응고 제 8인자 제제
EP05102880A EP1712223B1 (en)	2004-06-25	2005-04-12	Pharmaceutical preparation of recombinant factor VIII lyophilized without albumin as a stabilizer

Publications (1)

Publication Number	Publication Date
PL1712223T3 true PL1712223T3 (pl)	2010-08-31

Family

ID=34511263

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
PL05102880T PL1712223T3 (pl)	2004-06-25	2005-04-12	Preparat farmaceutyczny rekombinowanego czynnika VIII zliofilizowany bez albuminy jako stabilizatora

Country Status (13)

Country	Link
US (1)	US6887852B1 (pl)
EP (1)	EP1712223B1 (pl)
JP (1)	JP4119407B2 (pl)
KR (1)	KR100624013B1 (pl)
CN (1)	CN1325116C (pl)
AT (1)	ATE460155T1 (pl)
AU (1)	AU2005202673B2 (pl)
CA (1)	CA2504377C (pl)
DE (1)	DE602005019853D1 (pl)
DK (1)	DK1712223T3 (pl)
ES (1)	ES2342404T3 (pl)
PL (1)	PL1712223T3 (pl)
TW (1)	TWI285112B (pl)

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
WO2007074880A1 (ja)	2005-12-28	2007-07-05	Chugai Seiyaku Kabushiki Kaisha	抗体含有安定化製剤
MX2011001624A (es)	2008-08-21	2011-03-28	Octapharma Ag	Factor viii y ix humano producido en forma recombinante.
WO2010026186A1 (en) *	2008-09-03	2010-03-11	Octapharma Ag	New protecting compositions for recombinantly produced factor viii
EP2726495B1 (en) *	2011-06-28	2019-03-06	Leukocare Ag	Method for preventing the unfolding of a (poly)peptide and/or inducing the (re-)folding of a (poly)peptide
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
US9855319B2 (en)	2014-04-01	2018-01-02	Advantech Bioscience Farmacêutica Ltda	Stabilization of factor VIII without calcium as an excipient
JP2017509659A (ja) *	2014-04-01	2017-04-06	アドヴァンテック・バイオサイエンス・ファルマスーティカ・リミターダ	低糖−低グリシンの安定な第ｖｉｉｉ因子製剤
CN106687126B (zh) *	2014-08-04	2020-07-28	杰特有限公司	因子viii制剂
US20160265984A1 (en) *	2015-03-13	2016-09-15	Purdue Research Foundation	Wireless sensors, systems, and methods thereof
JP5954916B1 (ja)	2015-04-14	2016-07-20	中外製薬株式会社	Ｉｌ−３１アンタゴニストを有効成分として含有する、アトピー性皮膚炎の予防用及び／又は治療用医薬組成物
CN105348382B (zh) *	2015-12-05	2020-09-11	上海洲跃生物科技有限公司	一种高纯人凝血因子viii的制备方法
MX2019006444A (es)	2016-12-02	2019-10-30	Bioverativ Therapeutics Inc	Métodos de tratamiento de artropatía hemofílica utilizando factores de coagulación quiméricos.
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
CN107988292B (zh) *	2018-01-18	2023-12-26	江苏江山聚源生物技术有限公司	提高重组人源胶原蛋白稳定性的发酵工艺
CN108245669B (zh) *	2018-02-06	2022-03-18	昆明龙津药业股份有限公司	一种稳定的降纤酶注射剂及制备方法
PL3793588T3 (pl)	2018-05-18	2025-09-01	Bioverativ Therapeutics Inc.	Sposoby leczenia hemofilii a
CN113597532B (zh)	2019-03-14	2023-02-17	泰尔茂比司特生物技术有限公司	冻干容器填充固定装置、系统及使用方法
WO2021001522A1 (en)	2019-07-04	2021-01-07	CSL Behring Lengnau AG	A truncated von willebrand factor (vwf) for increasing the in vitro stability of coagulation factor viii
MX2022005654A (es)	2019-11-20	2022-06-22	Chugai Pharmaceutical Co Ltd	Preparacion que contiene anticuerpo.
JP2025512143A (ja)	2020-11-09	2025-04-17	武田薬品工業株式会社	酸化ケイ素吸着を使用する血漿からのｆｖｉｉｉの精製

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
DE2916711A1 (de) *	1979-04-25	1980-11-06	Behringwerke Ag	Blutgerinnungsfaktoren und verfahren zu ihrer herstellung
JPS5874617A (ja)	1981-10-28	1983-05-06	Green Cross Corp:The	人由来血液凝固第７因子含有水溶液の加熱処理方法
JPS6122022A (ja) *	1983-12-28	1986-01-30	Green Cross Corp:The	血漿蛋白の加熱処理方法
DE3622642A1 (de) *	1986-07-05	1988-01-14	Behringwerke Ag	Einkomponenten-gewebekleber sowie verfahren zu seiner herstellung
CA1292686C (en)	1986-10-27	1991-12-03	Ze'ev Shaked	Pharmaceutical compositions of recombinant interleukin-2 and formulation process
US5096885A (en)	1988-04-15	1992-03-17	Genentech, Inc.	Human growth hormone formulation
DE4001451A1 (de)	1990-01-19	1991-08-01	Octapharma Ag	Stabile injizierbare loesungen von faktor viii und faktor ix
WO1993022336A1 (en) *	1992-04-30	1993-11-11	Alpha Therapeutic Corporation	Improved solubilization and stabilization of factor viii complex
CA2124690C (en) *	1992-10-02	2007-09-11	Thomas Osterberg	Composition comprising coagulation factor viii formulation, process for its preparation and use of a surfactant as stabilizer
US5686419A (en) *	1994-01-21	1997-11-11	Georgia Tech Research Corp.	Basic α-aminoalkylphosphonate derivatives
GB9501040D0 (en)	1995-01-19	1995-03-08	Quadrant Holdings Cambridge	Dried composition
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
AUPO871997A0 (en) *	1997-08-25	1997-09-18	Csl Limited	Dried biologically or therapeutically active preparations
DK1820516T3 (da) *	1999-02-22	2013-10-28	Univ Connecticut	Nye albuminfrie faktor VIII-præparater
EE200200538A (et) *	2000-03-22	2004-04-15	Octagene Gmbh	Rekombinantsete verehüübimisfaktorite produtseerimine inimese rakuliinides
FR2857267B1 (fr) *	2003-07-09	2006-03-10	Lab Francais Du Fractionnement	Formulation stabilisante et solubilisante pour les proteines cryoprecipitables.

2004
- 2004-06-25 KR KR1020040047985A patent/KR100624013B1/ko not_active Expired - Lifetime
- 2004-08-06 US US10/912,167 patent/US6887852B1/en not_active Expired - Lifetime
- 2004-08-16 JP JP2004236562A patent/JP4119407B2/ja not_active Expired - Fee Related
- 2004-10-20 CN CNB2004100869047A patent/CN1325116C/zh not_active Expired - Lifetime
2005
- 2005-04-12 AT AT05102880T patent/ATE460155T1/de active
- 2005-04-12 ES ES05102880T patent/ES2342404T3/es not_active Expired - Lifetime
- 2005-04-12 DK DK05102880.1T patent/DK1712223T3/da active
- 2005-04-12 PL PL05102880T patent/PL1712223T3/pl unknown
- 2005-04-12 DE DE602005019853T patent/DE602005019853D1/de not_active Expired - Lifetime
- 2005-04-12 EP EP05102880A patent/EP1712223B1/en not_active Expired - Lifetime
- 2005-04-14 CA CA2504377A patent/CA2504377C/en not_active Expired - Fee Related
- 2005-06-20 AU AU2005202673A patent/AU2005202673B2/en not_active Ceased
- 2005-06-22 TW TW094120786A patent/TWI285112B/zh not_active IP Right Cessation

Also Published As

Publication number	Publication date
KR100624013B1 (ko)	2006-09-19
DE602005019853D1 (de)	2010-04-22
JP4119407B2 (ja)	2008-07-16
TW200605909A (en)	2006-02-16
CN1712067A (zh)	2005-12-28
CA2504377C (en)	2011-09-20
TWI285112B (en)	2007-08-11
US6887852B1 (en)	2005-05-03
KR20050123356A (ko)	2005-12-29
CN1325116C (zh)	2007-07-11
DK1712223T3 (da)	2010-05-31
AU2005202673B2 (en)	2007-05-17
CA2504377A1 (en)	2005-12-25
EP1712223A1 (en)	2006-10-18
JP2006008650A (ja)	2006-01-12
ATE460155T1 (de)	2010-03-15
ES2342404T3 (es)	2010-07-06
EP1712223B1 (en)	2010-03-10
AU2005202673A1 (en)	2006-01-12

Publication	Publication Date	Title
PL1712223T3 (pl)	2010-08-31	Preparat farmaceutyczny rekombinowanego czynnika VIII zliofilizowany bez albuminy jako stabilizatora
CY1107584T1 (el)	2013-03-13	Μεθοδοι και συνθεσεις για την προληψη και θepαπεια της αναιμιας
CY1108154T1 (el)	2014-02-12	Μεθοδοι καi συνθεσεις για την προληψη και τη θεραπεiα της αναιμιας
JP2005527470A5 (pl)	2006-10-05
BRPI0407001A (pt)	2006-01-10	Método para aumentar a estabilidade de uma proteìna purificada, uso de uma proteìna ligante sìtio-especìfica ativa, método para aumentar a produção de uma proteìna recombinante e composição farmacêutica
EP1626055A3 (en)	2006-03-08	Non-mammalian GnRH analogs and uses thereof in the regulation of the immune system
DK1715887T3 (da)	2007-09-17	N-terminalt monopegyleret humant væksthormonkonjugater, fremgangsmåde til deres fremstilling og anvendelsen deraf
DE602004029038D1 (de)	2010-10-21	Hip/pap polypeptide zusammensetzung zur verwendung zur leberregeneration und zur vorbeugung von leberinsuffizienz
RU2013139651A (ru)	2015-03-10	Новые соединения, влияющие на пищевое поведение
DK1677833T3 (da)	2010-05-17	Virusvektor til anvendelse til in vivo-genterapi af Parkinsons sygdom
WO2002043746A3 (en)	2002-08-08	Compounds with the biological activity of vasoactive intestinal peptide for the treatment of pulmonary and arteriolar hypertension
UA82998C2 (ru)	2008-06-10	Экспрессия генов в модифицированном вирусе коровьей оспы ankara с использованием коровьего поксвирусного промотора аті
BRPI0413186A (pt)	2006-10-03	composição de fexofenadina e processo para preparação da mesma
CA2470656A1 (en)	2003-07-31	Corticotropin releasing factor 2 receptor agonists
WO2003063780A3 (en)	2004-11-11	Therapeutic composition for treatment of cancer by arginine depletion
MX2022008748A (es)	2022-12-07	Administración oral de péptidos.
CA2531419C (fr)	2014-12-23	Procede de stabilisation d'un cryoprecipite de proteines plasmatiques destine a etre soumis a un traitement thermique d'inactivation virale
NZ602479A (en)	2013-05-31	Pharmaceutical composition for the treatment of dry eye and/or corneal and conjunctival lesion
DE60333821D1 (de)	2010-09-30	Stabilisierte albumin-zubereitungen
CN102065844A (zh)	2011-05-18	干燥转谷氨酰胺酶组合物
DK1341813T3 (da)	2007-01-15	Anvendelse af L-carnitin som stabiliseringsmiddel af proteiner
DE60036199D1 (de)	2007-10-11	Proteaseresistente flint-analoge
JP2022536477A5 (pl)	2023-06-16
ATE505483T1 (de)	2011-04-15	Derivate des biologisch aktiven peptids vapeehptllteaplnpk
JP2007533728A (ja)	2007-11-22	ウイルス感染を治療するためのｈａｍｌｅｔ（腫瘍細胞に致死的なヒトアルファ−ラクトアルブミン）の使用