ATE460155T1 - Pharmazeutische zusammensetzung mit lyophilisiertem rekombinantem faktor viii ohne albumin als stabilisator - Google Patents

Pharmazeutische zusammensetzung mit lyophilisiertem rekombinantem faktor viii ohne albumin als stabilisator

Info

Publication number
ATE460155T1
ATE460155T1 AT05102880T AT05102880T ATE460155T1 AT E460155 T1 ATE460155 T1 AT E460155T1 AT 05102880 T AT05102880 T AT 05102880T AT 05102880 T AT05102880 T AT 05102880T AT E460155 T1 ATE460155 T1 AT E460155T1
Authority
AT
Austria
Prior art keywords
factor viii
recombinant factor
stabilizer
albumin
pharmaceutical composition
Prior art date
Application number
AT05102880T
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.)
Filing date
Publication date
Application filed by Green Cross Holdings filed Critical Green Cross Holdings
Application granted granted Critical
Publication of ATE460155T1 publication Critical patent/ATE460155T1/de

Links

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)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Epidemiology (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)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
AT05102880T 2004-06-25 2005-04-12 Pharmazeutische zusammensetzung mit lyophilisiertem rekombinantem faktor viii ohne albumin als stabilisator ATE460155T1 (de)

Applications Claiming Priority (1)

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

Publications (1)

Publication Number Publication Date
ATE460155T1 true ATE460155T1 (de) 2010-03-15

Family

ID=34511263

Family Applications (1)

Application Number Title Priority Date Filing Date
AT05102880T ATE460155T1 (de) 2004-06-25 2005-04-12 Pharmazeutische zusammensetzung mit lyophilisiertem rekombinantem faktor viii ohne albumin als stabilisator

Country Status (13)

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

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9084777B2 (en) 2005-12-28 2015-07-21 Chugai Seiyaku Kabushiki Kaisha Stabilized antibody-containing formulations
RU2011110459A (ru) 2008-08-21 2012-09-27 Октафарма АГ (CH) Рекомбинантно полученный человеческий фактор viii и ix
MX2011002316A (es) * 2008-09-03 2011-05-10 Octapharma Ag Nuevas composiciones protectoras para el factor viii producido de manera recombinante.
EP2726495B1 (de) * 2011-06-28 2019-03-06 Leukocare Ag Verfahren zum verhindern der entfaltung eines (poly)peptids und/oder induzieren der (neu)-faltung eines (poly)peptids
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
KR20160146763A (ko) 2014-04-01 2016-12-21 어드밴텍 바이오사이언스 파마큐티카 엘티디에이 부형제로서 칼슘이 첨가되지 않은 factor viii의 안정화
AU2015240353A1 (en) 2014-04-01 2016-11-17 Advantech Bioscience Farmaceutica Ltda. Stable Factor VIII formulations with low sugar-glycine
MX2017000862A (es) 2014-08-04 2017-05-01 Csl Ltd Formulacion de factor viii.
US20160265984A1 (en) * 2015-03-13 2016-09-15 Purdue Research Foundation Wireless sensors, systems, and methods thereof
EP3284480A4 (de) 2015-04-14 2018-12-05 Chugai Seiyaku Kabushiki Kaisha Pharmazeutische zusammensetzung zur prävention und/oder behandlung von atopischer dermatitis mit il-31-antagonisten als wirkstoff
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
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
US11604026B2 (en) 2019-03-14 2023-03-14 Terumo Bct Biotechnologies, Llc Lyophilization loading tray assembly and system
KR20220029733A (ko) 2019-07-04 2022-03-08 체에스엘 베링 렝나우 아게 응고 인자 viii의 시험관내 안정성을 증가시키기 위한 절단된 폰 빌레브란트 인자 (vwf)
AU2020387034A1 (en) 2019-11-20 2022-06-02 Chugai Seiyaku Kabushiki Kaisha Antibody-containing preparation
WO2022099223A2 (en) 2020-11-09 2022-05-12 Takeda Pharmaceutical Company Limited Purification of fviii from plasma using silicon oxide adsorption

Family Cites Families (17)

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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
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
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
BR0008405B1 (pt) * 1999-02-22 2014-04-22 Baxter Int Composição de fator viii formulada sem a adição de albumina, uso de uma composição de fator viii, e, método de liofilizar uma formulação farmacêutica aquosa
DE60115613T2 (de) * 2000-03-22 2006-08-24 Octagene Gmbh Herstellung von rekombinanten muteine des blutgerinnungsfaktors viii in humanen zellinien
FR2857267B1 (fr) * 2003-07-09 2006-03-10 Lab Francais Du Fractionnement Formulation stabilisante et solubilisante pour les proteines cryoprecipitables.

Also Published As

Publication number Publication date
TWI285112B (en) 2007-08-11
CA2504377A1 (en) 2005-12-25
AU2005202673B2 (en) 2007-05-17
US6887852B1 (en) 2005-05-03
DE602005019853D1 (de) 2010-04-22
KR20050123356A (ko) 2005-12-29
PL1712223T3 (pl) 2010-08-31
AU2005202673A1 (en) 2006-01-12
EP1712223B1 (de) 2010-03-10
JP4119407B2 (ja) 2008-07-16
CN1712067A (zh) 2005-12-28
JP2006008650A (ja) 2006-01-12
KR100624013B1 (ko) 2006-09-19
CN1325116C (zh) 2007-07-11
TW200605909A (en) 2006-02-16
EP1712223A1 (de) 2006-10-18
DK1712223T3 (da) 2010-05-31
CA2504377C (en) 2011-09-20
ES2342404T3 (es) 2010-07-06

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