DK2193809T3 - Albumin-frie faktor-VIII-formuleringer - Google Patents

Albumin-frie faktor-VIII-formuleringer Download PDF

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Publication number
DK2193809T3
DK2193809T3 DK10075019.9T DK10075019T DK2193809T3 DK 2193809 T3 DK2193809 T3 DK 2193809T3 DK 10075019 T DK10075019 T DK 10075019T DK 2193809 T3 DK2193809 T3 DK 2193809T3
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DK
Denmark
Prior art keywords
factor viii
temperature
formulations
approx
naci
Prior art date
Application number
DK10075019.9T
Other languages
English (en)
Inventor
Marc Besman
Erik Bjornson
Ramesh Kashi
Michael Pikal
Serguei Tchessalov
John Carpenter
Feroz Jameel
Original Assignee
Univ Connecticut
Baxter Int
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.)
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=26944588&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK2193809(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Univ Connecticut, Baxter Int filed Critical Univ Connecticut
Application granted granted Critical
Publication of DK2193809T3 publication Critical patent/DK2193809T3/da

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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
    • A61K38/17—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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; 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
    • A61K9/0012—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
    • 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
    • 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
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Hematology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Diabetes (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Peptides Or Proteins (AREA)

Claims (15)

1. Fremgangsmåde til lyofilisering afen vandig farmaceutisk formulering indeholdende et krystalliserbart fyldstof og NaCI, hvor fremgangsmåden omfatter trinnene at: (a) fryse den vandige farmaceutiske formulering ved en temperatur på mindre end -30 °C; (b) hærde den farmaceutiske formulering ved mellem ca. -30 og -19°C; (c) sænke temperaturen af den farmaceutiske formulering til mindre end ca. -50°C; (d) hærde den farmaceutiske formulering ved mellem ca. -30 og -39°C; og derefter (e) frysetørre den farmaceutiske formulering.
2. Fremgangsmåden ifølge krav 1, hvor trin (a) gennemføres ved en temperatur på mindre end -35°C, fortrinsvis mindre end eller ca. -40°C.
3. Fremgangsmåden ifølge krav 1 eller 2, hvor trin (b) gennemføres i ca. 3 timer.
4. Fremgangsmåden ifølge et hvilket som helst af de foregående krav, hvor trin (c) gennemføres ved en temperatur på mindre end -55°C.
5. Fremgangsmåden ifølge et hvilket som helst af de foregående krav, hvor trin (c) gennemføres i ca. 1 time.
6. Fremgangsmåden ifølge et hvilket som helst af de foregående krav, hvor trin (d) gennemføres i ca. 4 timer.
7. Fremgangsmåden ifølge et hvilket som helst af de foregående krav, hvor det krystalliserbare fyldstof er mannitol. o. Fremgangsmaden ifølge krav 7, hvor trin (b) gennemføres vea en temperatur på mellem -21 og -24°C.
9. Fremgangsmåden ifølge krav 7 eller 8, hvor trin (d) gennemføres ved en temperatur på ca. -33°C.
10. Fremgangsmåden ifølge et hvilket som helst af kravene 1 til 6, hvor det krystalliserbare fyldstof er glycin.
11. Fremgangsmåden ifølge krav 10, hvor trin (b) gennemføres ved en temperatur på mellem -25 og -28°C.
12. Fremgangsmåden ifølge krav 10 eller 11, hvor trin (d) gennemføres ved en temperatur på ca. -36°C.
13. Fremgangsmåden ifølge et hvilket som helst af de foregående krav, hvor temperaturen af den farmaceutiske formulering efter trin (d) og før trin (e), sænkes til ca. -50°C, eventuelt i ca. 1 time.
14. Fremgangsmåden ifølge et hvilket som helst af de foregående krav, hvor trin (e) omfatter: (i) reducere trykket til ca. 65 mTorr; (ii) forhøje temperaturen til mellem ca. -32 og -35°C i op til 100 timer; (iii) forhøje temperaturen til +40°C i ca. 3 timer; (iv) forhøje temperaturen til ca. +45°C i ca. 3 timer; og (v) forhøje temperaturen til ca. +50°C i ca. 3 timer.
15. Fremgangsmåden ifølge et hvilket som helst af de foregående krav, hvor den farmaceutiske formulering omfatter Faktor VIII.
16. Fremgangsmaden ifølge krav 1, hvor den farmaceutiske formulering omfatter trehalose som stabiliseringsmiddel, fortrinsvis ved en koncentration på fra 1 til 4 % vægt/volumen af den vandige farmaceutiske formulering.
DK10075019.9T 1999-02-22 2000-02-22 Albumin-frie faktor-VIII-formuleringer DK2193809T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US25527999A 1999-02-22 1999-02-22
US45275299A 1999-12-01 1999-12-01
EP06077229.0A EP1820516B1 (en) 1999-02-22 2000-02-22 Novel albumin-free factor VIII formulations

Publications (1)

Publication Number Publication Date
DK2193809T3 true DK2193809T3 (da) 2015-05-26

Family

ID=26944588

Family Applications (4)

Application Number Title Priority Date Filing Date
DK06077229.0T DK1820516T3 (da) 1999-02-22 2000-02-22 Nye albuminfrie faktor VIII-præparater
DK09075396.3T DK2130554T3 (da) 1999-02-22 2000-02-22 Albuminfrie faktor VIII-præparater
DK10075019.9T DK2193809T3 (da) 1999-02-22 2000-02-22 Albumin-frie faktor-VIII-formuleringer
DK00907322T DK1154796T3 (da) 1999-02-22 2000-02-22 Nye albuminfrie Faktor VIII-formuleringer

Family Applications Before (2)

Application Number Title Priority Date Filing Date
DK06077229.0T DK1820516T3 (da) 1999-02-22 2000-02-22 Nye albuminfrie faktor VIII-præparater
DK09075396.3T DK2130554T3 (da) 1999-02-22 2000-02-22 Albuminfrie faktor VIII-præparater

Family Applications After (1)

Application Number Title Priority Date Filing Date
DK00907322T DK1154796T3 (da) 1999-02-22 2000-02-22 Nye albuminfrie Faktor VIII-formuleringer

Country Status (19)

Country Link
US (8) US6586573B1 (da)
EP (5) EP1820516B1 (da)
JP (9) JP5149470B2 (da)
CN (3) CN100553678C (da)
AT (1) ATE365052T1 (da)
AU (1) AU777972B2 (da)
BR (1) BR0008405B1 (da)
CA (4) CA2634663C (da)
CY (2) CY1108030T1 (da)
CZ (3) CZ307715B6 (da)
DE (1) DE60035260T2 (da)
DK (4) DK1820516T3 (da)
ES (4) ES2394755T3 (da)
HK (4) HK1133583A1 (da)
MX (1) MXPA01008515A (da)
PL (4) PL203893B1 (da)
PT (4) PT1820516E (da)
RU (1) RU2244556C2 (da)
WO (1) WO2000048635A1 (da)

Families Citing this family (127)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
US6214054B1 (en) 1998-09-21 2001-04-10 Edwards Lifesciences Corporation Method for fixation of biological tissues having mitigated propensity for post-implantation calcification and thrombosis and bioprosthetic devices prepared thereby
JP5149470B2 (ja) * 1999-02-22 2013-02-20 バクスター・インターナショナル・インコーポレイテッド 新規のアルブミンを含有していない第ｖｉｉｉ因子処方物
US6830917B2 (en) * 2001-12-10 2004-12-14 Baxter Healthcare S.A. Method of isolation and purification of trypsin from pronase protease and use thereof
BR0215216A (pt) * 2001-12-21 2004-11-16 Novo Nordisk Healthcare Ag Composição aquosa lìquida, método para preparar uma composição aquosa lìquida de um polipeptìdeo de fator vii, uso de uma composição aquosa lìquida, e, método para o tratamento de uma sìndrome de resposta ao fator vii
KR20040065278A (ko) * 2001-12-21 2004-07-21 노보 노르디스크 에이/에스 변경된 인자 ⅶ 폴리펩티드의 액체 조성물
US6878168B2 (en) 2002-01-03 2005-04-12 Edwards Lifesciences Corporation Treatment of bioprosthetic tissues to mitigate post implantation calcification
US6982080B2 (en) * 2002-03-15 2006-01-03 Wyeth Hydroxyethyl starch—containing polypeptide compositions
GB0207092D0 (en) 2002-03-26 2002-05-08 Sod Conseils Rech Applic Stable pharmaceutical composition containing factor VIII
US20040009918A1 (en) * 2002-05-03 2004-01-15 Hanne Nedergaard Stabilised solid compositions of modified factor VII
BRPI0311959B8 (pt) 2002-06-21 2021-05-25 Novo Nordisk Healthcare Ag composição, métodos para preparar um polipeptídeo estável do fator vii, e para tratar uma síndrome responsiva do fator vii, e, uso do polipeptídeo do fator vii
GB0304636D0 (en) * 2003-02-28 2003-04-02 Britannia Pharmaceuticals Ltd Pharmaceutical composition for nasal delivery
MXPA05009914A (es) * 2003-03-18 2006-01-09 Novo Nordisk Healthcare Ag Composiciones farmaceuticas acuosas, liquidas de polipeptidos del factor vii.
US7897734B2 (en) * 2003-03-26 2011-03-01 Novo Nordisk Healthcare Ag Method for the production of proteins
KR20060015574A (ko) * 2003-05-23 2006-02-17 노보 노르디스크 헬스 케어 악티엔게젤샤프트 용액 중 단백질 안정화
WO2004112828A1 (en) * 2003-06-25 2004-12-29 Novo Nordisk Health Care Ag Liquid composition of factor vii polypeptides
WO2005002615A1 (en) * 2003-07-01 2005-01-13 Novo Nordisk Health Care Ag Liquid, aqueous pharmaceutical composition of factor vii polypeptides
DE10333317A1 (de) * 2003-07-22 2005-02-17 Biotecon Therapeutics Gmbh Formulierung für Proteinarzneimittel ohne Zusatz von humanem Serumalbumin (HSA)
EP2264065B1 (en) * 2003-08-05 2017-03-08 Novo Nordisk A/S Novel insulin derivatives
KR100560697B1 (ko) * 2003-08-06 2006-03-16 씨제이 주식회사 알부민을 함유하지 않는 에리스로포이에틴 제제
CN102872451A (zh) * 2003-08-14 2013-01-16 诺和诺德医疗保健公司 因子vii多肽类的含水液体药物组合物
AU2004274430A1 (en) * 2003-09-12 2005-03-31 Antigenics, Inc. Vaccine for treatment and prevention of herpes simplex virus infection
KR20150138427A (ko) * 2003-12-19 2015-12-09 노보 노르디스크 헬스 케어 악티엔게젤샤프트 인자 ｖｉｉ 폴리펩티드의 안정화된 조성물
GB0404586D0 (en) * 2004-03-01 2004-04-07 Britannia Pharmaceuticals Ltd Improvements in or relating to organic materials
JP2007526329A (ja) * 2004-03-04 2007-09-13 ワイス 賦形剤の結晶化を改善するための凍結乾燥法
EP1755652B1 (en) * 2004-03-19 2010-11-24 Baxter International Inc. Factor ixa for the treatment of bleeding disorders
US7319032B2 (en) * 2004-04-22 2008-01-15 Medtox Non-sugar sweeteners for use in test devices
KR100624013B1 (ko) * 2004-06-25 2006-09-19 주식회사 녹십자홀딩스 동결건조된 알부민 비함유 재조합 사람 혈액응고 제 8인자 제제
US7884075B2 (en) 2004-12-27 2011-02-08 Baxter International Inc. Polymer-factor VIII-von Willebrand factor-conjugates
FR2881139A1 (fr) * 2005-01-26 2006-07-28 Agronomique Inst Nat Rech Composition pour la lyophilisation de proteines
US7956160B2 (en) * 2005-07-22 2011-06-07 Amgen Inc. Concentrated protein lyophilates, methods, and uses
PE20110803A1 (es) 2005-11-01 2011-11-07 Wyeth Corp Solucion de cloruro de sodio para reconstitucion o dilucion de farmaco
WO2007055393A1 (en) * 2005-11-09 2007-05-18 Ajinomoto Co., Inc. Kokumi-imparting agent
US8420144B2 (en) * 2005-11-09 2013-04-16 Ajinomoto Co., Inc. Kokumi-imparting agent, method of using, and compositions containing same
WO2007055388A2 (en) 2005-11-09 2007-05-18 Ajinomoto Co., Inc. Calcium receptor activator
RU2008118166A (ru) * 2005-11-22 2009-12-27 Вайет (Us) Составы, содержащие гибридные белки, включающие иммуноглобулин
CN101389650B (zh) 2005-12-28 2012-10-10 诺沃-诺迪斯克有限公司 包含酰化胰岛素和锌的组合物以及制备所述组合物的方法
US7985839B2 (en) 2006-03-31 2011-07-26 Baxter International Inc. Factor VIII polymer conjugates
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
KR20080108147A (ko) 2006-03-31 2008-12-11 백스터 인터내셔널 인코포레이티드 페질화된 인자 ｖｉｉｉ
EP2029740B1 (en) * 2006-05-31 2012-06-20 Genzyme Corporation Use of polysaccharides for promotion of enzymatic activity
CN103933612B (zh) 2006-10-27 2016-06-22 爱德华兹生命科学公司 用于外科植入的生物组织
EP2851087B1 (en) * 2006-11-07 2017-04-19 Sanofi Pasteur Biologics, LLC Stabilization of vaccines by lyophilization
ES2521490T3 (es) 2006-12-15 2014-11-12 Baxter International Inc. Conjugado de factor VIIa - ácido (poli)siálico con una vida media in vivo prolongada.
FR2913020B1 (fr) 2007-02-23 2012-11-23 Biomethodes Nouveaux facteurs viii pour le traitement des hemophiles de type a
ATE512660T1 (de) * 2007-03-05 2011-07-15 Cadila Healthcare Ltd Zusammensetzungen mit peg-interferon-alpha- konjugaten und raffinose als kryoschutzmittel
RU2469739C2 (ru) 2007-04-26 2012-12-20 БАЙЕР ХЕЛСКЕА ЛЛСи Стабилизация жидких растворов рекомбинантного белка для хранения в замороженном состоянии
AU2013204652B2 (en) * 2007-04-26 2015-06-18 Bayer Healthcare Llc Stabilization of liquid solutions of recombinant protein for frozen storage
NZ581627A (en) * 2007-05-08 2012-07-27 Ajinomoto Kk Low fat food with a calcium receptor activating additive
US9101691B2 (en) 2007-06-11 2015-08-11 Edwards Lifesciences Corporation Methods for pre-stressing and capping bioprosthetic tissue
WO2008152106A1 (en) * 2007-06-13 2008-12-18 Novo Nordisk A/S Pharmaceutical formulation comprising an insulin derivative
GB0715285D0 (en) * 2007-08-06 2007-09-12 Britannia Pharmaceuticals Ltd Improvements in or relating to powdered medicaments for nasal delivery
CN101376022B (zh) * 2007-08-31 2011-11-30 上海医药工业研究院 含聚乙二醇降纤酶的药物组合物
US8357387B2 (en) 2007-12-21 2013-01-22 Edwards Lifesciences Corporation Capping bioprosthetic tissue to reduce calcification
PT2222315E (pt) * 2007-12-21 2013-07-16 Cangene Corp Formulações de fator ix estabilizadas contendo trealose
US9359629B2 (en) 2007-12-27 2016-06-07 Baxalta Incorporated Cell culture processes
EP2113564A1 (en) * 2008-05-01 2009-11-04 Arecor Limited Protein formulation
EP2323629B1 (en) * 2008-08-05 2019-10-09 Wyeth LLC Lyophilization above collapse
RU2011110459A (ru) 2008-08-21 2012-09-27 Октафарма АГ (CH) Рекомбинантно полученный человеческий фактор viii и ix
EP2331078B1 (en) * 2008-08-27 2012-09-19 Merck Sharp & Dohme Corp. Lyophilized formulations of engineered anti-il-23p19 antibodies
ES2382443T3 (es) * 2008-09-03 2012-06-08 Octapharma Ag Composiciones estabilizadas para factor VIII producido de manera recombinante
MX2011002372A (es) * 2008-09-10 2011-04-04 Genentech Inc Composiciones y metodos para la prevencion de la degradacion oxidativa de proteinas.
ES2607003T3 (es) * 2008-10-30 2017-03-28 Novo Nordisk A/S Tratamiento de diabetes mellitus utilizando inyecciones de insulina con una frecuencia de inyección inferior a la diaria
NZ593190A (en) * 2008-11-07 2013-01-25 Baxter Int Factor viii formulations
EP2248518B1 (en) * 2009-04-17 2013-01-16 Merz Pharma GmbH & Co. KGaA Formulation for stabilizing proteins, peptides or mixtures thereof.
US8809501B2 (en) 2009-07-27 2014-08-19 Baxter International Inc. Nucleophilic catalysts for oxime linkage
US8642737B2 (en) 2010-07-26 2014-02-04 Baxter International Inc. Nucleophilic catalysts for oxime linkage
ES2590679T3 (es) 2009-07-27 2016-11-23 Lipoxen Technologies Limited Glicopolisialilación de proteínas diferentes a proteínas de coagulación de la sangre
SG10201401194VA (en) 2009-07-27 2014-07-30 Lipoxen Technologies Ltd Glycopolysialylation of non-blood coagulation proteins
KR101832937B1 (ko) 2009-07-27 2018-02-28 박스알타 인코퍼레이티드 혈액 응고 단백질 복합체
GB0915480D0 (en) * 2009-09-04 2009-10-07 Arecor Ltd Stable formulation of factor viii
JP5819303B2 (ja) 2009-09-21 2015-11-24 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 安定化された液体および凍結乾燥ａｄａｍｔｓ１３製剤
EP2496246B1 (en) 2009-11-03 2018-06-27 Grifols Therapeutics LLC Composition, method, and kit for alpha-1 proteinase inhibitor
JP5810091B2 (ja) * 2009-11-24 2015-11-11 グリフオルス・セラピユーテイクス・インコーポレーテツドＧｒｉｆｏｌｓ Ｔｈｅｒａｐｅｕｔｉｃｓ，Ｉｎｃ． 凍結乾燥方法、組成物、及びキット
US8829163B2 (en) * 2010-01-19 2014-09-09 Hanmi Science Co., Ltd Liquid formulations for long-acting erythropoietin conjugate
CA2794121C (en) 2010-03-23 2016-10-11 Edwards Lifesciences Corporation Methods of conditioning sheet bioprosthetic tissue
US8906601B2 (en) 2010-06-17 2014-12-09 Edwardss Lifesciences Corporation Methods for stabilizing a bioprosthetic tissue by chemical modification of antigenic carbohydrates
WO2011160085A2 (en) 2010-06-17 2011-12-22 Edwards Lifesciences Corporation Methods for stabilizing a bioprosthetic tissue by chemical modification of antigenic carbohydrates
JP6055412B2 (ja) * 2010-09-17 2016-12-27 バクスアルタ ゲーエムベーハー 弱酸性〜中性のｐＨにおける、ヒスチジンを有する水性製剤を介した免疫グロブリンの安定化
JP5990176B2 (ja) * 2010-10-12 2016-09-07 メルツ ファーマ ゲゼルシャフト ミット ベシュレンクテル ハフツング ウント コンパニー コマンディト ゲゼルシャフト アウフ アクティーン タンパク質の安定化に好適な哺乳動物性賦形剤非含有製剤
BR112013010345A2 (pt) 2010-10-27 2017-07-25 Novo Nordisk As tratamento de diabetes melitus usando as injeções de insulina administradas com intervalos de variação da injeção
MX347503B (es) 2010-11-05 2017-04-26 Baxalta Inc Una variante nueva del factor viii antihemofílico que tiene actividad específica incrementada.
US9351829B2 (en) 2010-11-17 2016-05-31 Edwards Lifesciences Corporation Double cross-linkage process to enhance post-implantation bioprosthetic tissue durability
WO2012079979A1 (en) * 2010-12-16 2012-06-21 Novo Nordisk A/S Aqueous factor viii solution
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)
BRPI1105317A2 (pt) 2011-01-24 2013-04-30 Fundacco Hemoct De Ribeirco Preto produÇço estÁvel e em larga escala de fviii humano em linhagem celular humana sk-hep-1
MX341076B (es) 2011-03-31 2016-08-04 Merck Sharp & Dohme Formulaciones estables de anticuerpos para el receptor humano pd-1 de meurte programada y tratamientos relacionados.
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
EP2694684B1 (en) 2011-04-08 2017-05-31 Bio-Rad Laboratories, Inc. Sso7-polymerase conjugates with decreased non-specific activity
US20140227250A1 (en) 2012-08-23 2014-08-14 Merck Sharp & Dohme Corp. Stable formulations of antibodies to tslp
US10238771B2 (en) 2012-11-08 2019-03-26 Edwards Lifesciences Corporation Methods for treating bioprosthetic tissue using a nucleophile/electrophile in a catalytic system
US20160030524A1 (en) * 2013-03-15 2016-02-04 Bayer Healthcare Llc Recombinant factor viii formulations
JP6330026B2 (ja) * 2013-03-15 2018-05-23 バイオベラティブ セラピューティクス インコーポレイテッド 第ｖｉｉｉ因子ポリペプチド製剤
US9839579B2 (en) 2013-04-24 2017-12-12 Corning Incorporated Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients
US9700486B2 (en) 2013-04-24 2017-07-11 Corning Incorporated Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients
EP2991672A1 (en) 2013-04-30 2016-03-09 Novo Nordisk A/S Novel administration regime
KR102058864B1 (ko) * 2013-12-16 2019-12-24 주식회사 티움바이오 인자 vii의 융합 단백질을 포함하는 안정성이 개선된 약학적 조성물
EP3126003A4 (en) 2014-04-01 2017-11-29 Advantech Bioscience Farmacêutica Ltda. Stable factor viii formulations with low sugar-glycine
MX2016012869A (es) 2014-04-01 2017-05-12 Advantech Bioscience Farmacêutica Ltda Estabilizacion del factor viii sin calcio como un excipiente.
DK3177317T3 (en) * 2014-08-04 2020-06-15 Csl Ltd Factor viii formulation
EA202091385A3 (ru) * 2014-08-20 2021-06-30 Портола Фармасьютикалз, Инк. Лиофилизированные составы для антидота фактора ха
IL251834B2 (en) * 2014-10-23 2023-09-01 Ngm Biopharmaceuticals Inc Pharmaceutical compositions containing peptide variants and methods of using them
ES2893239T3 (es) 2015-04-21 2022-02-08 Staidson Beijing Biopharmaceuticals Co Ltd Composición de factor de crecimiento nervioso y polvo de inyección
EP3287140B1 (en) 2015-04-21 2021-06-02 Staidson (Beijing) Biopharmaceuticals Co., Ltd. Nerve growth factor composition and powder injection
WO2017007837A1 (en) * 2015-07-07 2017-01-12 Nanobio Corporation Methods and compositions for the stabilizaton of proteins
US11173197B2 (en) 2015-07-07 2021-11-16 Bluewillow Biologics, Inc. Methods and compositions for nanoemulsion vaccine formulations
US10287338B2 (en) 2015-07-10 2019-05-14 Miran NERSISSIAN Factor VIII protein compositions and methods of treating of hemophilia A
EP3167877A1 (en) * 2015-11-12 2017-05-17 Bayer Pharma Aktiengesellschaft Method for the production of freeze-dried pellets comprising factor viii
ES2884119T3 (es) * 2016-02-24 2021-12-10 Alexion Pharma Inc Fórmulas liofilizadas para antídoto contra el factor Xa
MX2018014916A (es) * 2016-06-01 2019-07-18 Servier Ip Uk Ltd Formulaciones de oxido de polialquileno-asparaginasa y metodos de preparacion y uso del mismo.
DE112016007531T5 (de) * 2016-12-21 2019-11-21 Chung Chin SUN Neues verfahren zum blutplasmaprotein-aktivitätserhalt
BR112019022873A8 (pt) 2017-05-02 2023-04-11 Merck Sharp & Dohme Formulação, e, vaso ou dispositivo de injeção.
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
JP6630315B2 (ja) 2017-06-27 2020-01-15 矢崎総業株式会社 ノイズ低減ユニット
US10335464B1 (en) 2018-06-26 2019-07-02 Novo Nordisk A/S Device for titrating basal insulin
AU2020204922A1 (en) * 2019-01-06 2021-07-01 Endo Global Aesthetics Limited Collagenase formulations and methods of producing the same
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
CN110772487B (zh) * 2019-12-09 2021-09-21 湖南科伦制药有限公司 一种二乙酰氨乙酸乙二胺的冻干方法
CA3192509A1 (en) 2020-09-24 2022-03-31 Yogita Krishnamachari Stable formulations of programmed death receptor 1 (pd-1) antibodies and hyaluronidase variants and fragments thereof and methods of use thereof
CN112121009B (zh) * 2020-09-24 2022-12-02 科兴生物制药股份有限公司 一种聚乙二醇修饰重组人粒细胞刺激因子新制剂
CN116322920A (zh) 2020-11-09 2023-06-23 武田药品工业株式会社 使用氧化硅吸附从血浆中纯化fviii
WO2022217041A1 (en) * 2021-04-09 2022-10-13 Hyalo Technologies, LLC Method of sterilization of biologics
JP2024528312A (ja) * 2021-08-11 2024-07-26 グリフォルス・ワールドワイド・オペレーションズ・リミテッド ヒト血漿由来第ｖｉｉｉ因子／フォンヴィレブラント因子の製造方法および得られた組成物
CN114015758B (zh) * 2021-10-15 2022-06-24 无锡百泰克生物技术有限公司 一种冻干保护剂、荧光pcr检测试剂盒及冻干工艺

Family Cites Families (177)

* Cited by examiner, † Cited by third party
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)
US3389314A (en) 1962-05-07 1968-06-18 Penn Controls Proportional silicon controlled rectifier driven system for a heat motor
US3681126A (en) 1969-11-25 1972-08-01 Monsanto Co Flame retardant article containing tris-(3 - halo - 2-hydroxypropyl)-hydroxymethylphosphonium chloride
US3839314A (en) * 1971-06-29 1974-10-01 Baxter Laboratories Inc Clarification of blood serum and plasma using block copolymers of ethylene oxide and polyoxypropylene
US3770631A (en) 1971-06-29 1973-11-06 Baxter Laboratories Inc Clarification of blood serum and plasma
US4073886A (en) 1973-01-30 1978-02-14 Baxter Travenol Laboratories, Inc. Blood fractionation process using block copolymers of ethylene oxide and polyoxypropylene
US3980432A (en) 1973-04-02 1976-09-14 Behringwerke Aktiengesellschaft Partial thromboplastin, its use as diagnostic agent and process for preparing it
US3893991A (en) 1973-04-05 1975-07-08 Baxter Laboratories Inc Clarification of blood serum and plasma using block copolymers of ethylene oxide and polyoxypropylene
US3893990A (en) 1973-04-05 1975-07-08 Baxter Laboratories Inc Clarification of blood serum and plasma using a block copolymer of ethylene oxide and polyoxypropylene
US4189425A (en) 1975-04-11 1980-02-19 Edward Shanbrom, Inc. Method of preserving blood plasma I
US4105650A (en) 1975-04-11 1978-08-08 Edward Shanbrom, Inc. Method of preserving blood plasma i
US4069216A (en) 1975-06-16 1978-01-17 Edward Shanbrom, Inc. Simplified methods for preparation of very high purity Factor VIII concentrate
US4089944A (en) 1975-12-22 1978-05-16 Baxter Travenol Laboratories, Inc. Rapidly solubilized AHF composition and process for preparing same
US4027013A (en) 1976-01-22 1977-05-31 William L. Wilson Clottable fibrinogen free factor VIII and albumin product and process
SU663404A1 (ru) 1976-12-30 1979-05-25 Московский Ордена Ленина И Ордена Трудового Красного Знамени Государственный Университет Им. М.В.Ломоносова Способ получени фибрин-мономера
US4137223A (en) 1977-05-16 1979-01-30 Edward Shanbrom, Inc. Method of preserving blood plasma II
SE443293B (sv) 1978-01-25 1986-02-24 Blombaeck E G B Blodfraktionsframstellning
DE2916711A1 (de) 1979-04-25 1980-11-06 Behringwerke Ag Blutgerinnungsfaktoren und verfahren zu ihrer herstellung
US4783441A (en) 1979-04-30 1988-11-08 Hoechst Aktiengesellschaft Aqueous protein solutions stable to denaturation
FR2460305A2 (fr) 1979-06-29 1981-01-23 Merieux Inst Procede de preparation d'un concentre de facteur viii
US4386068A (en) 1980-02-26 1983-05-31 Cutter Laboratories, Inc. Antihemophilic factor concentrate and method for preparation
US4623717A (en) 1980-03-05 1986-11-18 Miles Laboratories, Inc. Pasteurized therapeutically active protein compositions
US4341764A (en) 1980-03-05 1982-07-27 Cutter Laboratories, Inc. Method of preparing fibronectin and antihemophilic factor
EP0035204B2 (en) 1980-03-05 1991-05-22 Miles Inc. Pasteurized therapeutically active protein compositions
US4440679A (en) 1980-03-05 1984-04-03 Cutter Laboratories, Inc. Pasteurized therapeutically active protein compositions
JPS56127308A (en) 1980-03-11 1981-10-06 Green Cross Corp:The Blood-coagulation factor 8 pharmaceutical
JPS56135418A (en) 1980-03-27 1981-10-22 Green Cross Corp:The Heat treatment of aqueous solution containing 8 factor of coagulation of blood derived from human
AT369263B (de) 1980-08-27 1982-12-27 Immuno Ag Verfahren zur herstellung eines faktor viii(ahf) -hochkonzentrates
DE3033932C2 (de) 1980-09-10 1984-05-24 Biotest-Serum-Institut Gmbh, 6000 Frankfurt Verfahren zur Kaltsterilisation von Blutgerinnungsfaktor VIII enthaltenden Präparaten
JPS5770814A (en) 1980-10-17 1982-05-01 Isamu Horikoshi Oral preparation of blood clotting eighth factor
US4495278A (en) 1981-04-27 1985-01-22 Baxter Travenol Laboratories, Inc. Process for making novel blood clotting enzyme compositions
US4479938A (en) 1981-06-25 1984-10-30 Baxter Travenol Laboratories, Inc. Therapeutic composition containing factor VIIa
US4382083A (en) 1981-06-25 1983-05-03 Baxter Travenol Laboratories, Inc. Therapeutic method for treating blood-clotting defects with factor VIIa
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
US4456590B2 (en) 1981-11-02 1989-05-30 Heat treatment of lyphilized blood clotting factor viii concentrate
US4591505A (en) 1982-04-14 1986-05-27 New York Blood Center, Inc. Process for inactivating hepatitis B virus
US4481189A (en) 1982-04-14 1984-11-06 New York Blood Center Inc. Process for preparing sterilized plasma and plasma derivatives
US4495175A (en) 1982-08-05 1985-01-22 University Of Rochester Preparation of highly purified human antihemophilic factor
DE3230849A1 (de) 1982-08-19 1984-02-23 Behringwerke Ag, 3550 Marburg Pasteurisiertes human-fibrinogen (hf) und verfahren zu dessen herstellung
DE3237512A1 (de) 1982-10-09 1984-04-12 Behringwerke Ag, 3550 Marburg Verfahren zur pasteurisierung von antihaemophilem kryopraezipitat (ahk) und danach hergestelltes antihaemophiles kryopraezipitat
GB2129685B (en) 1982-11-11 1985-11-13 Nat Biolog Standards Board Anti-haemophilic compositions
JPS59134730A (ja) 1983-01-20 1984-08-02 Green Cross Corp:The 血液凝固第８因子の加熱処理法
EP0148843B2 (en) 1983-03-21 1994-05-04 Novo Nordisk A/S A concentrate of the antihemophilic factor viii and a process for producing it
IE80858B1 (en) 1983-03-31 1999-04-21 Scripps Research Inst New factor viii coagulant polypeptides
US4727027A (en) 1983-05-02 1988-02-23 Diamond Scientific Co. Photochemical decontamination treatment of whole blood or blood components
US4748120A (en) 1983-05-02 1988-05-31 Diamond Scientific Co. Photochemical decontamination treatment of whole blood or blood components
AT379510B (de) 1983-05-20 1986-01-27 Immuno Ag Verfahren zur herstellung einer faktor viii (ahf) -haeltigen praeparation
DE3318521A1 (de) 1983-05-20 1984-11-22 Lentia GmbH Chem. u. pharm. Erzeugnisse - Industriebedarf, 8000 München Verfahren zur herstellung eines antihaemophiliefaktor-konzentrats
US4540573A (en) 1983-07-14 1985-09-10 New York Blood Center, Inc. Undenatured virus-free biologically active protein derivatives
DE3336631A1 (de) 1983-10-08 1985-04-18 Behringwerke Ag, 3550 Marburg Verfahren zur pasteurisierung von plasma oder von konzentraten der blutgerinnungsfaktoren ii, vii, ix und x
US4757006A (en) 1983-10-28 1988-07-12 Genetics Institute, Inc. Human factor VIII:C gene and recombinant methods for production
US4693981A (en) 1983-12-20 1987-09-15 Advanced Genetics Research Institute Preparation of inactivated viral vaccines
JPS6122022A (ja) 1983-12-28 1986-01-30 Green Cross Corp:The 血漿蛋白の加熱処理方法
DE3586402T3 (de) 1984-01-12 2004-12-23 Chiron Corp. (N.D.Ges.D. Staates Delaware), Emeryville Proteinzusammensetzung mit Koagulations-wirkung und Verfahren zu ihrer Herstellung.
AT389815B (de) 1984-03-09 1990-02-12 Immuno Ag Verfahren zur inaktivierung von vermehrungsfaehigen filtrierbaren krankheitserregern in blutprodukten
US4831012A (en) 1984-03-23 1989-05-16 Baxter International Inc. Purified hemoglobin solutions and method for making same
JPS60199829A (ja) 1984-03-24 1985-10-09 Nippon Sekijiyuujishiya 高純度抗血友病グロブリンの製造方法
US5043428A (en) 1984-08-31 1991-08-27 Behringwerke Aktiengesellschaft Pasteurized, isoagglutinin-free factor VIII preparation and a process for its production
US4543210A (en) 1984-10-04 1985-09-24 Miles Laboratories, Inc. Process for producing a high purity antihemophilic factor concentrate
US4613501A (en) 1984-12-21 1986-09-23 New York Blood Center, Inc. Inactivation of viruses in labile blood derivatives
JPS61271222A (ja) * 1985-05-24 1986-12-01 Dainippon Pharmaceut Co Ltd ヒトインターロイキン１ポリペプチド及びその製造法
US4847362A (en) 1985-02-01 1989-07-11 New York University Method for purifying antihemophilic factor
US4743680A (en) 1985-02-01 1988-05-10 New York University Method for purifying antihemophilic factor
US4952675A (en) 1985-02-01 1990-08-28 New York University Method for purifying antihemophilic factor
EP0218712B1 (en) 1985-04-12 1992-02-26 Genetics Institute, Inc. Novel procoagulant proteins
US4891319A (en) 1985-07-09 1990-01-02 Quadrant Bioresources Limited Protection of proteins and the like
US4758657A (en) 1985-07-11 1988-07-19 Armour Pharmaceutical Company Method of purifying Factor VIII:C
EP0212040B1 (de) 1985-08-05 1990-05-23 IMMUNO Aktiengesellschaft für chemisch-medizinische Produkte Verfahren zur Herstellung von Präparationen auf Basis von Blutgerinnungsfaktoren
CA1293941C (en) 1985-11-08 1992-01-07 Maria Erlinda Co-Sarno Method for preparing antihemophilic factor (ahf) by cold precipitation and for improving solubility of recovered ahf product
US5180583A (en) 1985-11-26 1993-01-19 Hedner Ulla K E Method for the treatment of bleeding disorders
JPS62195331A (ja) 1986-02-24 1987-08-28 Nippon Sekijiyuujishiya 血液凝固第８因子製剤の製法
AT390374B (de) 1986-03-18 1990-04-25 Schwab & Co Gmbh Verfahren zum pasteurisieren von plasmaprotein und plasmaproteinfraktionen
DE3609431A1 (de) 1986-03-20 1987-09-24 Biotest Pharma Gmbh Verfahren zur herstellung eines den blutgerinnungsfaktor viii enthaltenden, sterilen praeparates
US4841023A (en) 1986-06-25 1989-06-20 New York Blood Center, Inc. Inactivation of viruses in labile protein-containing compositions using fatty acids
AT391808B (de) 1986-11-03 1990-12-10 Immuno Ag Verfahren zur herstellung einer faktor viii (ahf)-haeltigen fraktion
GB8628104D0 (en) 1986-11-25 1986-12-31 Connaught Lab Pasteurization of immunoglobin solutions
CA1331157C (en) 1987-04-06 1994-08-02 Randal J. Kaufman Method for producing factor viii:c-type proteins
ES2006632A6 (es) 1987-04-21 1989-05-01 Green Cross Corp Procedimiento de tratamiento termico de fibrinogeno.
US4876241A (en) 1987-05-22 1989-10-24 Armour Pharmaceutical Company Stabilization of biological and pharmaceutical products during thermal inactivation of viral and bacterial contaminants
IL86417A (en) 1987-05-22 1992-09-06 Armour Pharma Process for the inactivation of pathogens in biological or pharmaceutical material by mixing with aqueous solution containing a sugar(alcohol)and neutral salts as stabilizers
US4795806A (en) 1987-07-16 1989-01-03 Miles Laboratories, Inc. Phospholipid affinity purification of Factor VIII:C
JPH0387173A (ja) 1987-09-10 1991-04-11 Teijin Ltd ヒト活性化天然型ファクター８ｃの製造方法及びそれに用いる形質転換体
DE3730533A1 (de) 1987-09-11 1989-03-30 Biotest Pharma Gmbh Verfahren zur sterilisation von plasma oder plasmafraktionen
KR890004724A (ko) * 1987-09-17 1989-05-09 히사시 미하라 신규 프로테아제 제제(製劑)
US5605884A (en) 1987-10-29 1997-02-25 Rhone-Poulenc Rorer Pharmaceuticals Inc. Factor VIII formulations in high ionic strength media
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
US5177191A (en) 1987-12-21 1993-01-05 Miles, Inc. Gel filtration of factor VIII
DK18288D0 (da) 1988-01-15 1988-01-15 Nordisk Gentofte Fremgangsmaade til pasteurisering af vandige oploesninger af faktor viii
WO1989009784A1 (en) 1988-04-08 1989-10-19 Commonwealth Serum Laboratories Commission Production of heat-stable factor viii concentrate
US4981951A (en) 1988-04-14 1991-01-01 Miles Inc. Lectin affinity chromatography of factor VIII
FR2632309B1 (fr) 1988-06-07 1990-08-24 Lille Transfusion Sanguine Procede de purification par voie chromatographique de proteines, notamment de facteur viii, et les produits obtenus
US5047249A (en) 1988-07-22 1991-09-10 John Morris Co., Inc. Compositions and methods for treating skin conditions and promoting wound healing
US5051353A (en) 1988-08-09 1991-09-24 The United States Of America As Represented By The Secretary Of The Navy Preservation and restoration of hemoglobin in blood substitutes
JPH02157231A (ja) * 1988-12-07 1990-06-18 Bio Kagaku Kenkyusho:Kk 細胞増殖抑制剤
DE3904354A1 (de) 1989-02-14 1990-08-16 Behringwerke Ag Pasteurisiertes, gereinigtes von willebrand-faktor-konzentrat und verfahren zu seiner herstellung
US5760183A (en) 1989-02-17 1998-06-02 Association D'aquitaine Pour De Developpment De La Transfusion Sanguine Et Des Recherches Hematologiques Process for the manufacture of very high-purity antithaemophilic factor (FVIIIC), and von Willebrand factor, and pharmaceutical compositions containing same
FR2665449B1 (fr) 1990-08-02 1995-04-14 Aquitaine Developp Transf Sang Procede de fabrication de facteur von willebrand ayant une tres haute purete, depourvu en majeure partie de facteur antihemophilique (fviiic), et facteur von willebrand ainsi obtenu, ainsi qu'une composition pharmaceutique le contenant.
CN1047342A (zh) 1989-05-13 1990-11-28 杭州市中心血站 因子viii的生产及其病毒灭活方法
EP0399321B1 (en) 1989-05-24 1993-06-23 Miles Inc. Gel filtration of heat treated factor viii
GB8913183D0 (en) * 1989-06-08 1989-07-26 Central Blood Lab Authority Chemical products
US5138034A (en) 1989-07-12 1992-08-11 The Green Cross Corporation Method of fractionating plasma proteins
US5062498A (en) 1989-07-18 1991-11-05 Jaromir Tobias Hydrostatic power transfer system with isolating accumulator
EP0410207B1 (en) 1989-07-24 1997-01-22 Bayer Corporation Stabilization of highly purified proteins
DE3926034C3 (de) 1989-08-07 1996-11-21 Behringwerke Ag Verfahren zur Herstellung eines stabilen Faktors VIII
FR2651437A1 (fr) 1989-09-05 1991-03-08 Lille Transfusion Sanguine Procede de preparation de concentre du complexe facteur viii-facteur von willebrand de la coagulation sanguine a partir de plasma total.
DK162233C (da) 1989-11-09 1992-03-16 Novo Nordisk As Fremgangsmaade til isolering af faktor viii fra blodplasma og pharmaceutisk praeparat indeholdende den saaledes isolerede fator viii
SE465222C5 (sv) 1989-12-15 1998-02-10 Pharmacia & Upjohn Ab Ett rekombinant, humant faktor VIII-derivat och förfarande för dess framställning
US5439882A (en) 1989-12-29 1995-08-08 Texas Tech University Health Sciences Center Blood substitute
DE4001451A1 (de) 1990-01-19 1991-08-01 Octapharma Ag Stabile injizierbare loesungen von faktor viii und faktor ix
US5587490A (en) 1990-04-16 1996-12-24 Credit Managers Association Of California Method of inactivation of viral and bacterial blood contaminants
US5418130A (en) 1990-04-16 1995-05-23 Cryopharm Corporation Method of inactivation of viral and bacterial blood contaminants
US5798238A (en) 1990-04-16 1998-08-25 Baxter International Inc. Method of inactivation of viral and bacterial blood contaminants with quinolines as photosensitizer
WO1991017194A1 (en) * 1990-05-07 1991-11-14 Exxon Chemical Patents Inc. UNSATURATED α-OLEFIN COPOLYMERS AND METHOD FOR PREPARATION THEREOF
US5378612A (en) 1990-05-11 1995-01-03 Juridical Foundation The Chemo-Sero-Therapeutic Research Institute Culture medium for production of recombinant protein
US5712086A (en) 1990-05-15 1998-01-27 New York Blood Center, Inc. Process for transfusing cell containing fractions sterilized with radiation and a quencher of type I and type II photodynamic reactions
US5232844A (en) 1990-05-15 1993-08-03 New York Blood Center Photodynamic inactivation of viruses in cell-containing compositions
FR2662166A1 (fr) 1990-05-18 1991-11-22 Fondation Nale Transfusion San Procede de preparation de facteur viii de tres haute purete comprenant une etape rapide d'immunoadsorption.
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
JP3127263B2 (ja) 1990-07-12 2001-01-22 バクスター、ダイアグノスティックス、インコーポレイテッド 第▲ＶＩＩＩ▼：Ｃａ因子色素原アッセイ
AU650045B2 (en) 1990-09-12 1994-06-09 Lifecell Corporation Method and apparatus for cryopreparation dry stabilization and rehydration of biological suspensions
US5272135A (en) 1991-03-01 1993-12-21 Chiron Ophthalmics, Inc. Method for the stabilization of methionine-containing polypeptides
FR2673632A1 (fr) 1991-03-08 1992-09-11 Lille Transfusion Sanguine Procede de preparation de concentre de facteur von willebrand humain de tres haute purete, approprie a un usage therapeutique.
DE4111393A1 (de) 1991-04-09 1992-10-15 Behringwerke Ag Stabilisierte faktor viii-praeparationen
SE468480B (sv) 1991-05-24 1993-01-25 Arne Holmgren Modifierat tioredoxin och dess anvaendning
WO1993000807A1 (en) 1991-07-03 1993-01-21 Cryolife, Inc. Method for stabilization of biomaterials
US5254350A (en) 1991-07-22 1993-10-19 Helena Laboratories Corporation Method of preparing a thromboplastin extract
CA2078721A1 (en) 1991-09-24 1993-03-25 Hiroshi Yonemura Process for preparing human coagulation factor viii protein complex
FR2681867B1 (fr) 1991-09-26 1993-12-31 Pasteur Merieux Serums Vaccins Procede de purification du facteur viii et preparations obtenues.
US5278289A (en) 1991-11-12 1994-01-11 Johnson Alan J Antihemophilic factor stabilization
US5192743A (en) 1992-01-16 1993-03-09 Genentech, Inc. Reconstitutable lyophilized protein formulation
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
AT399818B (de) 1992-04-24 1995-07-25 Immuno Ag Verfahren zur herstellung einer hochgereinigten virussicheren faktor viii-präparation
US5288853A (en) 1992-04-30 1994-02-22 Alpha Therapeutic Corporation Factor viii purification process
AU670793B2 (en) 1992-04-30 1996-08-01 Alpha Therapeutic Corporation Improved solubilization and stabilization of factor VIII complex
US5378601A (en) 1992-07-24 1995-01-03 Montefiore Medical Center Method of preserving platelets with apyrase and an antioxidant
US5424471A (en) * 1992-07-31 1995-06-13 U.S. Bioscience, Inc. Crystalline amifostine compositions and methods of the preparation and use of same
WO1994007510A1 (en) * 1992-10-02 1994-04-14 Kabi Pharmacia Ab Composition comprising coagulation factor viii formulation, process for its preparation and use of a surfactant as stabilizer
IT1256622B (it) 1992-12-04 1995-12-12 Sclavo Spa Processo per l'estrazione del complesso fattore viii-fattore von willebrand (fviii:c-fvw) da plasma umano totale.
DE4242863A1 (de) 1992-12-18 1994-06-23 Boehringer Mannheim Gmbh Stabile lyophilisierte pharmazeutische Zubereitungen von G-CSF
JPH08506498A (ja) 1993-02-09 1996-07-16 オクタファルマ・アクチエンゲセルシャフト 非脂質被覆ウイルスの失活方法
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
US5576291A (en) 1993-09-13 1996-11-19 Baxter International Inc. Activated factor VIII as a therapeutic agent and method of treating factor VIII deficiency
US5353835A (en) 1993-09-23 1994-10-11 Ingersoll-Rand Company Air tank drain
IT1268920B1 (it) 1994-03-29 1997-03-13 Syfal Srl Macchina rotativa per la decorazione-smaltatura in particolare dipiastrelle ceramiche.
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
US5955448A (en) 1994-08-19 1999-09-21 Quadrant Holdings Cambridge Limited Method for stabilization of biological substances during drying and subsequent storage and compositions thereof
FR2719479B1 (fr) * 1994-05-04 1996-07-26 Sanofi Elf Formulation stable lyophilisée comprenant une protéine: kit de dosage.
CN1188171C (zh) 1994-06-02 2005-02-09 廓德伦特控股剑桥有限公司 防止各种特质在再水化或熔化时聚集的方法以及由此获得的组合物
US5580856A (en) 1994-07-15 1996-12-03 Prestrelski; Steven J. Formulation of a reconstituted protein, and method and kit for the production thereof
DE4431833C1 (de) 1994-09-07 1995-05-18 Blutspendedienst Der Drk Lande Verfahren zur Herstellung eines AHF-Konzentrates
GB2293100A (en) 1994-09-15 1996-03-20 Medeva Europ Ltd Pharmaceutical compositions with deuterium oxide
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
AU4526996A (en) * 1994-12-28 1996-07-19 Biotime, Inc. Plasma expanders and blood substitutes
GB9501040D0 (en) * 1995-01-19 1995-03-08 Quadrant Holdings Cambridge Dried composition
SE9501189D0 (sv) * 1995-03-31 1995-03-31 Pharmacia Ab Protein formulation
US5679549A (en) 1995-05-04 1997-10-21 Bayer Corporation Production of recombinant factor VIII in the presence of liposome-like substances of mixed composition
JP3927248B2 (ja) * 1995-07-11 2007-06-06 第一製薬株式会社 Ｈｇｆ凍結乾燥製剤
KR0167677B1 (ko) * 1995-08-31 1999-02-01 김광호 다중 비트 테스트를 위한 패턴 발생기를 가지는 메모리 테스트 시스템
SE9503380D0 (sv) 1995-09-29 1995-09-29 Pharmacia Ab Protein derivatives
ES2099678B1 (es) 1995-11-03 1998-02-16 Grifols Grupo Sa Procedimiento para la inactivacion de virus en proteinas.
AU723016B2 (en) 1995-11-06 2000-08-17 New York Blood Center, Inc., The Viral inactivation treatment of red blood cells using phthalocyanines and red light
US5659017A (en) 1995-11-07 1997-08-19 Alpha Therapeutic Corporation Anion exchange process for the purification of Factor VIII
US5925738A (en) 1995-12-01 1999-07-20 The American National Red Cross Methods of production and use of liquid formulations of plasma proteins
US5851800A (en) 1996-05-14 1998-12-22 Pharmacia & Upjohn Ab Process for producing a protein
US6632648B1 (en) 1996-05-14 2003-10-14 Elan Drug Delivery Limited Methods of terminal sterilization of fibrinogen
US5763401A (en) * 1996-07-12 1998-06-09 Bayer Corporation Stabilized albumin-free recombinant factor VIII preparation having a low sugar content
JP5149470B2 (ja) * 1999-02-22 2013-02-20 バクスター・インターナショナル・インコーポレイテッド 新規のアルブミンを含有していない第ｖｉｉｉ因子処方物
DK1194161T3 (da) 1999-07-13 2006-02-13 Biovitrum Ab Stabile faktor VIII-sammensatninger
US6440414B1 (en) * 1999-10-01 2002-08-27 Amgen Inc. Pharmaceutical compositions of fibrinolytic agent
KR20150138427A (ko) 2003-12-19 2015-12-09 노보 노르디스크 헬스 케어 악티엔게젤샤프트 인자 ｖｉｉ 폴리펩티드의 안정화된 조성물
WO2007074880A1 (ja) 2005-12-28 2007-07-05 Chugai Seiyaku Kabushiki Kaisha 抗体含有安定化製剤
US9283260B2 (en) 2006-04-21 2016-03-15 Amgen Inc. Lyophilized therapeutic peptibody formulations
ES2382443T3 (es) 2008-09-03 2012-06-08 Octapharma Ag Composiciones estabilizadas para factor VIII producido de manera recombinante

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