CA2634664A1 - Novel albumin-free factor viii formulations - Google Patents

Novel albumin-free factor viii formulations Download PDF

Info

Publication number
CA2634664A1
CA2634664A1 CA002634664A CA2634664A CA2634664A1 CA 2634664 A1 CA2634664 A1 CA 2634664A1 CA 002634664 A CA002634664 A CA 002634664A CA 2634664 A CA2634664 A CA 2634664A CA 2634664 A1 CA2634664 A1 CA 2634664A1
Authority
CA
Canada
Prior art keywords
factor viii
group
nacl
agent selected
raffinose
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
Application number
CA002634664A
Other languages
French (fr)
Other versions
CA2634664C (en
Inventor
Marc Besman
Erik Bjornson
Feroz Jameel
Ramesh Kashi
Michael Pikal
Serguei Tchessalov
John Carpenter
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
University of Connecticut
Baxter International Inc
Original Assignee
University Of Connecticut
Marc Besman
Erik Bjornson
Feroz Jameel
Ramesh Kashi
Michael Pikal
Serguei Tchessalov
John Carpenter
Baxter International Inc.
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
Family has litigation
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=CA2634664(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by University Of Connecticut, Marc Besman, Erik Bjornson, Feroz Jameel, Ramesh Kashi, Michael Pikal, Serguei Tchessalov, John Carpenter, Baxter International Inc. filed Critical University Of Connecticut
Publication of CA2634664A1 publication Critical patent/CA2634664A1/en
Application granted granted Critical
Publication of CA2634664C publication Critical patent/CA2634664C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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
    • 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

Abstract

A Factor VIII composition formulated without albumin, comprising the following formulation excipients in addition to Factor VIII: 4% to 10% of a bulking agent selected from the group consisting of mannitol, glycine and alanine; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8. Alternatively, the formulation can comprise 2% to 6% hydroxyethyl starch; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8. In a further embodiment, the formulation can comprise: 300 mM to 500 mM NaCl; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; and a buffering agent.

Claims

CLAIMS:
1. An improved method of lyophilizing an aqueous pharmaceutical formulation containing a crystallisable bulking agent and NaCl, wherein said method comprises the steps of:
(a) freezing the aqueous pharmaceutical formulation at a temperature of less than about -35°C;
(b) annealing the pharmaceutical formulation at between about -30°C
and -19°C;
(c) lowering the temperature of the pharmaceutical formulation to less than about -50°C;
(d) annealing the pharmaceutical formulation at between about -30°C
and -39°C; and then (e) freeze-drying the pharmaceutical formulation.
CA2634664A 1999-02-22 2000-02-22 Novel albumin-free factor viii formulations Expired - Lifetime CA2634664C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US25527999A 1999-02-22 1999-02-22
US09/255,279 1999-02-22
US45275299A 1999-12-01 1999-12-01
US09/452,752 1999-12-01
CA2362927A CA2362927C (en) 1999-02-22 2000-02-22 Novel albumin-free factor viii formulations

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CA2362927A Division CA2362927C (en) 1999-02-22 2000-02-22 Novel albumin-free factor viii formulations

Publications (2)

Publication Number Publication Date
CA2634664A1 true CA2634664A1 (en) 2000-08-24
CA2634664C CA2634664C (en) 2011-08-09

Family

ID=26944588

Family Applications (4)

Application Number Title Priority Date Filing Date
CA002634663A Expired - Lifetime CA2634663C (en) 1999-02-22 2000-02-22 Novel albumin-free factor viii formulations
CA2634664A Expired - Lifetime CA2634664C (en) 1999-02-22 2000-02-22 Novel albumin-free factor viii formulations
CA002634674A Abandoned CA2634674A1 (en) 1999-02-22 2000-02-22 Novel albumin-free factor viii formulations
CA2362927A Expired - Lifetime CA2362927C (en) 1999-02-22 2000-02-22 Novel albumin-free factor viii formulations

Family Applications Before (1)

Application Number Title Priority Date Filing Date
CA002634663A Expired - Lifetime CA2634663C (en) 1999-02-22 2000-02-22 Novel albumin-free factor viii formulations

Family Applications After (2)

Application Number Title Priority Date Filing Date
CA002634674A Abandoned CA2634674A1 (en) 1999-02-22 2000-02-22 Novel albumin-free factor viii formulations
CA2362927A Expired - Lifetime CA2362927C (en) 1999-02-22 2000-02-22 Novel albumin-free factor viii formulations

Country Status (19)

Country Link
US (8) US6586573B1 (en)
EP (5) EP1820516B1 (en)
JP (9) JP5149470B2 (en)
CN (3) CN101810854A (en)
AT (1) ATE365052T1 (en)
AU (1) AU777972B2 (en)
BR (1) BR0008405B1 (en)
CA (4) CA2634663C (en)
CY (2) CY1108030T1 (en)
CZ (3) CZ307322B6 (en)
DE (1) DE60035260T2 (en)
DK (4) DK1154796T3 (en)
ES (4) ES2435141T3 (en)
HK (4) HK1139862A1 (en)
MX (1) MXPA01008515A (en)
PL (4) PL203177B1 (en)
PT (4) PT2193809E (en)
RU (1) RU2244556C2 (en)
WO (1) WO2000048635A1 (en)

Families Citing this family (126)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7244824B2 (en) * 1995-01-19 2007-07-17 Quadrant Drug Delivery Limited Dried blood factor composition comprising trehalose
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
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
PT2193809E (en) * 1999-02-22 2015-08-24 Baxter Int Albumin-free factor viii formulations
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 (en) 2001-12-21 2004-11-16 Novo Nordisk Healthcare Ag Liquid aqueous composition, method for preparing a liquid aqueous composition of a factor vii polypeptide, use of a liquid aqueous composition, and method for treating a factor vii response syndrome
KR20040065278A (en) * 2001-12-21 2004-07-21 노보 노르디스크 에이/에스 Liquid composition of modified factor vii polypeptides
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
KR101212025B1 (en) * 2002-06-21 2013-01-09 노보 노르디스크 헬스 케어 악티엔게젤샤프트 Stabilised solid compositions of factor ⅶ polypeptides
GB0304636D0 (en) * 2003-02-28 2003-04-02 Britannia Pharmaceuticals Ltd Pharmaceutical composition for nasal delivery
CA2518327A1 (en) * 2003-03-18 2004-09-30 Novo Nordisk Health Care Ag Liquid, aqueous, pharmaceutical compositions of factor vii polypeptides
US7897734B2 (en) * 2003-03-26 2011-03-01 Novo Nordisk Healthcare Ag Method for the production of proteins
AU2004241698A1 (en) * 2003-05-23 2004-12-02 Novo Nordisk Health Care Ag Protein stabilization in solution
ES2382157T3 (en) * 2003-06-25 2012-06-05 Novo Nordisk Health Care Ag Liquid composition of factor VII polypeptides
ATE446768T1 (en) * 2003-07-01 2009-11-15 Novo Nordisk Healthcare Ag LIQUID AQUEOUS PHARMACEUTICAL COMPOSITION OF FACTOR VII POLYPEPTIDES
DE10333317A1 (en) * 2003-07-22 2005-02-17 Biotecon Therapeutics Gmbh Formulation for protein medicines without the addition of human serum albumin (HSA)
CA2531988C (en) * 2003-08-05 2016-06-28 Novo Nordisk A/S Novel insulin derivatives
KR100560697B1 (en) * 2003-08-06 2006-03-16 씨제이 주식회사 Formulation of albumin-free erythropoietin
EP1656158B1 (en) 2003-08-14 2016-03-09 Novo Nordisk Health Care AG Liquid, aqueous pharmaceutical composition of factor vii polypeptides
US8541002B2 (en) * 2003-09-12 2013-09-24 Agenus Inc. Vaccine for treatment and prevention of herpes simplex virus infection
MXPA06006886A (en) * 2003-12-19 2006-09-04 Novo Nordisk Healthcare Ag Stabilised compositions of factor vii polypeptides.
GB0404586D0 (en) * 2004-03-01 2004-04-07 Britannia Pharmaceuticals Ltd Improvements in or relating to organic materials
WO2005089712A1 (en) * 2004-03-04 2005-09-29 Wyeth Lyophilization method to improve excipient crystallization
CA2557061C (en) * 2004-03-19 2013-08-20 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 (en) * 2004-06-25 2006-09-19 주식회사 녹십자홀딩스 Pharmaceutical preparation of recombinant factor ? lyophilized without albumin as a stabilizer
PT1835938E (en) * 2004-12-27 2013-11-06 Baxter Int Polymer-von willebrand factor-conjugates
FR2881139A1 (en) * 2005-01-26 2006-07-28 Agronomique Inst Nat Rech Liquid for lyophilization of proteins, useful for stabilizing pharmaceuticals or analytical proteins, comprises a filler, stabilizer, buffer and optionally nonionic surfactant
US7956160B2 (en) * 2005-07-22 2011-06-07 Amgen Inc. Concentrated protein lyophilates, methods, and uses
JP5555425B2 (en) 2005-11-01 2014-07-23 ワイス・エルエルシー Sodium chloride solution for drug reconstitution or dilution
EP2299271B9 (en) * 2005-11-09 2014-02-26 Ajinomoto Co., Inc. Kokumi-imparting compositions
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 (en) * 2005-11-22 2009-12-27 Вайет (Us) COMPOSITIONS CONTAINING HYBRID PROTEINS INCLUDING IMMUNOGLOBULIN
PT1969004E (en) 2005-12-28 2011-11-25 Novo Nordisk As Compositions comprising an acylated insulin and zinc and method of making the said compositions
EP2010222A1 (en) 2006-03-31 2009-01-07 Baxter International Inc. Pegylated factor viii
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
JP5094850B2 (en) * 2006-05-31 2012-12-12 ジェンザイム コーポレーション Use of polysaccharides to promote enzyme activity
CN103933612B (en) 2006-10-27 2016-06-22 爱德华兹生命科学公司 Biological tissue for Srgery grafting
AR063606A1 (en) * 2006-11-07 2009-02-04 Acambis Inc VACCINE STABILIZATION THROUGH LIOFILIZATION
JP5876208B2 (en) 2006-12-15 2016-03-02 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 Factor VIIa- (poly) sialic acid conjugate with extended in vivo half-life
FR2913020B1 (en) 2007-02-23 2012-11-23 Biomethodes NEW VIII FACTORS FOR THE TREATMENT OF TYPE A HEMOPHILS
WO2008107908A1 (en) * 2007-03-05 2008-09-12 Cadila Healthcare Limited Compositions comprising peg- interferon alpha conjugates and raffinose as cryoprotectant
AU2013204652B2 (en) * 2007-04-26 2015-06-18 Bayer Healthcare Llc Stabilization of liquid solutions of recombinant protein for frozen storage
RU2469739C2 (en) * 2007-04-26 2012-12-20 БАЙЕР ХЕЛСКЕА ЛЛСи Stabilisation of liquid solutions of recombinant protein for storing in frozen state
EP2156753A4 (en) * 2007-05-08 2010-11-24 Ajinomoto Kk Low-fat food
US9101691B2 (en) 2007-06-11 2015-08-11 Edwards Lifesciences Corporation Methods for pre-stressing and capping bioprosthetic tissue
US9034818B2 (en) * 2007-06-13 2015-05-19 Novo Nordisk A/S Pharmaceutical formulations 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 (en) * 2007-08-31 2011-11-30 上海医药工业研究院 Medicament composition containing defibrase modified by PEG
CA2991162A1 (en) * 2007-12-21 2009-07-02 Aptevo Biotherapeutics Llc Stabilized factor ix formulations containing trehalose
US8357387B2 (en) 2007-12-21 2013-01-22 Edwards Lifesciences Corporation Capping bioprosthetic tissue to reduce calcification
SG10201503304RA (en) * 2007-12-27 2015-06-29 Baxter Int Cell culture processes
EP2113564A1 (en) * 2008-05-01 2009-11-04 Arecor Limited Protein formulation
CA2729972C (en) * 2008-08-05 2018-11-20 Wyeth Llc Lyophilization above collapse
AU2009284113B2 (en) 2008-08-21 2015-05-14 Octapharma Ag Recombinantly produced human factor VIII and IX
MX2011002159A (en) * 2008-08-27 2011-03-29 Schering Corp Lyophilized formulatons of engineered anti-il-23p19 antibodies.
EP2337580B1 (en) * 2008-09-03 2012-03-28 Octapharma AG Stabilized compositions for recombinantly produced factor viii
US20100068210A1 (en) * 2008-09-10 2010-03-18 Ji Junyan A Compositions and methods for the prevention of oxidative degradation of proteins
AU2009309623B9 (en) * 2008-10-30 2014-10-02 Novo Nordisk A/S Treating diabetes melitus using insulin injections with less than daily injection frequency
BRPI0921429B1 (en) 2008-11-07 2022-07-12 Takeda Pharmaceutical Company Limited STABLE LYOPHILIZED PHARMACEUTICAL FORMULATION, AND METHOD FOR PREPARING A STABLE LYOPHILIZED FACTOR
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
EP3081233B1 (en) 2009-07-27 2020-12-23 Baxalta GmbH Glycopolysialylation of proteins other than blood coagulation proteins
US8642737B2 (en) 2010-07-26 2014-02-04 Baxter International Inc. Nucleophilic catalysts for oxime linkage
DK2459224T3 (en) 2009-07-27 2016-07-25 Baxalta GmbH Blodstørkningsproteinkonjugater
ES2856055T3 (en) 2009-07-27 2021-09-27 Baxalta GmbH Glycopolysialylation of proteins other than blood clotting proteins
GB0915480D0 (en) 2009-09-04 2009-10-07 Arecor Ltd Stable formulation of factor viii
ES2865250T3 (en) 2009-09-21 2021-10-15 Takeda Pharmaceuticals Co Stabilized Liquid and Freeze-Dried ADAMTS13 Formulations
EP2496246B1 (en) 2009-11-03 2018-06-27 Grifols Therapeutics LLC Composition, method, and kit for alpha-1 proteinase inhibitor
HUE037733T2 (en) * 2009-11-24 2018-09-28 Grifols Therapeutics Inc Lyophilization methods, compositions, and kits
RU2012135505A (en) * 2010-01-19 2014-02-27 Ханми Сайенс Ко., Лтд. LIQUID COMPOSITIONS FOR LONG-TERM ETHYTROPOETIN CONJUGATE
EP2549957B1 (en) 2010-03-23 2019-01-30 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
TW201213342A (en) * 2010-09-17 2012-04-01 Baxter Int Stabilization of immunoglobulins and other proteins through aqueous formulation with sodium chloride at weak acidic to neutral pH
US9173944B2 (en) 2010-10-12 2015-11-03 Merz Pharma Gmbh & Co. Kgaa Formulation suitable for stabilizing proteins, which is free of mammalian excipients
JP6049625B2 (en) 2010-10-27 2016-12-21 ノヴォ ノルディスク アー／エス Treatment of diabetes mellitus using insulin injections given at various injection intervals
EA035447B1 (en) 2010-11-05 2020-06-17 Баксалта Инкорпорейтид Isolated recombinant partially b-domain deleted factor viii (fviii) variant
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
PL2654794T3 (en) 2010-12-22 2020-07-27 Baxalta GmbH Materials and methods for conjugating a water soluble fatty acid derivative to a protein
BRPI1105317A2 (en) 2011-01-24 2013-04-30 Fundacco Hemoct De Ribeirco Preto stable and large-scale production of human fviii in human cell line sk-hep-1
KR102289394B1 (en) 2011-03-31 2021-08-13 머크 샤프 앤드 돔 코포레이션 Stable formulations of antibodies to human programmed death receptor pd-1 and related treatments
JP6060447B2 (en) 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 Sso7 polymerase conjugate with reduced non-specific activity
CN103703141B (en) 2011-04-08 2016-08-17 伯乐实验室公司 There is the PCR reactant mixture of the nonspecific activity of reduction
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
CN105209487A (en) * 2013-03-15 2015-12-30 拜耳医药保健有限公司 Recombinant Factor VIII formulations
CA2899737A1 (en) * 2013-03-15 2014-09-18 Biogen Ma Inc. Factor viii polypeptide formulations
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 (en) * 2013-12-16 2019-12-24 주식회사 티움바이오 Pharmaceutical composition having improved stability comprising a fusion protein of factor vii
MX2016012870A (en) * 2014-04-01 2017-05-12 Advantech Bioscience Farmacêutica Ltda Stable factor viii formulations with low sugar-glycine.
US9855319B2 (en) 2014-04-01 2018-01-02 Advantech Bioscience Farmacêutica Ltda Stabilization of factor VIII without calcium as an excipient
AU2015299224B2 (en) * 2014-08-04 2019-06-20 Csl Limited Factor VIII formulation
CA2961739A1 (en) * 2014-08-20 2016-02-25 Portola Pharmaceuticals, Inc. Lyophilized formulations for factor xa antidote
CN114129709A (en) * 2014-10-23 2022-03-04 恩格姆生物制药公司 Pharmaceutical compositions comprising peptide variants and methods of use thereof
DK3287140T3 (en) 2015-04-21 2021-07-19 Beijing Staidson Medical Tech Co Ltd Nerve growth factor composition and powder injection
US10576129B2 (en) 2015-04-21 2020-03-03 Staidson (Beijing) Biopharmaceuticals Co., Ltd. Nerve growth factor composition and powder injection
US20170007694A1 (en) * 2015-07-07 2017-01-12 Nanobio Corporation Methods and compositions for the stabilization of proteins
GB2556002B (en) 2015-07-07 2020-12-16 Bluewillow Biologics Inc Methods and compositions for nanoemulsion vaccine formulations
WO2017011275A1 (en) * 2015-07-10 2017-01-19 Nersissian Aram M Factor viii protein compositions and methods of treating hemophilia a
EP3167877A1 (en) * 2015-11-12 2017-05-17 Bayer Pharma Aktiengesellschaft Method for the production of freeze-dried pellets comprising factor viii
US20190046450A1 (en) * 2016-02-24 2019-02-14 Portola Pharmaceuticals, Inc. Lyophilized formulations for factor xa antidote
CN109640961B (en) * 2016-06-01 2021-11-02 施维雅知识产权英国有限公司 Polyalkylene oxide-asparaginase formulations and methods of making and using same
CN110381962B (en) * 2016-12-21 2023-10-13 孙崇谨 Novel method for the active preservation of plasma proteins
JOP20190260A1 (en) 2017-05-02 2019-10-31 Merck Sharp & Dohme Stable formulations of programmed death receptor 1 (pd-1) antibodies and methods of use thereof
SG11201909955XA (en) 2017-05-02 2019-11-28 Merck Sharp & Dohme Formulations of anti-lag3 antibodies and co-formulations of anti-lag3 antibodies and anti-pd-1 antibodies
JP6630315B2 (en) 2017-06-27 2020-01-15 矢崎総業株式会社 Noise reduction unit
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
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
CN110772487B (en) * 2019-12-09 2021-09-21 湖南科伦制药有限公司 Freeze-drying method of ethylenediamine diaceturate
CN112121009B (en) * 2020-09-24 2022-12-02 科兴生物制药股份有限公司 New preparation of polyethylene glycol modified recombinant human granulocyte stimulating factor
EP4217394A1 (en) 2020-09-24 2023-08-02 Merck Sharp & Dohme LLC Stable formulations of programmed death receptor 1 (pd-1) antibodies and hyaluronidase variants and fragments thereof and methods of use thereof
EP4240757A2 (en) 2020-11-09 2023-09-13 Takeda Pharmaceutical Company Limited Purification of fviii from plasma using silicon oxide adsorption
WO2022217041A1 (en) * 2021-04-09 2022-10-13 Hyalo Technologies, LLC Method of sterilization of biologics
AU2022326188A1 (en) * 2021-08-11 2024-02-22 Grifols Worldwide Operations Limited Method for producing human plasma-derived factor viii / von willebrand factor and composition obtained
CN114015758B (en) * 2021-10-15 2022-06-24 无锡百泰克生物技术有限公司 Freeze-drying protective agent, fluorescent PCR detection kit and freeze-drying process

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
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
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
US4189425A (en) 1975-04-11 1980-02-19 Edward Shanbrom, Inc. Method of preserving blood plasma I
US4086218A (en) 1975-04-11 1978-04-25 Edward Shanbrom, Inc. Method of preserving blood plasma II
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 (en) 1976-12-30 1979-05-25 Московский Ордена Ленина И Ордена Трудового Красного Знамени Государственный Университет Им. М.В.Ломоносова Method of obtaining fibrin monomer
US4137223A (en) 1977-05-16 1979-01-30 Edward Shanbrom, Inc. Method of preserving blood plasma II
SE443293B (en) 1978-01-25 1986-02-24 Blombaeck E G B Blood fraction FRONT TELL NING
DE2916711A1 (en) 1979-04-25 1980-11-06 Behringwerke Ag Blood coagulation factors and process for their manufacture
US4783441A (en) 1979-04-30 1988-11-08 Hoechst Aktiengesellschaft Aqueous protein solutions stable to denaturation
FR2460305A2 (en) 1979-06-29 1981-01-23 Merieux Inst PROCESS FOR PREPARING A FACTOR VIII CONCENTRATE
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
DE3176491D1 (en) 1980-03-05 1987-11-26 Miles Lab 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 (en) 1980-08-27 1982-12-27 Immuno Ag METHOD FOR PRODUCING A FACTOR VIII (AHF) HIGH CONCENTRATE
DE3033932C2 (en) 1980-09-10 1984-05-24 Biotest-Serum-Institut Gmbh, 6000 Frankfurt Process for the cold sterilization of preparations containing blood coagulation factor VIII
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
US4382083A (en) 1981-06-25 1983-05-03 Baxter Travenol Laboratories, Inc. Therapeutic method for treating blood-clotting defects with factor VIIa
US4479938A (en) 1981-06-25 1984-10-30 Baxter Travenol Laboratories, Inc. Therapeutic composition containing factor VIIa
JPS5874617A (en) 1981-10-28 1983-05-06 Green Cross Corp:The Heat-treating method of aqueous solution containing blood coagulation factor 8 derived from human
US4456590B2 (en) 1981-11-02 1989-05-30 Heat treatment of lyphilized blood clotting factor viii concentrate
US4481189A (en) 1982-04-14 1984-11-06 New York Blood Center Inc. Process for preparing sterilized plasma and plasma derivatives
US4591505A (en) 1982-04-14 1986-05-27 New York Blood Center, Inc. Process for inactivating hepatitis B virus
US4495175A (en) 1982-08-05 1985-01-22 University Of Rochester Preparation of highly purified human antihemophilic factor
DE3230849A1 (en) 1982-08-19 1984-02-23 Behringwerke Ag, 3550 Marburg PASTEURIZED HUMAN FIBRINOGEN (HF) AND METHOD FOR THE PRODUCTION THEREOF
DE3237512A1 (en) 1982-10-09 1984-04-12 Behringwerke Ag, 3550 Marburg METHOD FOR PASTEURIZING ANTIHAEMOPHILIC CRYOPRAEZIPITATE (AHK) AND ANTIHAEMOPHILE CRYOPRAECIPITATE PRODUCED THEREOF
GB2129685B (en) 1982-11-11 1985-11-13 Nat Biolog Standards Board Anti-haemophilic compositions
JPS59134730A (en) 1983-01-20 1984-08-02 Green Cross Corp:The Heat treatment of viii factor of blood clotting
ZA842418B (en) 1983-03-31 1984-11-28 Scripps Clinic Res Factor viii coagulant polypeptides and monoclonal antibodies to them
US4748120A (en) 1983-05-02 1988-05-31 Diamond Scientific Co. Photochemical decontamination treatment of whole blood or blood components
US4727027A (en) 1983-05-02 1988-02-23 Diamond Scientific Co. Photochemical decontamination treatment of whole blood or blood components
DE3481109D1 (en) 1983-05-09 1990-03-01 Novo Nordisk As ANTIHAEMOPHILIA FACTOR VIII CONCENTRATE AND THEIR PRODUCTION METHOD.
AT379510B (en) 1983-05-20 1986-01-27 Immuno Ag METHOD FOR PRODUCING A FACTOR VIII (AHF) CONTAINING PRAEPARATION
DE3318521A1 (en) 1983-05-20 1984-11-22 Lentia GmbH Chem. u. pharm. Erzeugnisse - Industriebedarf, 8000 München METHOD FOR PRODUCING AN ANTIHAEMOPHILIE FACTOR CONCENTRATE
US4540573A (en) 1983-07-14 1985-09-10 New York Blood Center, Inc. Undenatured virus-free biologically active protein derivatives
DE3336631A1 (en) 1983-10-08 1985-04-18 Behringwerke Ag, 3550 Marburg METHOD FOR THE PASTEURIZATION OF PLASMA OR CONCENTRATES OF THE BLOOD COAGINING FACTORS II, VII, IX AND 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 (en) 1983-12-28 1986-01-30 Green Cross Corp:The Method for heat-treating blood plasma protein
DE10399009I1 (en) 1984-01-12 2003-10-23 Chiron Corp DNA sequences encoding factor VIIIc and related DNA constructions
AT389815B (en) 1984-03-09 1990-02-12 Immuno Ag METHOD FOR INACTIVATING VARIABLE FILTERABLE DISEASERS IN BLOOD PRODUCTS
US4831012A (en) 1984-03-23 1989-05-16 Baxter International Inc. Purified hemoglobin solutions and method for making same
JPS60199829A (en) 1984-03-24 1985-10-09 Nippon Sekijiyuujishiya Preparation of high-purity antihemophilic globulin
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 (en) * 1985-05-24 1986-12-01 Dainippon Pharmaceut Co Ltd Human interleukine 1 polypeptide and derivative thereof
US4952675A (en) 1985-02-01 1990-08-28 New York University Method for purifying antihemophilic factor
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
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 (en) 1985-08-05 1990-05-23 IMMUNO Aktiengesellschaft für chemisch-medizinische Produkte Process for producing preparations based on blood coagulation factors
AU6487286A (en) 1985-11-08 1987-05-14 Baxter Travenol Laboratories Inc. Antihemophilic factor by cold precipitation
US5180583A (en) 1985-11-26 1993-01-19 Hedner Ulla K E Method for the treatment of bleeding disorders
JPS62195331A (en) 1986-02-24 1987-08-28 Nippon Sekijiyuujishiya Production of blood coagulation factor viii pharmaceutical
AT390374B (en) 1986-03-18 1990-04-25 Schwab & Co Gmbh METHOD FOR PASTEURIZING PLASMA PROTEIN AND PLASMA PROTEIN FRACTIONS
DE3609431A1 (en) 1986-03-20 1987-09-24 Biotest Pharma Gmbh METHOD FOR PRODUCING A STERILE PRESERVATIVE CONTAINING THE BLOOD coagulation factor VIII
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 (en) 1986-11-03 1990-12-10 Immuno Ag METHOD FOR PRODUCING A FACTOR VIII (AHF) CONTAINING FRACTION
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 (en) 1987-04-21 1989-05-01 Green Cross Corp Process for heat treating fibrinogen
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 (en) 1987-09-10 1991-04-11 Teijin Ltd Preparation of human active natural type factor viii c and transformant using the same
DE3730533A1 (en) 1987-09-11 1989-03-30 Biotest Pharma Gmbh METHOD FOR STERILIZING PLASMA OR PLASMA FACTIONS
KR890004724A (en) * 1987-09-17 1989-05-09 히사시 미하라 New protease preparations
CA1329760C (en) 1987-10-29 1994-05-24 Ted C. K. Lee Plasma and recombinant protein formulations in high ionic strength media
US5605884A (en) 1987-10-29 1997-02-25 Rhone-Poulenc Rorer Pharmaceuticals Inc. Factor VIII 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 (en) 1988-01-15 1988-01-15 Nordisk Gentofte PROCEDURE FOR PASTEURIZATION OF Aqueous SOLUTIONS OF FACTOR 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 (en) 1988-06-07 1990-08-24 Lille Transfusion Sanguine PROCESS FOR THE CHROMATOGRAPHIC PURIFICATION OF PROTEINS, PARTICULARLY FACTOR VIII, AND THE PRODUCTS OBTAINED
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 (en) * 1988-12-07 1990-06-18 Bio Kagaku Kenkyusho:Kk Cytostatic agent
DE3904354A1 (en) 1989-02-14 1990-08-16 Behringwerke Ag PASTEURIZED, PURIFIED OF WILLEBRAND FACTOR CONCENTRATE AND METHOD FOR THE PRODUCTION THEREOF
FR2665449B1 (en) 1990-08-02 1995-04-14 Aquitaine Developp Transf Sang METHOD FOR MANUFACTURING A VON WILLEBRAND FACTOR HAVING VERY HIGH PURITY, MAINLY LACKING AN ANTIHEMOPHILIC FACTOR (FVIIIC), AND VON WILLEBRAND FACTOR THUS OBTAINED, AS WELL AS A PHARMACEUTICAL COMPOSITION CONTAINING THE SAME.
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
CN1047342A (en) 1989-05-13 1990-11-28 杭州市中心血站 The production of Factor IX and virus inactivating method thereof
DK0399321T3 (en) 1989-05-24 1993-08-09 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
DK0410207T3 (en) 1989-07-24 1997-07-14 Bayer Ag Stabilization of Highly Purified Proteins.
DE3926034C3 (en) 1989-08-07 1996-11-21 Behringwerke Ag Process for the preparation of a stable factor VIII
FR2651437A1 (en) 1989-09-05 1991-03-08 Lille Transfusion Sanguine PROCESS FOR PREPARING A CONCENTRATE OF THE VON WILLEBRAND FACTOR VIII-FACTOR COMPLEX OF BLOOD COAGULATION FROM TOTAL PLASMA.
DK162233C (en) 1989-11-09 1992-03-16 Novo Nordisk As PROCEDURE FOR INSULATING FACTOR VIII FROM BLOOD PLASMA AND PHARMACEUTICAL PREPARATION CONTAINING THE ASSOCIATED PHATAR VIII
SE465222C5 (en) 1989-12-15 1998-02-10 Pharmacia & Upjohn Ab A recombinant human factor VIII derivative and process for its preparation
US5439882A (en) 1989-12-29 1995-08-08 Texas Tech University Health Sciences Center Blood substitute
DE4001451A1 (en) 1990-01-19 1991-08-01 Octapharma Ag STABLE INJECTABLE SOLUTIONS OF FACTOR VIII AND FACTOR 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 (en) 1990-05-18 1991-11-22 Fondation Nale Transfusion San PROCESS FOR PREPARING HIGHLY HIGH PURITY FACTOR VIII COMPRISING A RAPID IMMUNOADSORPTION STEP
IT1248723B (en) 1990-06-12 1995-01-26 Scalvo S P A PROCESS FOR THE PURIFICATION OF FACTOR VIII AND FACTOR VIII OBTAINED WITH SUCH PROCESS
JP3127263B2 (en) 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 Part VIII: Ca factor chromogen assay
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 (en) 1991-03-08 1992-09-11 Lille Transfusion Sanguine PROCESS FOR THE PREPARATION OF HUMAN VON WILLEBRAND FACTOR CONCENTRATE OF HIGH PURITY, SUITABLE FOR THERAPEUTIC USE
DE4111393A1 (en) 1991-04-09 1992-10-15 Behringwerke Ag STABILIZED FACTOR VIII PREPARATIONS
SE468480B (en) 1991-05-24 1993-01-25 Arne Holmgren Modified thioredoxin and its use
AU2309692A (en) 1991-07-03 1993-02-11 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 (en) 1991-09-26 1993-12-31 Pasteur Merieux Serums Vaccins FACTOR VIII PURIFICATION PROCESS AND PREPARATIONS OBTAINED.
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 (en) * 1992-01-17 1993-12-14 Asahi Chem Ind Co Ltd Lyophilized composition of calcitonin gene-related peptide and stabilization thereof
AT399818B (en) 1992-04-24 1995-07-25 Immuno Ag METHOD FOR PRODUCING A HIGH PURIFIED VIRUS-SAFE FACTOR VIII PREPARATION
EP0638091B1 (en) 1992-04-30 2005-12-07 Probitas Pharma Inc. Improved solubilization and stabilization of factor viii complex
US5288853A (en) 1992-04-30 1994-02-22 Alpha Therapeutic Corporation Factor viii purification process
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
EP1652534A3 (en) * 1992-10-02 2007-05-02 Genetics Institute, LLC Composition comprising coagulation factor VIII formulation, process for its preparation and use of a surfactant as stabilizer
IT1256622B (en) 1992-12-04 1995-12-12 Sclavo Spa PROCESS FOR THE EXTRACTION OF THE FACTOR VIII-FACTOR VON WILLEBRAND (FVIII: C-FVW) FROM TOTAL HUMAN PLASMA.
DE4242863A1 (en) * 1992-12-18 1994-06-23 Boehringer Mannheim Gmbh Stable lyophilized pharmaceutical preparations of G-CSF
WO1994017834A1 (en) 1993-02-09 1994-08-18 Octapharma Ag Method for inactivating viruses devoid of lipid envelopes
SE9301581D0 (en) * 1993-05-07 1993-05-07 Kabi Pharmacia Ab PROTEIN FORMULATION
SE504074C2 (en) 1993-07-05 1996-11-04 Pharmacia Ab Protein preparation for subcutaneous, intramuscular or intradermal administration
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 (en) 1994-03-29 1997-03-13 Syfal Srl ROTARY MACHINE FOR DECORATION-GLAZING IN PARTICULAR CERAMIC TILES.
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 (en) * 1994-05-04 1996-07-26 Sanofi Elf Stable lyophilized formulation comprising a protein: assay kit.
DE69530196T2 (en) 1994-06-02 2003-11-20 Elan Drug Delivery Ltd METHOD FOR PREVENTING THE AGGREGATION OF PROTEINS / PEPTIDES IN REHYDRATION OR THAWING
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 (en) 1994-09-07 1995-05-18 Blutspendedienst Der Drk Lande Prepn. of an anti-haemophilic factor from a cryo-precipitate
GB2293100A (en) 1994-09-15 1996-03-20 Medeva Europ Ltd Pharmaceutical compositions with deuterium oxide
SE9403915D0 (en) 1994-11-14 1994-11-14 Annelie Almstedt Process A
SE503424C2 (en) 1994-11-14 1996-06-10 Pharmacia Ab Process for purification of recombinant coagulation factor VIII
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 (en) * 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 (en) * 1995-07-11 2007-06-06 第一製薬株式会社 HGF lyophilized formulation
KR0167677B1 (en) * 1995-08-31 1999-02-01 김광호 Memory test system with pattern generator for multi-bit test
SE9503380D0 (en) 1995-09-29 1995-09-29 Pharmacia Ab Protein derivatives
ES2099678B1 (en) 1995-11-03 1998-02-16 Grifols Grupo Sa PROCEDURE FOR THE INACTIVATION OF VIRUSES IN PROTEINS.
ATE235814T1 (en) 1995-11-06 2003-04-15 New York Blood Ct Inc TREATMENT OF RED BLOOD CELLS TO INACTIVATE VIRIA BY USING PATHALOCYANINS 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
PT2193809E (en) * 1999-02-22 2015-08-24 Baxter Int Albumin-free factor viii formulations
JP4674021B2 (en) 1999-07-13 2011-04-20 ビオヴィトルム・アクチボラゲット（プブリクト） Stable factor VIII composition
US6440414B1 (en) * 1999-10-01 2002-08-27 Amgen Inc. Pharmaceutical compositions of fibrinolytic agent
MXPA06006886A (en) 2003-12-19 2006-09-04 Novo Nordisk Healthcare Ag Stabilised compositions of factor vii polypeptides.
EP1977763A4 (en) 2005-12-28 2010-06-02 Chugai Pharmaceutical Co Ltd Antibody-containing stabilizing preparation
JO3324B1 (en) 2006-04-21 2019-03-13 Amgen Inc Lyophilized Therapeutic Peptibody Formulations
EP2337580B1 (en) 2008-09-03 2012-03-28 Octapharma AG Stabilized compositions for recombinantly produced factor viii

Also Published As

Publication number Publication date
DK1154796T3 (en) 2007-09-24
CZ307715B6 (en) 2019-03-06
EP2921180B1 (en) 2019-08-14
CA2634664C (en) 2011-08-09
BR0008405A (en) 2002-04-30
CN100553678C (en) 2009-10-28
JP2008201801A (en) 2008-09-04
PT2130554E (en) 2012-11-19
CA2362927C (en) 2011-07-12
JP5006832B2 (en) 2012-08-22
US20080176791A1 (en) 2008-07-24
US9669076B2 (en) 2017-06-06
JP2003520764A (en) 2003-07-08
PL356453A1 (en) 2004-06-28
ES2541470T3 (en) 2015-07-20
US7247707B2 (en) 2007-07-24
US20170000854A1 (en) 2017-01-05
CN101683522A (en) 2010-03-31
JP5140539B2 (en) 2013-02-06
US20060205661A1 (en) 2006-09-14
PT2193809E (en) 2015-08-24
US20120083446A1 (en) 2012-04-05
CZ307715A3 (en) 2002-03-13
BR0008405B1 (en) 2014-04-22
EP1154796B1 (en) 2007-06-20
HK1139862A1 (en) 2010-09-30
CY1113969T1 (en) 2016-07-27
EP1820516A2 (en) 2007-08-22
DK2130554T3 (en) 2012-12-03
AU777972B2 (en) 2004-11-04
DK2193809T3 (en) 2015-05-26
CZ20012996A3 (en) 2002-03-13
DK1820516T3 (en) 2013-10-28
PL203893B1 (en) 2009-11-30
RU2244556C2 (en) 2005-01-20
WO2000048635A1 (en) 2000-08-24
PT1820516E (en) 2013-10-31
PL203177B1 (en) 2009-09-30
PT1154796E (en) 2007-09-28
JP2016040310A (en) 2016-03-24
CZ300547B6 (en) 2009-06-10
JP2012072198A (en) 2012-04-12
HK1213801A1 (en) 2016-07-15
CA2362927A1 (en) 2000-08-24
JP6155442B2 (en) 2017-07-05
ES2288843T3 (en) 2008-02-01
US20040116345A1 (en) 2004-06-17
MXPA01008515A (en) 2003-06-06
EP2193809B1 (en) 2015-04-08
DE60035260T2 (en) 2007-10-18
CY1108030T1 (en) 2013-09-04
US9352027B2 (en) 2016-05-31
US7087723B2 (en) 2006-08-08
CA2634663C (en) 2009-08-25
JP6253627B2 (en) 2017-12-27
US20130184216A1 (en) 2013-07-18
DE60035260D1 (en) 2007-08-02
EP2921180A1 (en) 2015-09-23
JP2009046499A (en) 2009-03-05
HK1106705A1 (en) 2008-03-20
JP2017125076A (en) 2017-07-20
US8372800B2 (en) 2013-02-12
EP2130554A1 (en) 2009-12-09
JP6038003B2 (en) 2016-12-07
ES2435141T3 (en) 2013-12-18
JP5149470B2 (en) 2013-02-20
EP1820516A3 (en) 2009-10-07
CA2634674A1 (en) 2000-08-24
JP2014024864A (en) 2014-02-06
US6586573B1 (en) 2003-07-01
EP1154796A1 (en) 2001-11-21
ES2394755T3 (en) 2013-02-05
CA2634663A1 (en) 2000-08-24
CN101683522B (en) 2013-05-01
US8058226B2 (en) 2011-11-15
US8765665B2 (en) 2014-07-01
HK1133583A1 (en) 2010-04-01
JP2018172413A (en) 2018-11-08
PL204701B1 (en) 2010-02-26
CN101810854A (en) 2010-08-25
JP2015091902A (en) 2015-05-14
EP2130554B1 (en) 2012-09-05
PL198123B1 (en) 2008-05-30
CZ307322B6 (en) 2018-06-06
EP2193809A1 (en) 2010-06-09
CN1399560A (en) 2003-02-26
JP5596064B2 (en) 2014-09-24
EP1820516B1 (en) 2013-07-24
US20150025010A1 (en) 2015-01-22
AU2884300A (en) 2000-09-04
ATE365052T1 (en) 2007-07-15

Similar Documents

Publication Publication Date Title
CA2634664A1 (en) Novel albumin-free factor viii formulations
RU2001125929A (en) NEW Albumin-Free Formulations of Factor VIII
JP2002522468A5 (en)
AU5103200A (en) Freeze dried hgf preparations
CA2001552C (en) Cyclophosphamide - sodium bicarbonate lyophilizates
US5268368A (en) Cyclophosphamide--amino acid lyophilizates

Legal Events

Date Code Title Description
EEER Examination request
MKEX Expiry

Effective date: 20200224