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MX2009011367A - Estabilizacion de soluciones liquidas de proteina recombinante para el almacenamiento congelado. - Google Patents

Estabilizacion de soluciones liquidas de proteina recombinante para el almacenamiento congelado.

Info

Publication number
MX2009011367A
MX2009011367A MX2009011367A MX2009011367A MX2009011367A MX 2009011367 A MX2009011367 A MX 2009011367A MX 2009011367 A MX2009011367 A MX 2009011367A MX 2009011367 A MX2009011367 A MX 2009011367A MX 2009011367 A MX2009011367 A MX 2009011367A
Authority
MX
Mexico
Prior art keywords
recombinant protein
frozen storage
stabilization
liquid solutions
solution
Prior art date
Application number
MX2009011367A
Other languages
English (en)
Inventor
Deqian Wang
Nelly Tsvetkova
Omkar Joshi
Paul Wu
Arnaud Desponds
Original Assignee
Bayer Healthcare Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bayer Healthcare Llc filed Critical Bayer Healthcare Llc
Publication of MX2009011367A publication Critical patent/MX2009011367A/es

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
    • 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
    • A61K47/26—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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Hematology (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Abstract

La invención se refiere a un método para estabilizar una solución a granel de proteína recombinante para el almacenamiento congelado, que comprende la provisión de una solución parcialmente purificada de la proteína recombinante que tiene una concentración de sal monovalente de al menos 100 mM, y la adición de un carbohidrato a dicha solución en una cantidad suficiente de modo que, después del congelamiento, la solución tiene una temperatura de transición vítrea de -56ºC o mayor.
MX2009011367A 2007-04-26 2008-04-22 Estabilizacion de soluciones liquidas de proteina recombinante para el almacenamiento congelado. MX2009011367A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US92669807P 2007-04-26 2007-04-26
PCT/US2008/061147 WO2008134310A1 (en) 2007-04-26 2008-04-22 Stabilization of liquid solutions of recombinant protein for frozen storage

Publications (1)

Publication Number Publication Date
MX2009011367A true MX2009011367A (es) 2010-03-22

Family

ID=39926041

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2009011367A MX2009011367A (es) 2007-04-26 2008-04-22 Estabilizacion de soluciones liquidas de proteina recombinante para el almacenamiento congelado.

Country Status (15)

Country Link
US (2) US8187799B2 (es)
EP (1) EP2150264A4 (es)
JP (1) JP5401446B2 (es)
KR (2) KR20150103333A (es)
CN (2) CN103990116A (es)
AU (1) AU2008245821B2 (es)
BR (1) BRPI0810500A2 (es)
CA (1) CA2683317C (es)
EC (1) ECSP099704A (es)
HK (1) HK1198815A1 (es)
IL (1) IL201508A0 (es)
MX (1) MX2009011367A (es)
RU (1) RU2469739C2 (es)
WO (1) WO2008134310A1 (es)
ZA (1) ZA200907247B (es)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same
US11197916B2 (en) 2007-12-28 2021-12-14 Takeda Pharmaceutical Company Limited Lyophilized recombinant VWF formulations
SG10201608059VA (en) * 2007-12-28 2016-11-29 Baxter Int Recombinant vwf formulations
TWI508735B (zh) * 2008-10-21 2015-11-21 巴克斯特國際公司 凍乾的重組ｖｗｆ調配物
EP2427211A4 (en) * 2009-05-04 2013-05-01 Abbott Biotech Ltd STABLE FORMULATIONS WITH HIGH PROTEIN CONCENTRATION OF ANTI-TNF-ALPHA HUMAN ANTIBODIES
NZ609469A (en) 2010-11-11 2015-02-27 Abbvie Biotechnology Ltd Improved high concentration anti-tnfα antibody liquid formulations
CN106414491B (zh) 2014-01-20 2021-06-18 奥克塔法马股份有限公司 一种制备FVIII:C/FVIII:Ag比例提高的因子VIII的方法
WO2015190098A1 (ja) 2014-06-13 2015-12-17 凸版印刷株式会社 針状体の製造方法及び針状体

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US4457916A (en) * 1982-08-31 1984-07-03 Asahi Kasei Kogyo Kabushiki Kaisha Method for stabilizing Tumor Necrosis Factor and a stable aqueous solution or powder containing the same
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
US5576194A (en) 1986-07-11 1996-11-19 Bayer Corporation Recombinant protein production
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
DE4111393A1 (de) * 1991-04-09 1992-10-15 Behringwerke Ag Stabilisierte faktor viii-praeparationen
US5278289A (en) * 1991-11-12 1994-01-11 Johnson Alan J Antihemophilic factor stabilization
CA2124690C (en) * 1992-10-02 2007-09-11 Thomas Osterberg Composition comprising coagulation factor viii formulation, process for its preparation and use of a surfactant as stabilizer
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
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
US6818439B1 (en) * 1994-12-30 2004-11-16 Chiron Corporation Methods for administration of recombinant gene delivery vehicles for treatment of hemophilia and other disorders
US6790439B1 (en) * 1995-06-07 2004-09-14 Zymogenetics, Inc. Thrombopoietin compositions
SE9503380D0 (sv) * 1995-09-29 1995-09-29 Pharmacia Ab Protein derivatives
US5770700A (en) 1996-01-25 1998-06-23 Genetics Institute, Inc. Liquid factor IX formulations
US5763401A (en) * 1996-07-12 1998-06-09 Bayer Corporation Stabilized albumin-free recombinant factor VIII preparation having a low sugar content
US5804420A (en) 1997-04-18 1998-09-08 Bayer Corporation Preparation of recombinant Factor VIII in a protein free medium
AT407255B (de) * 1997-06-20 2001-02-26 Immuno Ag Rekombinanter zellklon mit erhöhter stabilität in serum- und proteinfreiem medium und verfahren zur gewinnung des stabilen zellklons
ES2288843T3 (es) 1999-02-22 2008-02-01 University Of Connecticut Nuevas formulaciones de factor viii libres de albumina.
PL360914A1 (en) * 1999-07-15 2004-09-20 Genetics Institute Inc. Formulations for il-11
WO2003015805A1 (en) 2001-08-13 2003-02-27 Michael Hargreaves Riley Composition for removal of toxins
DE10149030A1 (de) * 2001-10-05 2003-04-10 Viscum Ag Stabile galenische gefriergetrocknete Arzneimittelzubereitung von rViscumin
EP2283856B1 (en) * 2002-06-21 2017-09-20 Novo Nordisk Health Care AG Stabilised solid compositions of factor VIIa polypeptides
KR100560697B1 (ko) 2003-08-06 2006-03-16 씨제이 주식회사 알부민을 함유하지 않는 에리스로포이에틴 제제

Also Published As

Publication number Publication date
EP2150264A4 (en) 2014-09-24
CN101678066B (zh) 2014-09-24
IL201508A0 (en) 2010-05-31
US20100113744A1 (en) 2010-05-06
WO2008134310A8 (en) 2009-12-10
CA2683317C (en) 2014-12-16
AU2008245821B2 (en) 2013-07-04
AU2008245821A1 (en) 2008-11-06
ZA200907247B (en) 2010-08-25
ECSP099704A (es) 2009-11-30
JP2010525071A (ja) 2010-07-22
JP5401446B2 (ja) 2014-01-29
KR101578561B1 (ko) 2015-12-17
US8187799B2 (en) 2012-05-29
BRPI0810500A2 (pt) 2014-10-14
WO2008134310A1 (en) 2008-11-06
CN101678066A (zh) 2010-03-24
RU2009143493A (ru) 2011-06-10
KR20150103333A (ko) 2015-09-09
EP2150264A1 (en) 2010-02-10
US20120211698A1 (en) 2012-08-23
KR20100017354A (ko) 2010-02-16
CN103990116A (zh) 2014-08-20
CA2683317A1 (en) 2008-11-06
US8536125B2 (en) 2013-09-17
HK1198815A1 (en) 2015-06-12
RU2469739C2 (ru) 2012-12-20

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