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AR116112A2 - COMPOSICIÓN FARMACÉUTICA LÍQUIDA CON ESTABILIDAD EN EL LARGO PLAZO DE UN FACTOR VON WILLEBRAND (rVWF) RECOMBINANTE - Google Patents

COMPOSICIÓN FARMACÉUTICA LÍQUIDA CON ESTABILIDAD EN EL LARGO PLAZO DE UN FACTOR VON WILLEBRAND (rVWF) RECOMBINANTE

Info

Publication number
AR116112A2
AR116112A2 ARP190102509A ARP190102509A AR116112A2 AR 116112 A2 AR116112 A2 AR 116112A2 AR P190102509 A ARP190102509 A AR P190102509A AR P190102509 A ARP190102509 A AR P190102509A AR 116112 A2 AR116112 A2 AR 116112A2
Authority
AR
Argentina
Prior art keywords
rvwf
group
pharmaceutical composition
long
term stability
Prior art date
Application number
ARP190102509A
Other languages
English (en)
Original Assignee
Baxalta GmbH
Baxalta 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=40602549&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AR116112(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Baxalta GmbH, Baxalta Inc filed Critical Baxalta GmbH
Publication of AR116112A2 publication Critical patent/AR116112A2/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D61/00Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Water Supply & Treatment (AREA)
  • Peptides Or Proteins (AREA)
  • Separation Using Semi-Permeable Membranes (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)

Abstract

Composición farmacéutica líquida con estabilidad en el largo plazo de un Factor von Willebrand (rVWF) recombinante que comprende: (a) un rVWF; (b) un agente amortiguador, (c) una o más sales; (d) un agente estabilizante; y (e) un tensioactivo; donde dicho rVWF es capaz de causar la aglutinación de plaquetas estabilizadas en presencia de ristocetina; donde dicho rVWF comprende un polipéptido seleccionado del grupo integrado por: a) la secuencia de aminoácidos expuesta en la SEC ID Nº 3; y b) un polipéptido codificado por el polinucleótido que se establece en la SEC ID Nº 1; en donde dicho buffer está compuesto de un agente amortiguador de pH en un rango de 0,1 mM hasta 500 mM y donde el pH está en un rango de 2,0 hasta 12,0, en donde dicho agente amortiguador se selecciona del grupo que consiste en citrato de sodio, glicina, histidina, Tris, y combinaciones de estos agentes; donde dicha sal está a una concentración de 1 hasta 500 mM, en donde dicha sal se selecciona del grupo que consiste en cloruro de calcio y cloruro de sodio; donde dicho agente estabilizante está a una concentración de 0,1 a 1000 mM y se selecciona del grupo integrado por manitol, sacarosa, trehalosa, rafinosa, y combinaciones de estos agentes estabilizantes; y donde dicho tensioactivo está a una concentración de aproximadamente 0,01 g/L a 0,5 g/L, en donde dicho tensioactivo es polisorbato-80.
ARP190102509A 2007-12-28 2019-09-03 COMPOSICIÓN FARMACÉUTICA LÍQUIDA CON ESTABILIDAD EN EL LARGO PLAZO DE UN FACTOR VON WILLEBRAND (rVWF) RECOMBINANTE AR116112A2 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US1741807P 2007-12-28 2007-12-28

Publications (1)

Publication Number Publication Date
AR116112A2 true AR116112A2 (es) 2021-03-31

Family

ID=40602549

Family Applications (2)

Application Number Title Priority Date Filing Date
ARP080105761A AR070061A1 (es) 2007-12-28 2008-12-29 Filtracion por contrapresion de proteinas
ARP190102509A AR116112A2 (es) 2007-12-28 2019-09-03 COMPOSICIÓN FARMACÉUTICA LÍQUIDA CON ESTABILIDAD EN EL LARGO PLAZO DE UN FACTOR VON WILLEBRAND (rVWF) RECOMBINANTE

Family Applications Before (1)

Application Number Title Priority Date Filing Date
ARP080105761A AR070061A1 (es) 2007-12-28 2008-12-29 Filtracion por contrapresion de proteinas

Country Status (18)

Country Link
US (4) US7959809B2 (es)
EP (2) EP2242479B1 (es)
JP (4) JP5027310B2 (es)
KR (3) KR101915445B1 (es)
CN (1) CN101909599B (es)
AR (2) AR070061A1 (es)
AT (1) ATE525062T1 (es)
AU (1) AU2008345218B2 (es)
CA (1) CA2709781C (es)
DK (1) DK2242479T3 (es)
ES (1) ES2377038T3 (es)
HR (1) HRP20110927T1 (es)
NZ (2) NZ586316A (es)
PL (1) PL2242479T3 (es)
PT (1) PT2242479E (es)
SG (1) SG187411A1 (es)
SI (1) SI2242479T1 (es)
WO (1) WO2009086296A2 (es)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7959809B2 (en) * 2007-12-28 2011-06-14 Baxter International Inc. Counter-pressure filtration of proteins
TWI469992B (zh) * 2008-08-28 2015-01-21 Baxter Int 濃縮剪切靈敏生物聚合物的方法
US10100594B2 (en) * 2013-06-27 2018-10-16 Ge Oil & Gas Uk Limited Control system and a method for monitoring a filter in an underwater hydrocarbon well
SG11201605862WA (en) * 2014-01-20 2016-08-30 Eveon Process for reconstitution of a solid form of a pharmaceutical composition

Family Cites Families (29)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2624373C2 (de) * 1976-05-31 1983-02-03 Arnold Dr. 8782 Karlstadt Seufert Verfahren zur Herstellung von steril filtriertem Kryopräzipilat mit einer Anreicherung des Faktors VIII
US5047154A (en) * 1983-03-10 1991-09-10 C.P.C. Engineering Company Method and apparatus for enhancing the flux rate of cross-flow filtration systems
SE443075B (sv) * 1984-06-01 1986-02-17 Alfa Laval Agri Int Forfarande och anordning for framstellning av mjolkkoncentrat genom membranfiltrering
EP0168342B1 (de) * 1984-06-14 1991-07-03 Ciba-Geigy Ag Verfahren zur Herstellung von Thrombin-Inhibitoren
CA1339946C (en) 1987-03-31 1998-07-07 Michael J. Griffith Ultrapurification process for polypeptides
US4774323A (en) 1987-06-29 1988-09-27 Rorer Pharmaceutical Corporation Purification of von Willebrand Factor solutions using gel permeation chromatography
DE3730868A1 (de) 1987-09-15 1989-03-23 Henkel Kgaa Verfahren zur abtrennung von biotechnisch hergestellten wertstoffen aus einer fermenterbruehe durch querstrom-mikro- und/oder ultrafiltration
SE9003452L (sv) 1990-10-30 1992-05-01 Teinvall Sjoeberg & Broberg Ab Saett och anordning vid vaetskefiltrering
CH687055A5 (de) * 1993-12-03 1996-09-13 Bucher Guyer Ag Masch Verfahren und Vorrichtung zum Eindicken von Fest/Fluessig-Gemischen mittels Membrantechnologie.
US5525144A (en) * 1995-04-20 1996-06-11 A/G Technology Corporation Tangential flow filtering and separating
AT403764B (de) 1996-03-15 1998-05-25 Immuno Ag Stabiler faktor viii/vwf-komplex
US6193891B1 (en) * 1996-07-10 2001-02-27 American National Red Cross Methods for the selective separation of organic components from biological fluids
US5888401A (en) * 1996-09-16 1999-03-30 Union Camp Corporation Method and apparatus for reducing membrane fouling
AT406867B (de) 1997-02-27 2000-10-25 Immuno Ag Verfahren zur gewinnung von hochreinem vwf oder faktor viii/vwf-komplex
US5947689A (en) * 1997-05-07 1999-09-07 Scilog, Inc. Automated, quantitative, system for filtration of liquids having a pump controller
FR2772381B1 (fr) * 1997-12-15 2001-06-08 Lab Francais Du Fractionnement Procede de preparation par filtration d'une solution de facteur viii securisee viralement
US6139878A (en) 1998-04-27 2000-10-31 Aventis Behring, Llc Method for preparing a diafiltered stabilized blood product
MXPA01002908A (es) * 1998-09-21 2002-04-08 E Purdum Howard Metodos y aparatos para procesar materiales sensibles a la temperatura.
DE19964370B4 (de) * 1999-02-16 2006-05-11 Huss, Manfred Herstellung eines geschäumten Molkenproteinprodukts
US6623781B2 (en) * 1999-07-26 2003-09-23 Cornell Research Foundation, Inc. Microfiltration of skim milk for cheese making and whey proteins
US6485762B1 (en) * 1999-07-26 2002-11-26 Cornell Research Foundation, Inc. Microfiltration of skim milk for cheese making and whey proteins
DE10211227A1 (de) * 2002-03-13 2003-10-02 Aventis Behring Gmbh Verfahren zur Rekonstitution von Iyophilisierten Proteinen
SE522048C2 (sv) 2002-05-17 2004-01-07 Hemapure Ab Anordning och system för filtrering av blod
JP4587213B2 (ja) * 2002-06-17 2010-11-24 旭化成クラレメディカル株式会社 生体適合性ポリマーおよびそれを用いた白血球選択除去フィルター材
ES2214967B1 (es) 2003-03-06 2005-06-16 Probitas Pharma, S.A Procedimiento para la eliminacion de virus en soluciones de fibrinogeno y fibrinogeno obtenido por dicho procedimiento.
US7785594B2 (en) * 2003-08-14 2010-08-31 Life Sciences Research Partners Vzw Factor VIII inhibitory antibodies with reduced glycosylation
FR2861395B1 (fr) 2003-10-23 2006-02-17 Lab Francais Du Fractionnement Facteur viii viralement securise a faible teneur en multimeres superieurs
CA2602944C (en) * 2005-04-11 2015-08-11 Crucell Holland B.V. Virus purification using ultrafiltration
US7959809B2 (en) * 2007-12-28 2011-06-14 Baxter International Inc. Counter-pressure filtration of proteins

Also Published As

Publication number Publication date
KR101839278B1 (ko) 2018-03-15
KR20170070255A (ko) 2017-06-21
US8075781B2 (en) 2011-12-13
ES2377038T3 (es) 2012-03-21
US20090188862A1 (en) 2009-07-30
SI2242479T1 (sl) 2012-01-31
ATE525062T1 (de) 2011-10-15
US20120136139A1 (en) 2012-05-31
US20100317081A1 (en) 2010-12-16
BRPI0821599A2 (pt) 2015-06-16
AU2008345218A1 (en) 2009-07-09
JP5925817B2 (ja) 2016-05-25
CA2709781C (en) 2017-03-14
CA2709781A1 (en) 2009-07-09
WO2009086296A3 (en) 2009-08-27
CN101909599A (zh) 2010-12-08
SG187411A1 (en) 2013-02-28
KR20100106485A (ko) 2010-10-01
AU2008345218B2 (en) 2015-02-19
JP5466263B2 (ja) 2014-04-09
KR101915445B1 (ko) 2018-11-05
EP2242479A2 (en) 2010-10-27
US7959809B2 (en) 2011-06-14
US8454833B2 (en) 2013-06-04
KR101748878B1 (ko) 2017-06-19
AR070061A1 (es) 2010-03-10
NZ586316A (en) 2012-06-29
JP2011507962A (ja) 2011-03-10
EP2392317A1 (en) 2011-12-07
PL2242479T3 (pl) 2012-02-29
JP5027310B2 (ja) 2012-09-19
NZ600053A (en) 2013-06-28
DK2242479T3 (da) 2012-01-02
JP2014166989A (ja) 2014-09-11
WO2009086296A2 (en) 2009-07-09
PT2242479E (pt) 2011-11-25
KR20180028559A (ko) 2018-03-16
JP2012144578A (ja) 2012-08-02
HRP20110927T1 (hr) 2012-02-29
HK1150750A1 (en) 2012-01-13
JP2016106131A (ja) 2016-06-16
EP2242479B1 (en) 2011-09-21
US20100314317A1 (en) 2010-12-16
CN101909599B (zh) 2012-11-21
US8075782B2 (en) 2011-12-13

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