CL2016002492A1 - Formulaciones de factor viii estables con bajo tenor de azúcar - glicina. - Google Patents

Formulaciones de factor viii estables con bajo tenor de azúcar - glicina.

Info

Publication number
CL2016002492A1
CL2016002492A1 CL2016002492A CL2016002492A CL2016002492A1 CL 2016002492 A1 CL2016002492 A1 CL 2016002492A1 CL 2016002492 A CL2016002492 A CL 2016002492A CL 2016002492 A CL2016002492 A CL 2016002492A CL 2016002492 A1 CL2016002492 A1 CL 2016002492A1
Authority
CL
Chile
Prior art keywords
glycine
factor viii
sugar content
low sugar
stable factor
Prior art date
Application number
CL2016002492A
Other languages
English (en)
Inventor
Rajiv Nayar
Original Assignee
Advantech Bioscience Farm Ltda
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 Advantech Bioscience Farm Ltda filed Critical Advantech Bioscience Farm Ltda
Publication of CL2016002492A1 publication Critical patent/CL2016002492A1/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
    • 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
    • A61K47/16—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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K9/14—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

Landscapes

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

Abstract

<p>FORMULACIONES DE FACTOR VIII ESTABLES, SIN ALBÚMINA, CON BAJA CONCENTRACIÓN DE AZÚCAR Y GLICINA.</p>
CL2016002492A 2014-04-01 2016-09-30 Formulaciones de factor viii estables con bajo tenor de azúcar - glicina. CL2016002492A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201461973281P 2014-04-01 2014-04-01

Publications (1)

Publication Number Publication Date
CL2016002492A1 true CL2016002492A1 (es) 2017-07-07

Family

ID=54241375

Family Applications (1)

Application Number Title Priority Date Filing Date
CL2016002492A CL2016002492A1 (es) 2014-04-01 2016-09-30 Formulaciones de factor viii estables con bajo tenor de azúcar - glicina.

Country Status (10)

Country Link
US (1) US9907835B2 (es)
EP (1) EP3126003A4 (es)
JP (1) JP2017509659A (es)
KR (1) KR20160146762A (es)
CN (1) CN106413741A (es)
AU (1) AU2015240353A1 (es)
CA (1) CA2944349A1 (es)
CL (1) CL2016002492A1 (es)
MX (1) MX2016012870A (es)
WO (1) WO2015149143A2 (es)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9855319B2 (en) 2014-04-01 2018-01-02 Advantech Bioscience Farmacêutica Ltda Stabilization of factor VIII without calcium as an excipient
EP3167877A1 (en) * 2015-11-12 2017-05-17 Bayer Pharma Aktiengesellschaft Method for the production of freeze-dried pellets comprising factor viii

Family Cites Families (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
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
US6200560B1 (en) 1998-10-20 2001-03-13 Avigen, Inc. Adeno-associated virus vectors for expression of factor VIII by target cells
DK1820516T3 (da) * 1999-02-22 2013-10-28 Univ Connecticut Nye albuminfrie faktor VIII-præparater
DE60024268T2 (de) * 1999-07-13 2006-08-03 Biovitrum Ab Zusammensetzungen mit stabilem faktor viii
US20040185535A1 (en) 2003-03-21 2004-09-23 Giles Wilson Industrial-scale serum-free production of recombinant FVII in mammalian cells
EP1233064A1 (en) 2001-02-09 2002-08-21 Aventis Behring Gesellschaft mit beschränkter Haftung Modified factor VIII cDNA and its use for the production of factor VIII
US20040229335A1 (en) 2003-05-15 2004-11-18 Introgen Therapeutics, Inc. Methods and compositions for the production of adenoviral vectors
KR100624013B1 (ko) 2004-06-25 2006-09-19 주식회사 녹십자홀딩스 동결건조된 알부민 비함유 재조합 사람 혈액응고 제 8인자 제제
CA2656558A1 (en) 2006-06-30 2008-01-10 The Regents Of The University Of Michigan Method of producing factor viii proteins by recombinant methods
US20090035807A1 (en) 2007-07-31 2009-02-05 Wyeth Analysis of polypeptide production
US8580554B2 (en) 2009-07-31 2013-11-12 Baxter International Inc. Method of producing a polypeptide or virus of interest in a continuous cell culture
EP3255153A1 (en) 2009-11-17 2017-12-13 E. R. Squibb & Sons, L.L.C. Methods for enhanced protein production
BR112013023167A2 (pt) 2011-03-11 2016-09-06 Univ São Paulo método para produção do fator viii humano recombinante, fator viii humano recombinante, produto farmacêutico, uso do fator viii humano recombinante, método para tratamento de doenças relacionadas à diminuição, inativação ou ausência de fator viii, uso da endoprotease spc6 e/ou da pace4 ai e/ou da pacesol e processamento proteolítico do fator viii humano recombinante
US8668886B2 (en) 2011-04-24 2014-03-11 Therapeutic Proteins International, LLC Separative bioreactor
KR20140084208A (ko) * 2011-10-18 2014-07-04 시에스엘 리미티드 정제된 인자 ｖｉｉｉ의 재구성 후의 안정성을 향상시키는 방법
WO2015120527A2 (en) 2014-02-17 2015-08-20 Advantech Bioscience Farmacêutica Ltda Enhancement of recombinant protein expression using a membrane-based cell retention system
WO2015143512A2 (en) 2014-03-23 2015-10-01 Advantech Bioscience Farmacêutica Ltda. Enhancement of recombinant protein expression with copper
US9855319B2 (en) 2014-04-01 2018-01-02 Advantech Bioscience Farmacêutica Ltda Stabilization of factor VIII without calcium as an excipient

Also Published As

Publication number Publication date
CN106413741A (zh) 2017-02-15
AU2015240353A1 (en) 2016-11-17
KR20160146762A (ko) 2016-12-21
EP3126003A4 (en) 2017-11-29
US20170065683A1 (en) 2017-03-09
JP2017509659A (ja) 2017-04-06
WO2015149143A2 (en) 2015-10-08
MX2016012870A (es) 2017-05-12
US9907835B2 (en) 2018-03-06
CA2944349A1 (en) 2015-10-08
EP3126003A2 (en) 2017-02-08
WO2015149143A3 (en) 2015-12-10

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