MX2016012447A - Formulaciones de factor ix liofilizadas. - Google Patents

Formulaciones de factor ix liofilizadas.

Info

Publication number
MX2016012447A
MX2016012447A MX2016012447A MX2016012447A MX2016012447A MX 2016012447 A MX2016012447 A MX 2016012447A MX 2016012447 A MX2016012447 A MX 2016012447A MX 2016012447 A MX2016012447 A MX 2016012447A MX 2016012447 A MX2016012447 A MX 2016012447A
Authority
MX
Mexico
Prior art keywords
fix
polypeptide
formulations
present
factor
Prior art date
Application number
MX2016012447A
Other languages
English (en)
Inventor
M Thome Brian
Parkhurst-Lang Cherie
W Leveille Brandon
Original Assignee
Biogen Ma 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=54196282&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=MX2016012447(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Biogen Ma Inc filed Critical Biogen Ma Inc
Publication of MX2016012447A publication Critical patent/MX2016012447A/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
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482—Serine endopeptidases (3.4.21)
    • A61K38/4846—Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
    • 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
    • A61K9/0012—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
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21—Serine endopeptidases (3.4.21)
    • C12Y304/21022—Coagulation factor IXa (3.4.21.22)
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26—DRYING
    • F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B5/00—Drying solid materials or objects by processes not involving the application of heat
    • F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
    • F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing

Landscapes

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

Abstract

La presente invención provee, entre otras cosas, formulaciones pre- liofilización, formulaciones reconstituidas y formulaciones de polvo liofilizado que comprenden un polipéptido de Factor IX (FIX). La presente invención proporciona también métodos de liofilización para producir un polvo liofilizado que comprende un polipéptido de FIX. La presente invención se refiere a una formulación pre-liofilización que comprende: (a) un polipéptido (FIX) de Factor IX que tiene actividad de coagulación FIX; (b) un agente amortiguador; (c) un agente estabilizante; (d) un agente espesante; y (e) un tensioactivo, donde la formulación tiene un volumen de relleno menor que alrededor de 5 mL y donde cada uno de (a) - (e) se encuentran en una cantidad por vial (mg/vial) suficiente para permitir (1) mejor estabilidad del polipéptido de FIX al liofilizarse.
MX2016012447A 2014-03-24 2015-03-24 Formulaciones de factor ix liofilizadas. MX2016012447A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201461969801P 2014-03-24 2014-03-24
PCT/US2015/022141 WO2015148444A1 (en) 2014-03-24 2015-03-24 Lyophilized factor ix formulations

Publications (1)

Publication Number Publication Date
MX2016012447A true MX2016012447A (es) 2017-01-06

Family

ID=54196282

Family Applications (2)

Application Number Title Priority Date Filing Date
MX2016012447A MX2016012447A (es) 2014-03-24 2015-03-24 Formulaciones de factor ix liofilizadas.
MX2021012939A MX2021012939A (es) 2014-03-24 2016-09-23 Formulaciones de factor ix liofilizadas.

Family Applications After (1)

Application Number Title Priority Date Filing Date
MX2021012939A MX2021012939A (es) 2014-03-24 2016-09-23 Formulaciones de factor ix liofilizadas.

Country Status (17)

Country Link
US (2) US10772942B2 (es)
EP (1) EP3123090A4 (es)
JP (4) JP7058940B2 (es)
KR (1) KR102385372B1 (es)
AR (1) AR099838A1 (es)
AU (3) AU2015236340B2 (es)
BR (1) BR112016021777A2 (es)
CA (1) CA2943034C (es)
CL (1) CL2016002386A1 (es)
EA (2) EA202092926A3 (es)
IL (3) IL247869B (es)
MA (1) MA39779A (es)
MX (2) MX2016012447A (es)
PH (1) PH12016501877A1 (es)
SG (3) SG10201808249VA (es)
TW (1) TWI700101B (es)
WO (1) WO2015148444A1 (es)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG10201707600XA (en) 2013-03-15 2017-11-29 Biogen Ma Inc Factor ix polypeptide formulations
MX2016012447A (es) 2014-03-24 2017-01-06 Biogen Ma Inc Formulaciones de factor ix liofilizadas.
BR112020000592A2 (pt) * 2017-07-11 2020-07-14 Universal Stabilization Technologies, Inc. método para conservar materiais biológicos
CN112175088B (zh) * 2019-07-02 2023-03-28 江苏晟斯生物制药有限公司 改进的fix融合蛋白、缀合物及其应用
CN115867307A (zh) * 2020-05-11 2023-03-28 奥克梅斯制药爱尔兰有限公司 Il-2融合多肽组合物以及其制备和使用方法

Family Cites Families (51)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0154316B1 (en) 1984-03-06 1989-09-13 Takeda Chemical Industries, Ltd. Chemically modified lymphokine and production thereof
DE68925966T2 (de) 1988-12-22 1996-08-29 Kirin Amgen Inc Chemisch modifizierte granulocytenkolonie erregender faktor
DK0461200T3 (da) 1989-02-21 1997-03-10 Univ Washington Modificerede former af reproduktionshormoner
US6552170B1 (en) 1990-04-06 2003-04-22 Amgen Inc. PEGylation reagents and compounds formed therewith
ATE240740T1 (de) 1991-03-15 2003-06-15 Amgen Inc Pegylation von polypeptiden
FR2686899B1 (fr) 1992-01-31 1995-09-01 Rhone Poulenc Rorer Sa Nouveaux polypeptides biologiquement actifs, leur preparation et compositions pharmaceutiques les contenant.
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
DE4405426A1 (de) 1994-02-21 1995-08-24 Boehringer Mannheim Gmbh Pharmazeutisches Präparat enthaltend Plasminogenaktivator (t-PA) oder dessen Derivate
US6372716B1 (en) 1994-04-26 2002-04-16 Genetics Institute, Inc. Formulations for factor IX
US6685940B2 (en) 1995-07-27 2004-02-03 Genentech, Inc. Protein formulation
US5770700A (en) 1996-01-25 1998-06-23 Genetics Institute, Inc. Liquid factor IX formulations
IN184589B (es) 1996-10-16 2000-09-09 Alza Corp
JP2001151694A (ja) 1999-09-17 2001-06-05 Takeda Chem Ind Ltd タンパク質粉体の製造法
EP1219298A4 (en) 1999-09-17 2003-06-11 Takeda Chemical Industries Ltd PROCESS FOR PRODUCING PROTEIN POWDER
US7091321B2 (en) 2000-02-11 2006-08-15 Emd Lexigen Research Center Corp. Enhancing the circulating half-life of antibody-based fusion proteins
WO2002040544A2 (en) 2000-11-14 2002-05-23 Board Of Regents, University Of Texas Systems Mutant human factor ix with an increased resistance to inhibition by heparin
RU2004110239A (ru) 2001-09-04 2005-10-20 Мерк Патент ГмбХ (DE) Модифицированный фактор ix
EP1463751B1 (en) 2001-12-21 2013-05-22 Human Genome Sciences, Inc. Albumin fusion proteins
US7348004B2 (en) 2003-05-06 2008-03-25 Syntonix Pharmaceuticals, Inc. Immunoglobulin chimeric monomer-dimer hybrids
ES2333598T5 (es) 2003-05-06 2013-09-04 Biogen Idec Hemophilia Inc Proteinas quimericas del factor de coagulacion fc para tratar la hemofilia.
JP2005060378A (ja) 2003-07-28 2005-03-10 Yamanouchi Pharmaceut Co Ltd 生理活性蛋白質含有凍結乾燥製剤
US20050152979A1 (en) 2003-09-05 2005-07-14 Cell Therapeutics, Inc. Hydrophobic drug compositions containing reconstitution enhancer
WO2005089712A1 (en) 2004-03-04 2005-09-29 Wyeth Lyophilization method to improve excipient crystallization
WO2006029467A1 (en) * 2004-09-16 2006-03-23 Btf Pty Ltd Rapid freeze drying process
CN101124331B (zh) 2004-11-12 2013-04-24 拜尔健康护理有限责任公司 Fvⅲ的位点定向修饰
US8367805B2 (en) 2004-11-12 2013-02-05 Xencor, Inc. Fc variants with altered binding to FcRn
WO2007014073A2 (en) 2005-07-22 2007-02-01 Amgen Inc. Concentrated protein lyophilates, methods, and uses
WO2007044616A2 (en) * 2005-10-06 2007-04-19 Xencor, Inc. Optimized anti-cd30 antibodies
EP1942868B2 (en) * 2005-11-01 2023-10-04 Wyeth LLC Sodium chloride solution for drug reconstitution or dilution
US8048848B2 (en) 2006-02-03 2011-11-01 Prolor Biotech Ltd. Long-acting interferons and derivatives thereof and methods thereof
HUE042402T2 (hu) 2006-04-04 2019-06-28 Chiesi Farm Spa Eljárás polipeptid töményítésére
EP2423307A1 (en) 2006-06-19 2012-02-29 Catalyst Biosciences, Inc. Modified coagulation factor IV polypeptides and use thereof for treatment
US8015841B2 (en) * 2006-09-08 2011-09-13 Praxair Technology, Inc. Cryogenic refrigeration system for lyophilization
US7700734B2 (en) 2007-01-09 2010-04-20 Shu-Wha Lin Recombinant human factor IX and use thereof
DK2173890T3 (da) 2007-06-21 2011-06-27 Univ Muenchen Tech Biologisk aktive proteiner med forhøjet stabilitet in vivo og/eller in vitro
EP2209487A4 (en) 2007-10-15 2012-06-20 Univ North Carolina VARIANTS OF HUMAN FACTOR IX WITH EXTENDED HALF-TIME
KR20100110799A (ko) 2007-12-27 2010-10-13 백스터 인터내셔널 인코포레이티드 화학적으로 변형된 제 ９ 인자
KR20110015551A (ko) 2008-04-16 2011-02-16 바이엘 헬스케어 엘엘씨 제ｉｘ인자의 부위-지정 변형
AU2009244633A1 (en) 2008-04-16 2009-11-12 Bayer Healthcare Llc Modified Factor IX polypeptides and uses thereof
EP2268807A2 (en) 2008-04-21 2011-01-05 Novo Nordisk A/S Hyperglycosylated human coagulation factor ix
CA2729972C (en) 2008-08-05 2018-11-20 Wyeth Llc Lyophilization above collapse
BRPI0918988A2 (pt) 2008-09-24 2015-12-01 Stabilitech Ltd métodos para preservar um polipeptídeo e um imunógeno de vacina, e para preparar uma vacina, pó seco, produto preservado, frasco selado, ampola ou seringa, uso de um excipiente, e, vacina.
AU2010263058A1 (en) 2009-06-18 2012-01-12 Wyeth Llc Lyophilized formulations for small modular immunopharmaceuticals
WO2011017070A1 (en) * 2009-07-28 2011-02-10 Merck Sharp & Dohme Corp. Methods for producing high concentration lyophilized pharmaceutical formulations
KR20140017480A (ko) * 2010-07-09 2014-02-11 바이오겐 이데크 헤모필리아 인코포레이티드 인자 iｘ 폴리펩티드 및 이들의 사용 방법
ES2561878T3 (es) 2010-09-30 2016-03-01 Toyama Chemical Co., Ltd. Sal de meglumina de 6-fluoro-3-hidroxi-2-pirazinacarboxamida
EP2672986B1 (en) 2011-02-09 2020-03-18 GlaxoSmithKline LLC Lyophilized formulations
AU2013270682A1 (en) 2012-06-08 2014-12-11 Biogen Ma Inc. Procoagulant compounds
TWI750197B (zh) * 2012-09-25 2021-12-21 美商百歐維拉提夫治療公司 Ｆｉｘ多肽的應用
SG10201707600XA (en) * 2013-03-15 2017-11-29 Biogen Ma Inc Factor ix polypeptide formulations
MX2016012447A (es) * 2014-03-24 2017-01-06 Biogen Ma Inc Formulaciones de factor ix liofilizadas.

Also Published As

Publication number Publication date
IL272257B (en) 2021-03-25
IL247869A0 (en) 2016-11-30
CL2016002386A1 (es) 2017-06-23
JP2017510585A (ja) 2017-04-13
IL272257A (en) 2020-02-27
MX2021012939A (es) 2021-11-25
TWI700101B (zh) 2020-08-01
IL281197B (en) 2022-06-01
CA2943034C (en) 2022-06-14
NZ724351A (en) 2023-10-27
SG10201913735SA (en) 2020-03-30
MA39779A (fr) 2017-02-01
JP2020063313A (ja) 2020-04-23
TW201605492A (zh) 2016-02-16
EA038573B1 (ru) 2021-09-16
AU2020202863B2 (en) 2022-09-01
IL281197A (en) 2021-04-29
EP3123090A4 (en) 2017-12-13
JP7058940B2 (ja) 2022-04-25
US10772942B2 (en) 2020-09-15
AU2015236340A1 (en) 2016-09-29
AR099838A1 (es) 2016-08-24
SG11201607642RA (en) 2016-10-28
AU2020202863A1 (en) 2020-05-21
SG10201808249VA (en) 2018-10-30
PH12016501877A1 (en) 2016-12-19
CA2943034A1 (en) 2015-10-01
WO2015148444A1 (en) 2015-10-01
US20170173122A1 (en) 2017-06-22
AU2015236340B2 (en) 2020-02-06
EA202092926A3 (ru) 2021-10-29
EA201691807A1 (ru) 2017-03-31
EP3123090A1 (en) 2017-02-01
KR102385372B1 (ko) 2022-04-11
KR20160137577A (ko) 2016-11-30
JP2024053015A (ja) 2024-04-12
EA202092926A2 (ru) 2021-07-30
BR112016021777A2 (pt) 2017-10-03
IL247869B (en) 2020-02-27
US20210069307A1 (en) 2021-03-11
AU2022215218A1 (en) 2022-09-01
JP2022044689A (ja) 2022-03-17

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