CL2016002386A1 - Formulaciones de factor ix liofilizadas. - Google Patents

Formulaciones de factor ix liofilizadas.

Info

Publication number
CL2016002386A1
CL2016002386A1 CL2016002386A CL2016002386A CL2016002386A1 CL 2016002386 A1 CL2016002386 A1 CL 2016002386A1 CL 2016002386 A CL2016002386 A CL 2016002386A CL 2016002386 A CL2016002386 A CL 2016002386A CL 2016002386 A1 CL2016002386 A1 CL 2016002386A1
Authority
CL
Chile
Prior art keywords
fix
formulations
liofilized
polipeptide
agent
Prior art date
Application number
CL2016002386A
Other languages
English (en)
Spanish (es)
Inventor
Brian M Thome
Cherie Parkhurst-Lang
Brandon W Leveille
Original Assignee
Bioverativ Therapeutics 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=CL2016002386(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Bioverativ Therapeutics Inc filed Critical Bioverativ Therapeutics Inc
Publication of CL2016002386A1 publication Critical patent/CL2016002386A1/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482Serine endopeptidases (3.4.21)
    • A61K38/4846Factor 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)
    • 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
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y304/00Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21Serine endopeptidases (3.4.21)
    • C12Y304/21022Coagulation factor IXa (3.4.21.22)
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26DRYING
    • F26BDRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B5/00Drying solid materials or objects by processes not involving the application of heat
    • F26B5/04Drying 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
    • F26B5/06Drying 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)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (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)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Dermatology (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Mobile Radio Communication Systems (AREA)
  • Monitoring And Testing Of Transmission In General (AREA)
CL2016002386A 2014-03-24 2016-09-22 Formulaciones de factor ix liofilizadas. CL2016002386A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201461969801P 2014-03-24 2014-03-24

Publications (1)

Publication Number Publication Date
CL2016002386A1 true CL2016002386A1 (es) 2017-06-23

Family

ID=54196282

Family Applications (1)

Application Number Title Priority Date Filing Date
CL2016002386A CL2016002386A1 (es) 2014-03-24 2016-09-22 Formulaciones de factor ix liofilizadas.

Country Status (16)

Country Link
US (3) US10772942B2 (enExample)
EP (1) EP3123090A4 (enExample)
JP (4) JP7058940B2 (enExample)
KR (1) KR102385372B1 (enExample)
AR (1) AR099838A1 (enExample)
AU (2) AU2015236340B2 (enExample)
CA (1) CA2943034C (enExample)
CL (1) CL2016002386A1 (enExample)
EA (2) EA202092926A3 (enExample)
IL (3) IL247869B (enExample)
MA (1) MA39779A (enExample)
MX (2) MX387269B (enExample)
PH (1) PH12016501877A1 (enExample)
SG (3) SG10201913735SA (enExample)
TW (1) TWI700101B (enExample)
WO (1) WO2015148444A1 (enExample)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI788044B (zh) * 2013-03-15 2022-12-21 美商百歐維拉提夫治療公司 因子ix多肽調配物
SG10201913735SA (en) 2014-03-24 2020-03-30 Bioverativ Therapeutics Inc Lyophilized factor ix formulations
BR112019011115A2 (pt) * 2016-12-02 2019-10-01 Bioverativ Therapeutics Inc. métodos para tratar artropatia hemofílica usando fatores de coagulação quiméricos
MX2020000480A (es) * 2017-07-11 2020-09-10 Universal Stabilization Tech Inc Método para la conservación de material biológico.
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
MX2022009558A (es) 2020-02-04 2022-09-09 Regeneron Pharma Contenido de humedad residual objetivo para farmaco liofilizado.
JP2023526024A (ja) * 2020-05-11 2023-06-20 アルカームス ファーマ アイルランド リミテッド Il-2融合ポリペプチド組成物ならびにその作製及び使用方法
CN118557531B (zh) * 2024-08-02 2024-10-18 成都蓉生药业有限责任公司 一种重组人凝血因子VIII-Fc融合蛋白冻干制剂的制备方法

Family Cites Families (58)

* 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
WO1990006952A1 (fr) 1988-12-22 1990-06-28 Kirin-Amgen, Inc. Facteur de stimulation de colonies de granulocytes modifies chimiquement
WO1990009800A1 (en) 1989-02-21 1990-09-07 Washington University Modified forms of reproductive hormones
US6552170B1 (en) 1990-04-06 2003-04-22 Amgen Inc. PEGylation reagents and compounds formed therewith
DK0575545T3 (da) 1991-03-15 2003-09-15 Amgen Inc Pegylering af polypeptider
FR2686899B1 (fr) 1992-01-31 1995-09-01 Rhone Poulenc Rorer Sa Nouveaux polypeptides biologiquement actifs, leur preparation et compositions pharmaceutiques les contenant.
WO1994007510A1 (en) 1992-10-02 1994-04-14 Kabi Pharmacia Ab 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 (enExample) 1996-10-16 2000-09-09 Alza Corp
US20010031721A1 (en) 1999-05-05 2001-10-18 Chandra Webb Highly concentrated, lyophilized, and liquid factor IX formulations
JP2001151694A (ja) 1999-09-17 2001-06-05 Takeda Chem Ind Ltd タンパク質粉体の製造法
KR20020063853A (ko) * 1999-09-17 2002-08-05 다케다 야쿠힌 고교 가부시키가이샤 단백질 분체의 제조 방법
AU4314801A (en) 2000-02-11 2001-08-20 Lexigen Pharm 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
EP1427820A2 (en) 2001-09-04 2004-06-16 MERCK PATENT GmbH Modified factor ix
WO2003060071A2 (en) 2001-12-21 2003-07-24 Human Genome Sciences, Inc. Albumin fusion proteins
EP3552627A1 (en) 2003-05-06 2019-10-16 Bioverativ Therapeutics Inc. Clotting factor-fc chimeric proteins to treat hemophilia
US7348004B2 (en) 2003-05-06 2008-03-25 Syntonix Pharmaceuticals, Inc. Immunoglobulin chimeric monomer-dimer hybrids
TWI353991B (en) * 2003-05-06 2011-12-11 Syntonix Pharmaceuticals Inc Immunoglobulin chimeric monomer-dimer hybrids
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
EP2311437A1 (en) 2003-12-19 2011-04-20 Novo Nordisk Health Care AG Stabilised compositions of factor VII polypeptides
CA2554018A1 (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
US8367805B2 (en) 2004-11-12 2013-02-05 Xencor, Inc. Fc variants with altered binding to FcRn
LT2371856T (lt) 2004-11-12 2022-08-25 Bayer Healthcare Llc Fviii modifikacija, nukreipta į tam tikrą vietą
KR101283736B1 (ko) 2004-12-15 2013-07-08 스위디쉬 오르펀 바이오비트럼 에이비(피유비엘) 케라티노사이트 성장 인자의 치료학적 제형
EP2377554A1 (en) * 2005-07-22 2011-10-19 Amgen, Inc Concentrated protein lyophilates, methods and uses
EP1951757B1 (en) * 2005-10-06 2014-05-14 Xencor, Inc. Optimized anti-cd30 antibodies
BRPI0618133A2 (pt) 2005-11-01 2011-08-16 Wyeth Corp solução de cloreto de sódio para reconstituição ou diluição de droga
US8048848B2 (en) 2006-02-03 2011-11-01 Prolor Biotech Ltd. Long-acting interferons and derivatives thereof and methods thereof
EP2004683B1 (en) 2006-03-24 2016-05-11 Biogen Hemophilia Inc. Pc5 as a factor ix propeptide processing enzyme
KR101504969B1 (ko) 2006-04-04 2015-03-24 샤이어 파마슈티칼스 아일랜드 리미티드 폴리펩타이드의 농축 방법
TW200804416A (en) 2006-06-19 2008-01-16 Nautilus Technology Llc Modified coagulation factor IX 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
KR101631323B1 (ko) 2007-06-21 2016-06-17 엑스엘-프로테인 게엠베하 증가된 생체내 및/또는 시험관내 안정성을 갖는 생물학적 활성 단백질
CN102026653B (zh) 2007-10-15 2014-06-18 北卡罗来纳-查佩尔山大学 半衰期延长的人因子ⅸ变体
CN101903030A (zh) 2007-12-21 2010-12-01 灵感生物制药学有限公司 含海藻糖的稳定化因子ix制剂
NZ585835A (en) 2007-12-27 2012-07-27 Baxter Int Chemically modified factor IX comprising a hydrophilic polymer attached via a releasable linker
JP2011517950A (ja) 2008-04-16 2011-06-23 バイエル・ヘルスケア・エルエルシー 第ix因子の部位特異的修飾
WO2009137254A2 (en) 2008-04-16 2009-11-12 Bayer Healthcare Llc Modified factor ix polypeptides and uses thereof
WO2009130198A2 (en) 2008-04-21 2009-10-29 Novo Nordisk A/S Hyperglycosylated human coagulation factor ix
AU2009239641B2 (en) 2008-04-24 2013-11-07 Cantab Biopharmaceuticals Patents Limited Factor IX conjugates with extended half-lives
ES2755029T3 (es) 2008-08-05 2020-04-21 Wyeth Llc Liofilización por encima de la temperatura de colapso
CN102164943A (zh) 2008-09-24 2011-08-24 稳定技术有限公司 使用糖和聚乙烯亚胺保存多肽的方法
US20120114646A1 (en) 2009-06-18 2012-05-10 Wyeth Llc Lyophilized formulations for small modular immunopharmaceuticals
EP2458990B1 (en) * 2009-07-28 2016-03-30 Merck Sharp & Dohme Corp. Methods for producing high concentration lyophilized pharmaceutical formulations
EA028067B1 (ru) 2010-07-09 2017-10-31 Байоджен Хемофилия Инк. Способы контроля или предотвращения кровотечения или эпизодов кровотечения
US20130217708A1 (en) 2010-09-30 2013-08-22 Toyama Chemical Co., Ltd. Meglumine salt of 6-fluoro-3-hydroxy-2-pyrazine carboxamide
US10286037B2 (en) 2011-02-09 2019-05-14 Glaxosmithkline Llc Methods of producing lyophilized polypeptide composition formulations comprising volatile additives
WO2013185113A1 (en) 2012-06-08 2013-12-12 Biogen Idec Ma Inc. Procoagulant compounds
WO2014052490A1 (en) * 2012-09-25 2014-04-03 Biogen Idec Ma Inc. Methods of using fix polypeptides
TWI788044B (zh) 2013-03-15 2022-12-21 美商百歐維拉提夫治療公司 因子ix多肽調配物
SG10201913735SA (en) * 2014-03-24 2020-03-30 Bioverativ Therapeutics Inc Lyophilized factor ix formulations

Also Published As

Publication number Publication date
IL281197A (en) 2021-04-29
JP2017510585A (ja) 2017-04-13
SG10201913735SA (en) 2020-03-30
KR20160137577A (ko) 2016-11-30
EA201691807A1 (ru) 2017-03-31
AU2022215218A1 (en) 2022-09-01
AU2020202863A1 (en) 2020-05-21
NZ724351A (en) 2023-10-27
JP2020063313A (ja) 2020-04-23
TWI700101B (zh) 2020-08-01
SG11201607642RA (en) 2016-10-28
JP7503583B2 (ja) 2024-06-20
EP3123090A1 (en) 2017-02-01
IL272257B (en) 2021-03-25
EA202092926A3 (ru) 2021-10-29
JP2024053015A (ja) 2024-04-12
US20210069307A1 (en) 2021-03-11
US20170173122A1 (en) 2017-06-22
IL247869A0 (en) 2016-11-30
US12128092B2 (en) 2024-10-29
MA39779A (fr) 2017-02-01
CA2943034A1 (en) 2015-10-01
AR099838A1 (es) 2016-08-24
MX387269B (es) 2025-03-18
PH12016501877A1 (en) 2016-12-19
WO2015148444A1 (en) 2015-10-01
EA038573B1 (ru) 2021-09-16
IL272257A (en) 2020-02-27
AU2015236340B2 (en) 2020-02-06
JP7759978B2 (ja) 2025-10-24
IL247869B (en) 2020-02-27
US10772942B2 (en) 2020-09-15
US20250121042A1 (en) 2025-04-17
BR112016021777A2 (pt) 2017-10-03
JP2022044689A (ja) 2022-03-17
CA2943034C (en) 2022-06-14
MX2021012939A (es) 2021-11-25
AU2020202863B2 (en) 2022-09-01
MX2016012447A (es) 2017-01-06
AU2015236340A1 (en) 2016-09-29
SG10201808249VA (en) 2018-10-30
IL281197B (en) 2022-06-01
JP7058940B2 (ja) 2022-04-25
EA202092926A2 (ru) 2021-07-30
TW201605492A (zh) 2016-02-16
EP3123090A4 (en) 2017-12-13
KR102385372B1 (ko) 2022-04-11

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