ECSP088459A - Formulaciones de proteina de fusion de inmunoglobulina - Google Patents

Formulaciones de proteina de fusion de inmunoglobulina

Info

Publication number
ECSP088459A
ECSP088459A EC2008008459A ECSP088459A ECSP088459A EC SP088459 A ECSP088459 A EC SP088459A EC 2008008459 A EC2008008459 A EC 2008008459A EC SP088459 A ECSP088459 A EC SP088459A EC SP088459 A ECSP088459 A EC SP088459A
Authority
EC
Ecuador
Prior art keywords
fusion protein
compositions
immunoglobulin fusion
protein formulations
lyophilized
Prior art date
Application number
EC2008008459A
Other languages
English (en)
Inventor
Li Li
Nicholas W Warne
Anthony Barry
Thomas Crowley
Jenier Juneau
Ajay Kumar
Nicholas Luksha
Michael Shamashkin
Erin Soley
Daniel Dixon
Chandra Webb
Original Assignee
Wyeth Corp
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 Wyeth Corp filed Critical Wyeth Corp
Publication of ECSP088459A publication Critical patent/ECSP088459A/es

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/715—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • C07K14/7155—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons for interleukins [IL]
    • 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
    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/1774—Immunoglobulin superfamily (e.g. CD2, CD4, CD8, ICAM molecules, B7 molecules, Fc-receptors, MHC-molecules)
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/31—Fusion polypeptide fusions, other than Fc, for prolonged plasma life, e.g. albumin

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Cell Biology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Toxicology (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

La presente invención se refiere a composiciones de proteínas de fusión de Ig, especialmente composiciones que incluyen una proteína de fusión de Ig, un agente de volumen, un disacárido, un tensioactivo, y un amortiguador. En un aspecto, estas composiciones son estables bajo almacenamiento a largo plazo o al menos un ciclo de congelación/descongelación. La invención también proporciona métodos de preparación de las composiciones de proteína de fusión de Ig. En un aspecto, las composiciones de la invención son liofilizadas. En un aspecto adicional, las composiciones son liofilizadas por un proceso que incluye una etapa de recocido.
EC2008008459A 2005-11-22 2008-05-19 Formulaciones de proteina de fusion de inmunoglobulina ECSP088459A (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US73927105P 2005-11-22 2005-11-22

Publications (1)

Publication Number Publication Date
ECSP088459A true ECSP088459A (es) 2008-06-30

Family

ID=37781927

Family Applications (1)

Application Number Title Priority Date Filing Date
EC2008008459A ECSP088459A (es) 2005-11-22 2008-05-19 Formulaciones de proteina de fusion de inmunoglobulina

Country Status (14)

Country Link
US (2) US20070237758A1 (es)
EP (1) EP1951305A1 (es)
JP (1) JP2009516692A (es)
KR (1) KR20080071192A (es)
CN (1) CN101312744A (es)
AU (1) AU2006318583A1 (es)
BR (1) BRPI0618893A2 (es)
CA (1) CA2630115A1 (es)
CR (1) CR10012A (es)
EC (1) ECSP088459A (es)
NO (1) NO20082133L (es)
RU (1) RU2008118166A (es)
SV (1) SV2009002911A (es)
WO (1) WO2007062040A1 (es)

Families Citing this family (23)

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Publication number Priority date Publication date Assignee Title
CA2612937C (en) * 2005-07-22 2014-05-06 Amgen Inc. Concentrated protein lyophilates, methods, and uses
CL2008000058A1 (es) * 2007-01-09 2008-05-23 Wyeth Corp Formulacion que comprende un anticuerpo anti-il13, un criprotector, y una solucion amortiguadora; composicion farmaceutica que la comprende; metodo para tratar un trastorno relacionado con il13; y formas farmaceuticas que la comprenden.
WO2008101179A2 (en) * 2007-02-16 2008-08-21 Wyeth Use of sucrose to suppress mannitol-induced protein aggregation
ES2436779T3 (es) * 2007-11-12 2014-01-07 Ares Trading S.A. Formulaciones para proteínas de fusión TACI-inmunoglobulina
UY32560A (es) 2009-04-29 2010-11-30 Bayer Schering Pharma Ag Inmunoconjugados de antimesotelina y usos de los mismos
EP2442798A4 (en) * 2009-06-18 2013-03-13 Wyeth Llc LYOPHILIZED FORMULATIONS FOR SMALL-SCALE MODULAR IMMUNOPHARMACEUTICAL AGENTS
CN101693016B (zh) * 2009-11-02 2012-07-25 北京美福源生物医药科技有限公司 通用的注射用重组人血清白蛋白融合蛋白制剂配方
JP2013510158A (ja) 2009-11-03 2013-03-21 グリフオルス・セラピユーテイクス・インコーポレーテツド α‐１プロテイナーゼインヒビターのための組成物、方法およびキット
WO2011066291A2 (en) * 2009-11-24 2011-06-03 Talecris Biotherapeutics, Inc. Lyophilization methods, compositions, and kits
JO3417B1 (ar) 2010-01-08 2019-10-20 Regeneron Pharma الصيغ المستقرة التي تحتوي على الأجسام المضادة لمضاد مستقبل( interleukin-6 (il-6r
AR087305A1 (es) 2011-07-28 2014-03-12 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit
TWI589299B (zh) 2011-10-11 2017-07-01 再生元醫藥公司 用於治療類風濕性關節炎之組成物及其使用方法
CN105435222B (zh) * 2014-09-25 2018-05-29 信达生物制药(苏州)有限公司 重组融合蛋白制剂
CN104940926B (zh) * 2014-09-25 2017-09-22 信达生物制药(苏州)有限公司 重组融合蛋白制剂
GB201513010D0 (en) 2015-07-23 2015-09-09 Glaxosmithkline Biolog Sa Novel formulation
MA42657A (fr) 2015-08-18 2018-06-27 Regeneron Pharma Anticorps inhibiteurs anti-pcsk9 destinés au traitement des patients atteints d'hyperlipidémie subissant une aphérèse de lipoprotéines
CN112739323A (zh) 2018-05-10 2021-04-30 瑞泽恩制药公司 含有高浓度vegf受体融合蛋白的制剂
WO2020021330A2 (en) * 2018-07-12 2020-01-30 Endo Global Aesthetics Limited Injection techniques for the treatment of cellulite
CN110607554B (zh) * 2018-10-30 2024-03-22 中国科学院化学研究所 一种制备药物或药物中间体单晶或无定型物的方法
CN111195349B (zh) * 2018-11-16 2023-02-24 鲁南制药集团股份有限公司 一种代谢调节融合蛋白的冻干粉制剂
BR112021012675A2 (pt) * 2019-01-06 2021-09-28 Endo Global Aesthetics Limited Formulação, formulação liofilizada, formulação reconstituída e kit
US11498969B2 (en) 2019-01-31 2022-11-15 Sanofi Biotechnology Compositions and methods for treating juvenile idiopathic arthritis
CA3129901A1 (en) 2019-02-18 2020-08-27 Eli Lilly And Company Therapeutic antibody formulation

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4597966A (en) * 1985-01-09 1986-07-01 Ortho Diagnostic Systems, Inc. Histidine stabilized immunoglobulin and method of preparation
US5843707A (en) * 1992-10-23 1998-12-01 Genetics Institute, Inc. Nucleic acid encoding a novel P-selectin ligand protein
US6372716B1 (en) * 1994-04-26 2002-04-16 Genetics Institute, Inc. Formulations for factor IX
EP1516628B1 (en) * 1995-07-27 2013-08-21 Genentech, Inc. Stable isotonic lyophilized protein formulation
US6685940B2 (en) * 1995-07-27 2004-02-03 Genentech, Inc. Protein formulation
US5763401A (en) * 1996-07-12 1998-06-09 Bayer Corporation Stabilized albumin-free recombinant factor VIII preparation having a low sugar content
JP3900664B2 (ja) * 1997-09-26 2007-04-04 株式会社ニコン 顕微鏡
US7198789B2 (en) * 1998-03-17 2007-04-03 Genetics Institute, Llc Methods and compositions for modulating interleukin-21 receptor activity
BR0008405B1 (pt) * 1999-02-22 2014-04-22 Baxter Int Composição de fator viii formulada sem a adição de albumina, uso de uma composição de fator viii, e, método de liofilizar uma formulação farmacêutica aquosa
WO2000066160A1 (fr) * 1999-04-28 2000-11-09 Yamanouchi Pharmaceutical Co., Ltd. Composition medicamenteuse parenterale a fragment d'anticorps monoclonal humanise et procede de stabilisation
AU2003219958B2 (en) * 2002-02-27 2006-01-05 Immunex Corporation Polypeptide formulation
EP1720519A1 (en) * 2004-03-04 2006-11-15 Wyeth Lyophilization method to improve excipient crystallization

Also Published As

Publication number Publication date
BRPI0618893A2 (pt) 2011-09-13
EP1951305A1 (en) 2008-08-06
AU2006318583A1 (en) 2007-05-31
JP2009516692A (ja) 2009-04-23
CA2630115A1 (en) 2007-05-31
KR20080071192A (ko) 2008-08-01
US20110033464A1 (en) 2011-02-10
RU2008118166A (ru) 2009-12-27
CN101312744A (zh) 2008-11-26
WO2007062040A1 (en) 2007-05-31
US20070237758A1 (en) 2007-10-11
NO20082133L (no) 2008-06-16
CR10012A (es) 2008-07-29
SV2009002911A (es) 2009-03-04

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