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)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Cell Biology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Molecular Biology (AREA)
  • Toxicology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (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)

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CA2612937C (en) * 2005-07-22 2014-05-06 Amgen Inc. Concentrated protein lyophilates, methods, and uses
PE20081610A1 (es) * 2007-01-09 2008-12-09 Wyeth Corp Formulaciones de anticuerpos anti-il-13 y usos de los mismos
MX2009008692A (es) * 2007-02-16 2009-08-21 Wyeth Corp Uso de sacarosa para suprimir la agregacion de proteina inducida por manitol.
PT2219675E (pt) * 2007-11-12 2013-11-18 Ares Trading Sa Formulações para proteínas de fusão de taci-imunoglobulina
JO3672B1 (ar) 2008-12-15 2020-08-27 Regeneron Pharma أجسام مضادة بشرية عالية التفاعل الكيماوي بالنسبة لإنزيم سبتيليسين كنفرتيز بروبروتين / كيكسين نوع 9 (pcsk9).
UY32560A (es) 2009-04-29 2010-11-30 Bayer Schering Pharma Ag Inmunoconjugados de antimesotelina y usos de los mismos
MX2011013722A (es) * 2009-06-18 2012-05-08 Wyeth Llc Formulaciones liofilizadas para inmunofarmaceuticos modulares pequeños.
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
WO2011056793A2 (en) 2009-11-03 2011-05-12 Talecris Biotherapeutics, Inc. Composition, method, and kit for alpha-1 proteinase inhibitor
RU2540480C2 (ru) * 2009-11-24 2015-02-10 Грифольс Терапьютикс Инк. Способы, композиции и наборы для лиофилизации
JO3417B1 (ar) 2010-01-08 2019-10-20 Regeneron Pharma الصيغ المستقرة التي تحتوي على الأجسام المضادة لمضاد مستقبل( interleukin-6 (il-6r
KR20220136466A (ko) 2011-01-28 2022-10-07 사노피 바이오테크놀로지 특정 대상자 그룹의 치료 방법에 이용하기 위한 ｐｃｓｋ9에 대한 인간 항체
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
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
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
GB201513010D0 (en) * 2015-07-23 2015-09-09 Glaxosmithkline Biolog Sa Novel formulation
WO2017031151A1 (en) 2015-08-18 2017-02-23 Regeneron Pharmaceuticals, Inc. Anti-pcsk9 inhibitory antibodies for treating patients with hyperlipidemia undergoing lipoprotein apheresis
SG11202010684YA (en) 2018-05-10 2020-11-27 Regeneron Pharma High concentration vegf receptor fusion protein containing formulations
WO2020021330A2 (en) * 2018-07-12 2020-01-30 Endo Global Aesthetics Limited Injection techniques for the treatment of cellulite
WO2020088481A1 (zh) * 2018-10-30 2020-05-07 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
KR20210113271A (ko) * 2019-01-06 2021-09-15 엔도 글로벌 에스테틱스 리미티드 콜라게나제 제형 및 이의 제조 방법
KR20210122810A (ko) 2019-01-31 2021-10-12 사노피 바이오테크놀로지 청소년 특발성 관절염을 치료하기 위한 항 il-6 수용체 항체
CN120241997A (zh) 2019-02-18 2025-07-04 伊莱利利公司 治疗性抗体制剂
TW202106712A (zh) 2019-04-24 2021-02-16 美商再生元醫藥公司 類風溼性關節炎之診斷及治療方法
CA3142710A1 (en) 2019-06-04 2020-12-10 Sanofi Biotechnology Compositions and methods for treating pain in subjects with rheumatoid arthritis
CN113125489A (zh) * 2019-12-31 2021-07-16 上海药明生物技术有限公司 生物制剂配方优化和工艺优化的方法和系统
WO2022175663A1 (en) * 2021-02-17 2022-08-25 Arecor Limited Aqueous composition of an engineered protein construct comprising an fc domain
GB202102258D0 (en) * 2021-02-17 2021-03-31 Arecor Ltd Novel composition
AU2022236913A1 (en) * 2021-03-16 2023-10-26 Kashiv Biosciences, Llc Novel formulation of fusion protein

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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
US6685940B2 (en) * 1995-07-27 2004-02-03 Genentech, Inc. Protein formulation
EP2275119B1 (en) * 1995-07-27 2013-09-25 Genentech, Inc. Stable isotonic lyophilized 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
ES2435141T3 (es) * 1999-02-22 2013-12-18 University Of Connecticut Nuevas formulaciones de factor VIII libres de albúmina
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
SI1946776T1 (sl) * 2002-02-27 2017-07-31 Immunex Corporation Stabiliziran tnfr-fc sestavek, ki obsega arginin
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
CR10012A (es) 2008-07-29
CN101312744A (zh) 2008-11-26
WO2007062040A1 (en) 2007-05-31
JP2009516692A (ja) 2009-04-23
CA2630115A1 (en) 2007-05-31
EP1951305A1 (en) 2008-08-06
NO20082133L (no) 2008-06-16
RU2008118166A (ru) 2009-12-27
KR20080071192A (ko) 2008-08-01
AU2006318583A1 (en) 2007-05-31
SV2009002911A (es) 2009-03-04
US20110033464A1 (en) 2011-02-10
US20070237758A1 (en) 2007-10-11

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