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)

Families Citing this family (32)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2377554A1 (en) * 2005-07-22 2011-10-19 Amgen, Inc Concentrated protein lyophilates, methods and uses
WO2008086395A2 (en) * 2007-01-09 2008-07-17 Wyeth Anti-il-13 antibody formulations and uses thereof
MX2009008692A (es) * 2007-02-16 2009-08-21 Wyeth Corp Uso de sacarosa para suprimir la agregacion de proteina inducida por manitol.
US8637021B2 (en) * 2007-11-12 2014-01-28 Ares Trading S.A. Formulations for TACI-immunoglobulin fusion proteins
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
CA2764180A1 (en) * 2009-06-18 2010-12-23 Wyeth Llc Lyophilized formulations for small modular immunopharmaceuticals
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
PT2496246T (pt) 2009-11-03 2018-07-31 Grifols Therapeutics Llc Composição, método e kit para o inibidor da alfa-1 protease
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
MX385311B (es) 2011-01-28 2025-03-18 Sanofi Biotechnology Anticuerpos humanos frente a pcsk9 para su uso en métodos de tratamiento de grupos concretos de pacientes.
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
EP3068803B1 (en) 2013-11-12 2021-01-20 Sanofi Biotechnology Dosing regimens for use with pcsk9 inhibitors
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
KR20240172758A (ko) 2015-08-18 2024-12-10 리제너론 파아마슈티컬스, 인크. 지단백질 분리반출술을 경험하고 있는 고지혈증을 갖는 환자를 치료하기 위한 항-pcsk9 억제성 항체
JP7235770B2 (ja) 2018-05-10 2023-03-08 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 高濃度ｖｅｇｆ受容体融合タンパク質を含む製剤
WO2020021330A2 (en) * 2018-07-12 2020-01-30 Endo Global Aesthetics Limited Injection techniques for the treatment of cellulite
CN118267895A (zh) * 2018-10-30 2024-07-02 中国科学院化学研究所 一种制备药物或药物中间体无定型物的方法
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
CN113382714A (zh) * 2019-01-06 2021-09-10 恩多全球美学有限公司 胶原酶制剂及其制备方法
JP7542543B2 (ja) 2019-01-31 2024-08-30 サノフィ・バイオテクノロジー 若年性特発性関節炎を治療するための抗ｉｌ－６受容体抗体
SG11202108627SA (en) 2019-02-18 2021-09-29 Lilly Co Eli Therapeutic antibody formulation
CN114651010A (zh) 2019-04-24 2022-06-21 赛诺菲生物技术公司 类风湿性关节炎的诊断和治疗方法
KR20230061198A (ko) 2019-06-04 2023-05-08 사노피 바이오테크놀로지 류마티스성 관절염을 갖는 대상체에서 통증을 치료하기 위한 조성물 및 방법
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
GB202102258D0 (en) * 2021-02-17 2021-03-31 Arecor Ltd Novel composition
CN116867481A (zh) * 2021-02-17 2023-10-10 艾瑞克有限公司 包含Fc结构域的工程化蛋白质构建体的水性组合物
CA3213505A1 (en) * 2021-03-16 2022-09-22 Kashiv Biosciences, Llc Novel formulation of fusion protein

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
CA2226575C (en) * 1995-07-27 2011-10-18 Genentech, Inc. Stabile 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
CA2634663C (en) * 1999-02-22 2009-08-25 University Of Connecticut Novel albumin-free factor viii formulations
EP1174148A4 (en) * 1999-04-28 2005-05-04 Yamanouchi Pharma Co Ltd PARENTAL MEDICAL COMPOSITIONS CONTAINING FRAGMENTS OF HUMANIZED MONOCLONAL ANTIBODIES AND METHOD FOR STABILIZING THE SAME
SI1478394T1 (sl) * 2002-02-27 2008-12-31 Immunex Corp STABILIZIRAN TNFR-Fc SESTAVEK Z ARGININOM
AU2005225000A1 (en) * 2004-03-04 2005-09-29 Wyeth Lyophilization method to improve excipient crystallization

Also Published As

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

Similar Documents

Publication Publication Date Title
CR10012A (es) Formulaciones de proteina de fusión de Inmunoglobulina
ES2535084T3 (es) Proteínas N-glicosiladas recombinantes procedentes de células procariotas
PT2459167E (pt) Formulação subcutânea de anticorpo anti-her2
PE20090738A1 (es) Formulaciones de anticuerpos
AR072058A1 (es) Composicion detergente que comprende una variante de la familia 44 de xiloglucanasas
IL184845A0 (en) Chimeric recombinant antigens of toxoplasma gondii
MX2012006831A (es) Formacion de anticuerpos.
ECSP077246A (es) Formulaciones Estabilizadoras
CY1117727T1 (el) Φαρμακευτικες συνθεσεις κλωστηριδιακης τοξινης σταθεροποιημενης χωρις πρωτεϊνη
MX2009006594A (es) Formulaciones de ph regulado y estables que contienen polipeptidos.
EA200802170A1 (ru) Лиофилизированная композиция терапевтического пептидного антитела
MX2010010726A (es) Composicion de estilizado de cabello.
EA200702576A1 (ru) Иммуногенная композиция
MX360432B (es) Formulaciones farmaceuticas muy concentradas.
TW200700092A (en) Tigecycline compositions and methods of preparation
AR066782A1 (es) Proceso para proporcionar un relajante muscular estable a la temperatura a base del componente neurotoxico de la oxina botulinica en forma solida
WO2009137778A3 (en) Methods and compositions for genetically engineering clostridia species
PH12022552132A1 (en) Formulations of human anti-tslp antibodies and methods of using the same
MX2021011530A (es) Composicion farmaceutica que contiene anticuerpos contra il-5 y su uso.
BRPI0613362A8 (pt) polipeptídeo quimérico, polinucleotídeo, vetor viral, recombinante do sarampo, uso de um vetor viral, anticorpos, vetor, composição imunogênica e método de prevenção e/ou de tratamento de uma infecção
WO2006105441A3 (en) Fiber constructs comprising bioactive materials and process of fiber fabrication
BR112022022620A2 (pt) Formulações de anticorpos anti-il-33
UA97359C2 (en) Immunogenic composition
WO2006079722A3 (fr) Compositions pour la lyophilisation de proteines
AR037304A1 (es) Composiciones liofilizadas de anticuerpos monoclonales