ES2637854T3 - Formulaciones estabilizadoras - Google Patents

Formulaciones estabilizadoras Download PDF

Info

Publication number
ES2637854T3
ES2637854T3 ES05803522.1T ES05803522T ES2637854T3 ES 2637854 T3 ES2637854 T3 ES 2637854T3 ES 05803522 T ES05803522 T ES 05803522T ES 2637854 T3 ES2637854 T3 ES 2637854T3
Authority
ES
Spain
Prior art keywords
formulation
protein
antibody
percentage
molecular weight
Prior art date
Legal status (The legal status 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 status listed.)
Expired - Lifetime
Application number
ES05803522.1T
Other languages
English (en)
Spanish (es)
Inventor
Li Li
Angela Kantor
Shannon B Macmillan
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Wyeth LLC
Original Assignee
Wyeth LLC
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 LLC filed Critical Wyeth LLC
Application granted granted Critical
Publication of ES2637854T3 publication Critical patent/ES2637854T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2896—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Cell Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
ES05803522.1T 2004-08-13 2005-08-12 Formulaciones estabilizadoras Expired - Lifetime ES2637854T3 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US60131104P 2004-08-13 2004-08-13
US601311P 2004-08-13
PCT/US2005/028861 WO2006020935A2 (en) 2004-08-13 2005-08-12 Stabilizing formulations

Publications (1)

Publication Number Publication Date
ES2637854T3 true ES2637854T3 (es) 2017-10-17

Family

ID=35908214

Family Applications (1)

Application Number Title Priority Date Filing Date
ES05803522.1T Expired - Lifetime ES2637854T3 (es) 2004-08-13 2005-08-12 Formulaciones estabilizadoras

Country Status (18)

Country Link
US (1) US8871201B2 (enExample)
EP (1) EP1784219B1 (enExample)
JP (1) JP4948407B2 (enExample)
KR (1) KR20070092197A (enExample)
CN (1) CN101022831A (enExample)
AR (1) AR051009A1 (enExample)
AU (1) AU2005272603A1 (enExample)
BR (1) BRPI0514340A (enExample)
CA (1) CA2575870A1 (enExample)
CR (1) CR8904A (enExample)
EC (1) ECSP077246A (enExample)
ES (1) ES2637854T3 (enExample)
IL (1) IL181265A0 (enExample)
MX (1) MX2007001599A (enExample)
NO (1) NO20070930L (enExample)
RU (1) RU2007109062A (enExample)
TW (1) TW200621282A (enExample)
WO (1) WO2006020935A2 (enExample)

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JO3000B1 (ar) 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
WO2006138181A2 (en) 2005-06-14 2006-12-28 Amgen Inc. Self-buffering protein formulations
GEP20125628B (en) * 2006-04-21 2012-09-10 Novartis Ag Pharmaceutical compositions containing antagonist anti-cd40 antibody
JP2009534390A (ja) * 2006-04-21 2009-09-24 アムジェン インコーポレイテッド 生物医薬品製剤のための緩衝剤
US20080070230A1 (en) * 2006-06-12 2008-03-20 Wyeth Methods for reducing or preventing liquid-liquid phase separation in high concentration protein solutions
EP1950225A1 (de) * 2007-01-25 2008-07-30 Octapharma AG Verfahren zur Steigerung von Proteinausbeuten
NZ598881A (en) * 2007-03-29 2013-11-29 Abbvie Inc Crystalline anti-human il-12 antibodies
KR20210049186A (ko) * 2007-11-30 2021-05-04 애브비 바이오테크놀로지 리미티드 단백질 제형 및 이의 제조방법
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same
MX2011005672A (es) * 2008-11-28 2011-06-20 Abbott Lab Composiciones de anticuerpo estables y metodos para estabilizar a las mismas.
WO2010100135A1 (en) 2009-03-05 2010-09-10 Ablynx N.V. Novel antigen binding dimer-complexes, methods of making/avoiding and uses thereof
US9265834B2 (en) 2009-03-05 2016-02-23 Ablynx N.V. Stable formulations of polypeptides and uses thereof
NZ595694A (en) * 2009-05-04 2013-09-27 Abbvie Biotechnology Ltd Stable high protein concentration formulations of human anti-tnf-alpha-antibodies
LT2805731T (lt) 2009-09-03 2019-02-11 Ablynx N.V. Stabilios polipeptidų kompozicijos ir jų panaudojimas
MX421100B (es) 2011-07-01 2025-02-10 Biogen Ma Inc Composiciones del polipeptido de fusion tnfr: fc exentas de arginina y metodos de uso
AU2012345768B2 (en) 2011-11-30 2016-05-12 Kindeva Drug Delivery L.P. Microneedle device having a peptide therapeutic agent and an amino acid, methods of making and using the same
US9592289B2 (en) 2012-03-26 2017-03-14 Sanofi Stable IgG4 based binding agent formulations
EP4527855A3 (en) * 2012-03-26 2025-06-11 Sanofi Stable igg4 based binding agent formulations
US8883979B2 (en) 2012-08-31 2014-11-11 Bayer Healthcare Llc Anti-prolactin receptor antibody formulations
EP2934587A4 (en) * 2012-12-18 2016-08-03 Merck Sharp & Dohme Liquid formulations for an anti-TNF-alpha-antibody
BR112016010051A2 (pt) 2013-11-04 2017-12-05 Pfizer ?conjugados de anticorpo-fármaco anti-efna4?
RS67458B1 (sr) 2014-03-28 2025-12-31 Univ Duke Lečenje kancera dojke pozitivnog na receptor estrogena upotrebom selektivnih modulatora receptora estrogena
GB201412658D0 (en) 2014-07-16 2014-08-27 Ucb Biopharma Sprl Molecules
WO2016014546A1 (en) * 2014-07-21 2016-01-28 Unchained Labs Inc. Determination of protein aggregation from the concentration dependence of delta g
KR102676629B1 (ko) 2015-04-29 2024-06-18 래디어스 파마슈티컬스, 인코포레이티드 암을 치료하는 방법
GB201601077D0 (en) 2016-01-20 2016-03-02 Ucb Biopharma Sprl Antibody molecule
GB201601073D0 (en) 2016-01-20 2016-03-02 Ucb Biopharma Sprl Antibodies
GB201601075D0 (en) 2016-01-20 2016-03-02 Ucb Biopharma Sprl Antibodies molecules
IL264640B2 (en) 2016-08-18 2024-03-01 Regeneron Pharma Assay for determining potential to self-association of a protein using concentration-dependent self-interaction nanoparticle spectroscopy
ES3064802T3 (en) 2016-10-21 2026-04-29 Amgen Inc Pharmaceutical formulations and methods of making the same
KR102881465B1 (ko) 2017-01-05 2025-11-04 래디어스 파마슈티컬스, 인코포레이티드 Rad1901-2hcl의 다형 형태
CN112423844B (zh) 2018-07-04 2024-08-13 雷迪厄斯制药公司 Rad1901-2hcl的多晶型形式
JOP20210218A1 (ar) 2019-02-12 2023-01-30 Radius Pharmaceuticals Inc عمليات ومركبات
AU2021262609A1 (en) * 2020-05-01 2022-12-22 Kashiv Biosciences, Llc An improved process of purification of protein
US20240059768A1 (en) * 2021-01-14 2024-02-22 Hanall Biopharma Co., Ltd. A stable ophthalmic composition comprising tanfanercept, which is free of stabilizer or substantially free of stabilizer
CN115541895B (zh) * 2022-11-29 2023-05-19 天津德祥生物技术股份有限公司 一种提高微流控反定检测卡灵敏度的配方液及应用

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US5869053A (en) * 1988-03-04 1999-02-09 Cancer Research Campaign Technology, Ltd. 5T4 antigen from human trophoblasts
US6267958B1 (en) * 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
EP0852951A1 (de) 1996-11-19 1998-07-15 Roche Diagnostics GmbH Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern
US6306393B1 (en) * 1997-03-24 2001-10-23 Immunomedics, Inc. Immunotherapy of B-cell malignancies using anti-CD22 antibodies
AU747602B2 (en) * 1997-06-04 2002-05-16 Oxford Biomedica (Uk) Limited Vector
EP0999853B1 (en) 1997-06-13 2003-01-02 Genentech, Inc. Stabilized antibody formulation
WO1999037329A1 (en) 1998-01-22 1999-07-29 Astrazeneca Ab Pharmaceutical formulation comprising an antibody and a citrate buffer
JP4516711B2 (ja) * 1999-12-28 2010-08-04 中外製薬株式会社 安定な抗体組成物及び注射製剤
JP5485489B2 (ja) 2000-08-11 2014-05-07 中外製薬株式会社 抗体含有安定化製剤
JP4340062B2 (ja) * 2000-10-12 2009-10-07 ジェネンテック・インコーポレーテッド 粘度の減少した濃縮タンパク質製剤
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EP1551875A4 (en) * 2002-06-21 2006-06-28 Biogen Idec Inc TAMPON PREPARATIONS FOR CONCENTRATING ANTIBODIES AND METHODS FOR USE THEREOF
US20040033228A1 (en) 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
JP2007528868A (ja) * 2003-08-14 2007-10-18 ワイス 抗ルイスｙ抗イディオタイプ抗体およびその使用
US20060088522A1 (en) * 2004-09-10 2006-04-27 Wyeth Humanized anti-5T4 antibodies and anti-5T4/calicheamicin conjugates

Also Published As

Publication number Publication date
EP1784219B1 (en) 2017-05-17
JP2008515775A (ja) 2008-05-15
CR8904A (es) 2007-08-28
AR051009A1 (es) 2006-12-13
TW200621282A (en) 2006-07-01
US8871201B2 (en) 2014-10-28
AU2005272603A1 (en) 2006-02-23
MX2007001599A (es) 2007-04-10
ECSP077246A (es) 2007-05-30
JP4948407B2 (ja) 2012-06-06
US20060115472A1 (en) 2006-06-01
RU2007109062A (ru) 2008-09-20
BRPI0514340A (pt) 2008-06-10
CA2575870A1 (en) 2006-02-23
EP1784219A2 (en) 2007-05-16
KR20070092197A (ko) 2007-09-12
WO2006020935A2 (en) 2006-02-23
WO2006020935A3 (en) 2007-03-08
IL181265A0 (en) 2007-07-04
EP1784219A4 (en) 2010-02-17
CN101022831A (zh) 2007-08-22
NO20070930L (no) 2007-05-14

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