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 [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], 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 [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2896—Immunoglobulins [IGs], 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 [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [IGs], 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 .
EP1909831A4 (en) 2005-06-14 2013-02-20 Amgen Inc SELF-BUFFING PROTEIN FORMULATIONS
GEP20125628B (en) * 2006-04-21 2012-09-10 Novartis Ag Pharmaceutical compositions containing antagonist anti-cd40 antibody
AU2007240732B2 (en) * 2006-04-21 2013-07-04 Amgen, Inc. Buffering agents for biopharmaceutical formulations
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
EP2527364A1 (en) * 2007-03-29 2012-11-28 Abbott Laboratories Crystalline anti-human IL-12 antibodies
TWI661833B (zh) * 2007-11-30 2019-06-11 百慕達商艾伯維生物技術有限責任公司 蛋白質調配物及製造其之方法
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same
CN104398471A (zh) * 2008-11-28 2015-03-11 Abbvie公司 稳定的抗体组合物和用于稳定其的方法
US9265834B2 (en) 2009-03-05 2016-02-23 Ablynx N.V. Stable formulations of polypeptides and uses thereof
US10005830B2 (en) 2009-03-05 2018-06-26 Ablynx N.V. Antigen binding dimer-complexes, methods of making/avoiding and uses thereof
NZ613809A (en) * 2009-05-04 2015-02-27 Abbvie Biotechnology Ltd Stable high protein concentration formulations of human anti-tnf-alpha-antibodies
PT2473528E (pt) 2009-09-03 2015-03-04 Ablynx NV Formulações estáveis de polipéptidos e seus usos
WO2013006454A1 (en) 2011-07-01 2013-01-10 Biogen Idec Ma Inc. Arginine - free tnfr : fc- fusion polypeptide compositions and methods of use
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
CA3204402A1 (en) * 2012-03-26 2013-10-03 Sanofi Stable anti-cxcr5 igg4 antibody formulations
US9592289B2 (en) 2012-03-26 2017-03-14 Sanofi Stable IgG4 based binding agent formulations
US8883979B2 (en) 2012-08-31 2014-11-11 Bayer Healthcare Llc Anti-prolactin receptor antibody formulations
US9844594B2 (en) * 2012-12-18 2017-12-19 Merck Sharp & Dohme Corp. Liquid formulations for an anti-TNF α antibody
EP3065780A1 (en) 2013-11-04 2016-09-14 Pfizer Inc. Anti-efna4 antibody-drug conjugates
PT3122426T (pt) 2014-03-28 2023-02-28 Univ Duke Tratamento de cancro da mama utilizando moduladores seletivos do recetor de estrogénio
GB201412658D0 (en) 2014-07-16 2014-08-27 Ucb Biopharma Sprl Molecules
JP6629831B2 (ja) * 2014-07-21 2020-01-15 アンチェインド ラブス Δｇ値の濃度依存性に基づくタンパク質凝集の定量
EP3288383A4 (en) 2015-04-29 2019-01-23 Radius Pharmaceuticals, Inc. METHOD FOR THE TREATMENT OF CANCER
GB201601075D0 (en) 2016-01-20 2016-03-02 Ucb Biopharma Sprl Antibodies molecules
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
SG11201900895QA (en) 2016-08-18 2019-02-27 Regeneron Pharma Assay for determining potential to self-association of a protein using concentration-dependent self-interaction nanoparticle spectroscopy
AU2017345490B2 (en) 2016-10-21 2022-07-07 Amgen Inc. Pharmaceutical formulations and methods of making the same
ES2981967T3 (es) 2017-01-05 2024-10-14 Radius Pharmaceuticals Inc Formas polimórficas de RAD1901-2HCl
JP7473486B2 (ja) 2018-07-04 2024-04-23 ラジウス ファーマシューティカルズ，インコーポレイテッド Ｒａｄ１９０１－２ｈｃｌの多形形態
JOP20210218A1 (ar) 2019-02-12 2023-01-30 Radius Pharmaceuticals Inc عمليات ومركبات
US20230167153A1 (en) * 2020-05-01 2023-06-01 Kashiv Biosciences, Llc An improved process of purification of protein
JP2024503462A (ja) * 2021-01-14 2024-01-25 ハノル バイオファーマ カンパニーリミテッド 安定化剤を使用せずに安定した、タンパーナセプトを含む眼科用組成物
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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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
DK0999853T3 (da) 1997-06-13 2003-04-22 Genentech Inc Stabiliseret antostofformulering
AU2444899A (en) 1998-01-22 1999-08-09 Astrazeneca Ab Pharmaceutical formulation comprising an antibody and a citrate buffer
EP1254666A4 (en) * 1999-12-28 2004-12-22 Chugai Pharmaceutical Co Ltd STABLE ANTIBODY COMPOSITIONS AND INJECTION FORMULATIONS
WO2002013860A1 (en) 2000-08-11 2002-02-21 Chugai Seiyaku Kabushiki Kaisha Stabilized antibody-containing preparations
IL155002A0 (en) * 2000-10-12 2003-10-31 Genentech Inc Reduced-viscosity concentrated protein formulations
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TWI438010B (zh) * 2002-05-02 2014-05-21 Wyeth Corp 卡奇黴素（ｃａｌｉｃｈｅａｍｉｃｉｎ）衍生物-載體共軛物
CN1671741A (zh) 2002-06-21 2005-09-21 拜奥根Idec公司 浓缩抗体的缓冲剂制剂及其使用方法
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Also Published As

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

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