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 .
JP2008543839A (ja) 2005-06-14 2008-12-04 アムジェン インコーポレーテッド 自己緩衝タンパク質製剤
SMP200800064B (it) * 2006-04-21 2009-11-06 Novartis Ag Composizioni farmaceutiche di anticorpi anti-cd40 antagonista
CA2649538C (en) * 2006-04-21 2014-06-03 Yatin Gokarn 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
CA2681752A1 (en) 2007-03-29 2008-10-09 Abbott Laboratories Crystalline anti-human 1l-12 antibodies
US8420081B2 (en) * 2007-11-30 2013-04-16 Abbvie, Inc. Antibody formulations and methods of making same
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.
EP2403873A1 (en) 2009-03-05 2012-01-11 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
US20100278822A1 (en) * 2009-05-04 2010-11-04 Abbott Biotechnology, Ltd. Stable high protein concentration formulations of human anti-tnf-alpha-antibodies
EP2473528B1 (en) 2009-09-03 2014-12-03 Ablynx N.V. Stable formulations of polypeptides and uses thereof
EA026226B1 (ru) * 2011-07-01 2017-03-31 Байоджен Айдек Ма Инк. Не содержащие аргинина композиции слитого fc-полипептида и способы их применения
AU2012345777B2 (en) 2011-11-30 2016-05-12 Kindeva Drug Delivery L.P. Microneedle device including a peptide therapeutic agent and an amino acid and methods of making and using the same
JP6265970B2 (ja) * 2012-03-26 2018-01-24 サノフイ 安定なＩｇＧ４に基づく結合剤の製剤
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
RU2016119491A (ru) 2013-11-04 2017-12-11 Пфайзер Инк. Конъюгаты антитела к efna4 с лекарственным средством
ES2939940T3 (es) 2014-03-28 2023-04-28 Univ Duke Tratamiento del cáncer de mama utilizando moduladores selectivos de los receptores de estrógenos
GB201412658D0 (en) 2014-07-16 2014-08-27 Ucb Biopharma Sprl Molecules
AU2015292822B2 (en) * 2014-07-21 2021-11-25 Unchained Labs Determination of protein aggregation from the concentration dependence of delta G
MX384605B (es) 2015-04-29 2025-03-14 Radius Pharmaceuticals Inc Combinación de palbociclib y rad1901 para usarse en el tratamiento de cáncer de mama en un sujeto con cáncer positivo a receptor de estrógeno.
GB201601075D0 (en) 2016-01-20 2016-03-02 Ucb Biopharma Sprl Antibodies molecules
GB201601073D0 (en) 2016-01-20 2016-03-02 Ucb Biopharma Sprl Antibodies
GB201601077D0 (en) 2016-01-20 2016-03-02 Ucb Biopharma Sprl Antibody molecule
EA201990316A1 (ru) 2016-08-18 2019-07-31 Ридженерон Фармасьютикалз, Инк. Анализ для определения потенциала самоассоциации белка с использованием концентрационно-зависимой спектроскопии самовзаимодействия на основе наночастиц
ES3064802T3 (en) 2016-10-21 2026-04-29 Amgen Inc Pharmaceutical formulations and methods of making the same
EP3565542B1 (en) 2017-01-05 2024-04-10 Radius Pharmaceuticals, Inc. Polymorphic forms of rad1901-2hcl
SG11202013177WA (en) 2018-07-04 2021-01-28 Radius Pharmaceuticals Inc Polymorphic forms of rad 1901-2hcl
US12441745B2 (en) 2019-02-12 2025-10-14 Radius Pharmaceuticals, Inc. Processes and compounds
AU2021262609A1 (en) * 2020-05-01 2022-12-22 Kashiv Biosciences, Llc An improved process of purification of protein
WO2022154529A1 (ko) * 2021-01-14 2022-07-21 한올바이오파마주식회사 안정화제를 사용하지 않고도 안정한, 탄파너셉트를 포함하는 안과용 조성물
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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DE3176517D1 (en) 1980-04-24 1987-12-17 Beecham Group Plc Beta-lactam compounds, their preparation and use
GB8518416D0 (en) 1985-07-22 1985-08-29 Beecham Group Plc Compounds
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
PT1012259E (pt) 1997-06-04 2009-11-06 Oxford Biomedica Ltd Vector dirigido a tumor
ATE230277T1 (de) * 1997-06-13 2003-01-15 Genentech Inc Stabilisierte antikörperformulierung
AU2444899A (en) 1998-01-22 1999-08-09 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
US8632778B2 (en) 2000-08-11 2014-01-21 Chugai Seiyaku Kabushiki Kaisha Stabilized anti-interleukin-6 antibody-containing preparations
DE60139944D1 (de) * 2000-10-12 2009-10-29 Genentech Inc Niederviskose konzentrierte proteinformulierungen
GB0113179D0 (en) * 2001-05-31 2001-07-25 Novartis Ag Organic compounds
NZ533657A (en) * 2002-01-03 2008-01-31 Smithkline Beecham Corp Methods for the preparation of immunoconjugates, in particular maytansinoids conjugated to a monoclonal antibody
BR122019027966B8 (pt) 2002-05-02 2021-07-27 Wyeth Corp conjugado monomérico de derivado de caliqueamicina/anti-corpo anti-cd22 e uso dos mesmos
AU2003251592A1 (en) * 2002-06-21 2004-01-06 Biogen Idec Inc. Buffered formulations for concentrating antibodies and methods of 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
CA2578131A1 (en) 2004-09-10 2006-03-23 Wyeth Humanized anti-5t4 antibodies and anti-5t4 antibody/calicheamicin conjugates

Also Published As

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

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