ES2637854T3 - Formulaciones estabilizadoras - Google Patents

Formulaciones estabilizadoras Download PDF

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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)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Cell Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (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 (https=)
EP (1) EP1784219B1 (https=)
JP (1) JP4948407B2 (https=)
KR (1) KR20070092197A (https=)
CN (1) CN101022831A (https=)
AR (1) AR051009A1 (https=)
AU (1) AU2005272603A1 (https=)
BR (1) BRPI0514340A (https=)
CA (1) CA2575870A1 (https=)
CR (1) CR8904A (https=)
EC (1) ECSP077246A (https=)
ES (1) ES2637854T3 (https=)
IL (1) IL181265A0 (https=)
MX (1) MX2007001599A (https=)
NO (1) NO20070930L (https=)
RU (1) RU2007109062A (https=)
TW (1) TW200621282A (https=)
WO (1) WO2006020935A2 (https=)

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BRPI0611901A2 (pt) 2005-06-14 2012-08-28 Amgen, Inc composição, liofilizado, kit, e, processo para preparar uma composição
AU2007240732B2 (en) * 2006-04-21 2013-07-04 Amgen, Inc. Buffering agents for biopharmaceutical formulations
AR060487A1 (es) 2006-04-21 2008-06-18 Xoma Technology Ltd Composiciones farmaceuticas de antagonistas del anticuerpo anti- cd40
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
RU2476442C2 (ru) 2007-03-29 2013-02-27 Эббот Лэборетриз Кристаллические антитела против il-12 человека
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same
US8420081B2 (en) * 2007-11-30 2013-04-16 Abbvie, Inc. Antibody formulations and methods of making same
RU2011126338A (ru) * 2008-11-28 2013-01-10 Эбботт Лэборетриз Стабильные композиции антител и способы их стабилизации
US10005830B2 (en) 2009-03-05 2018-06-26 Ablynx N.V. 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
LT2805731T (lt) 2009-09-03 2019-02-11 Ablynx N.V. Stabilios polipeptidų kompozicijos ir jų panaudojimas
CN103930124B (zh) 2011-07-01 2021-05-11 生物基因Ma公司 无精氨酸的tnfr：fc-融合多肽组合物及使用方法
KR102143482B1 (ko) 2011-11-30 2020-08-11 쓰리엠 이노베이티브 프로퍼티즈 컴파니 펩티드 치료제 및 아미노산을 포함하는 마이크로니들 장치, 이의 제조 및 사용 방법
EP4527855A3 (en) * 2012-03-26 2025-06-11 Sanofi Stable igg4 based binding agent 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
JP2016540826A (ja) 2013-11-04 2016-12-28 ファイザー・インク 抗ｅｆｎａ４抗体−薬物コンジュゲート
ES3055185T3 (en) 2014-03-28 2026-02-10 Univ Duke Treatment of an estrogen receptor positive breast cancer using a selective estrogen receptor modulator
GB201412658D0 (en) 2014-07-16 2014-08-27 Ucb Biopharma Sprl Molecules
EP3194977B1 (en) * 2014-07-21 2019-10-02 Unchained Labs Determination of protein aggregation from the concentration dependence of delta g
KR20250152679A (ko) 2015-04-29 2025-10-23 래디어스 파마슈티컬스, 인코포레이티드 암을 치료하는 방법
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
GB201601077D0 (en) 2016-01-20 2016-03-02 Ucb Biopharma Sprl Antibody molecule
WO2018035470A1 (en) 2016-08-18 2018-02-22 Regeneron Pharmaceuticals, Inc. Assay for determining potential to self-association of a protein using concentration-dependent self-interaction nanoparticle spectroscopy
PT3528787T (pt) 2016-10-21 2026-03-11 Amgen Inc Formulações farmacêuticas e métodos para produzir as mesmas
JP7481115B2 (ja) 2017-01-05 2024-05-10 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の多形性形態
MX2020013713A (es) 2018-07-04 2021-03-02 Radius Pharmaceuticals Inc Formas polimorficas de rad1901-2hcl.
EP3924328A1 (en) 2019-02-12 2021-12-22 Radius Pharmaceuticals, Inc. Processes and compounds
AU2021262609A1 (en) * 2020-05-01 2022-12-22 Kashiv Biosciences, Llc An improved process of purification of protein
KR20230131212A (ko) * 2021-01-14 2023-09-12 한올바이오파마주식회사 안정화제를 사용하지 않고도 안정한, 탄파너셉트를포함하는 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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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
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WO2001047554A1 (fr) * 1999-12-28 2001-07-05 Chugai Seiyaku Kabushiki Kaisha Compositions d'anticorps stables et preparations pour injection
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
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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
AU2005272603A1 (en) 2006-02-23
BRPI0514340A (pt) 2008-06-10
WO2006020935A3 (en) 2007-03-08
WO2006020935A2 (en) 2006-02-23
MX2007001599A (es) 2007-04-10
US8871201B2 (en) 2014-10-28
EP1784219A4 (en) 2010-02-17
EP1784219A2 (en) 2007-05-16
RU2007109062A (ru) 2008-09-20
IL181265A0 (en) 2007-07-04
EP1784219B1 (en) 2017-05-17
NO20070930L (no) 2007-05-14
CR8904A (es) 2007-08-28
CA2575870A1 (en) 2006-02-23
CN101022831A (zh) 2007-08-22
ECSP077246A (es) 2007-05-30
TW200621282A (en) 2006-07-01
JP4948407B2 (ja) 2012-06-06
JP2008515775A (ja) 2008-05-15
KR20070092197A (ko) 2007-09-12
AR051009A1 (es) 2006-12-13
US20060115472A1 (en) 2006-06-01

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