CA2575870A1 - Stabilizing formulations - Google Patents

Stabilizing formulations Download PDF

Info

Publication number
CA2575870A1
CA2575870A1 CA002575870A CA2575870A CA2575870A1 CA 2575870 A1 CA2575870 A1 CA 2575870A1 CA 002575870 A CA002575870 A CA 002575870A CA 2575870 A CA2575870 A CA 2575870A CA 2575870 A1 CA2575870 A1 CA 2575870A1
Authority
CA
Canada
Prior art keywords
protein
formulation
antibody
molecular weight
stability
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.)
Abandoned
Application number
CA002575870A
Other languages
English (en)
French (fr)
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
Individual
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 Individual filed Critical Individual
Publication of CA2575870A1 publication Critical patent/CA2575870A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886Dragees; 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065Purification, fragmentation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2896Immunoglobulins [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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30Immunoglobulins [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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins 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)
CA002575870A 2004-08-13 2005-08-12 Stabilizing formulations Abandoned CA2575870A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US60131104P 2004-08-13 2004-08-13
US60/601,311 2004-08-13
PCT/US2005/028861 WO2006020935A2 (en) 2004-08-13 2005-08-12 Stabilizing formulations

Publications (1)

Publication Number Publication Date
CA2575870A1 true CA2575870A1 (en) 2006-02-23

Family

ID=35908214

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002575870A Abandoned CA2575870A1 (en) 2004-08-13 2005-08-12 Stabilizing formulations

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)

Families Citing this family (36)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JO3000B1 (ar) 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
EP3673919A1 (en) 2005-06-14 2020-07-01 Amgen Inc. Self-buffering protein formulations
AU2007240732B2 (en) * 2006-04-21 2013-07-04 Amgen, Inc. Buffering agents for biopharmaceutical formulations
KR101317235B1 (ko) * 2006-04-21 2013-10-15 조마 테크놀로지 리미티드 길항제 항-cd40 항체 제약 조성물
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
KR20100014674A (ko) 2007-03-29 2010-02-10 아보트 러보러터리즈 결정성 항-사람 il-12 항체
NZ585702A (en) * 2007-11-30 2013-08-30 Abbott Lab Protein formulations and methods of making same
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same
AU2009319856A1 (en) * 2008-11-28 2010-06-03 Abbvie Inc. Stable antibody compositions and methods for stabilizing same
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
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
CA2840711C (en) * 2011-07-01 2023-10-17 Biogen Idec Ma Inc. Arginine-free tnfr:fc-fusion polypeptide compositions and methods of use
WO2013082427A1 (en) 2011-11-30 2013-06-06 3M Innovative Properties Company Microneedle device including a peptide therapeutic agent and an amino acid and methods of making and using the same
US9592289B2 (en) 2012-03-26 2017-03-14 Sanofi Stable IgG4 based binding agent formulations
EP3431104A1 (en) * 2012-03-26 2019-01-23 Sanofi Stable igg4 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
PT3834824T (pt) 2014-03-28 2025-11-18 Univ Duke Tratamento do cancro da mama positivo para o receptor de estrogénio utilizando um modulador seletivo do recetor de estrogénio
GB201412658D0 (en) 2014-07-16 2014-08-27 Ucb Biopharma Sprl Molecules
CN107076759A (zh) * 2014-07-21 2017-08-18 非链实验室 从δg的浓度依赖性来测定蛋白质聚集
CA2984357A1 (en) 2015-04-29 2016-11-03 Radius Pharmaceuticals, Inc. Methods for treating cancer
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
HUE052805T2 (hu) 2016-08-18 2021-05-28 Regeneron Pharma Fehérje önasszociációs képességének meghatározására szolgáló assay koncentrációfüggõ öninterakciós nanorészecske-spektroszkópia segítségével
WO2018075818A1 (en) 2016-10-21 2018-04-26 Amgen Inc. Pharmaceutical formulations and methods of making the same
MX383786B (es) 2017-01-05 2025-03-14 Radius Pharmaceuticals Inc Formas polimorficas de rad1901-2hcl.
AU2019297421B2 (en) 2018-07-04 2024-08-29 Radius Pharmaceuticals, Inc. Polymorphic forms of RAD 1901-2HCL
MX2021009569A (es) 2019-02-12 2021-09-08 Radius Pharmaceuticals Inc Procesos y compuestos.
EP4142792A4 (en) * 2020-05-01 2024-11-27 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

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
US6852703B1 (en) 1997-06-04 2005-02-08 Oxford Biomedica (Uk) Limited Tumor targeted 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
ES2477996T3 (es) * 2000-08-11 2014-07-18 Chugai Seiyaku Kabushiki Kaisha Preparaciones estabilizadas que contienen un anticuerpo
ATE442862T2 (de) * 2000-10-12 2009-10-15 Genentech Inc Niederviskose konzentrierte proteinformulierungen
GB0113179D0 (en) * 2001-05-31 2001-07-25 Novartis Ag Organic compounds
WO2003057163A2 (en) * 2002-01-03 2003-07-17 Smithkline Beecham Corporation Methods for preparing immunoconjugates
BR122019027966B8 (pt) 2002-05-02 2021-07-27 Wyeth Corp conjugado monomérico de derivado de caliqueamicina/anti-corpo anti-cd22 e uso dos mesmos
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
CA2535804A1 (en) * 2003-08-14 2005-03-03 Wyeth Anti-lewis y anti-idiotypic antibodies and uses thereof
BRPI0515113A (pt) 2004-09-10 2008-07-01 Wyeth Corp anticorpos anti-5t4 humanizados e conjugados de anticorpo anti-5t4/caliqueamicina

Also Published As

Publication number Publication date
IL181265A0 (en) 2007-07-04
TW200621282A (en) 2006-07-01
WO2006020935A2 (en) 2006-02-23
ES2637854T3 (es) 2017-10-17
JP4948407B2 (ja) 2012-06-06
US8871201B2 (en) 2014-10-28
MX2007001599A (es) 2007-04-10
ECSP077246A (es) 2007-05-30
AU2005272603A1 (en) 2006-02-23
KR20070092197A (ko) 2007-09-12
AR051009A1 (es) 2006-12-13
US20060115472A1 (en) 2006-06-01
EP1784219A4 (en) 2010-02-17
EP1784219B1 (en) 2017-05-17
CR8904A (es) 2007-08-28
EP1784219A2 (en) 2007-05-16
BRPI0514340A (pt) 2008-06-10
RU2007109062A (ru) 2008-09-20
JP2008515775A (ja) 2008-05-15
WO2006020935A3 (en) 2007-03-08
NO20070930L (no) 2007-05-14
CN101022831A (zh) 2007-08-22

Similar Documents

Publication Publication Date Title
US8871201B2 (en) Stabilizing formulations
US8921526B2 (en) Mutated anti-TNFα antibodies and methods of their use
RU2731418C2 (ru) Стабильный фармацевтический препарат на основе антитела к pd-1 и его применение в медицине
KR20180100439A (ko) 이중특이적 항체 작제물을 포함하는 약제학적 조성물
TWI825297B (zh) 抗Her2 抗體藥物偶聯物藥物製劑
CN113316458A (zh) 抗lag3抗体和抗pd-1抗体的共制剂
JPWO2005063291A1 (ja) 抗体を含有する安定な水性医薬製剤
JP2023506629A (ja) 安定した抗pd-1抗体の薬剤学的製剤
JP2021522209A (ja) ヒト抗pd−l1抗体の配合物
JP7560038B2 (ja) 抗体製剤
JPWO2008029908A1 (ja) 抗体を含有する安定な凍結乾燥医薬製剤
EP4094777A1 (en) Recombinant fully human anti-tigit monoclonal antibody preparations, preparation method therefor and use thereof
US10881709B2 (en) Immune system modulators and compositions
Taschner et al. Modulation of antigenicity related to changes in antibody flexibility upon lyophilization
EP4255479A1 (en) Novel formulations for antibodies
EP4169530A1 (en) Stable formulation for recombinant anti-pd-1 monoclonal antibody
JP2023553209A (ja) 融合タンパク質の医薬製剤
JP2022531331A (ja) 抗il-6抗体製剤
RU2827610C1 (ru) Стабильная композиция рекомбинантного моноклонального антитела против pd-1
CN117323430A (zh) 抗pcsk9抗体的制剂及其应用
JP2025503483A (ja) 補体因子-i製剤
HK40083796A (en) Antibody formulation
HK1248574B (en) Immune system modulators and compositions
HK1144178B (en) Antibody-containing solution pharmaceuticals

Legal Events

Date Code Title Description
EEER Examination request
FZDE Discontinued

Effective date: 20180313