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 .
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

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
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
GB0113179D0 (en) * 2001-05-31 2001-07-25 Novartis Ag Organic compounds
US20050031627A1 (en) * 2002-01-03 2005-02-10 Mazzola Gregory J Methods for preparing immunoconjugates
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
US20040033228A1 (en) 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
CN1867587A (zh) 2003-08-14 2006-11-22 惠氏公司 抗Lewis Y抗独特型抗体及其用途
TW200616662A (en) * 2004-09-10 2006-06-01 Wyeth Corp Humanized anti-5t4 antibodies and anti-5t4 antibody/calicheamicin conjugates

Also Published As

Publication number Publication date
EP1784219A4 (en) 2010-02-17
ES2637854T3 (es) 2017-10-17
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
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

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
EP3686217A1 (en) Low concentration antibody formulations
KR20180100439A (ko) 이중특이적 항체 작제물을 포함하는 약제학적 조성물
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
TWI825297B (zh) 抗Her2 抗體藥物偶聯物藥物製劑
JP2023506629A (ja) 安定した抗pd-1抗体の薬剤学的製剤
JP2023512961A (ja) 安定した抗pd-1抗体薬剤学的製剤
CN114786719A (zh) 抗-连接蛋白抗体制剂
JP2021522209A (ja) ヒト抗pd−l1抗体の配合物
JP7560038B2 (ja) 抗体製剤
US10881709B2 (en) Immune system modulators and compositions
Taschner et al. Modulation of antigenicity related to changes in antibody flexibility upon lyophilization
WO2022117795A1 (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
AU2022420007A1 (en) Complement factor-i formulations
CN117323430A (zh) 抗pcsk9抗体的制剂及其应用
HK40083796A (en) Antibody formulation
CN118076381A (zh) 改进免疫检查点抑制剂的稳定性的方法
HK1248574B (en) Immune system modulators and compositions

Legal Events

Date Code Title Description
EEER Examination request
FZDE Discontinued

Effective date: 20180313