CA2681743A1 - Stable antibody formulations - Google Patents

Stable antibody formulations Download PDF

Info

Publication number
CA2681743A1
CA2681743A1 CA002681743A CA2681743A CA2681743A1 CA 2681743 A1 CA2681743 A1 CA 2681743A1 CA 002681743 A CA002681743 A CA 002681743A CA 2681743 A CA2681743 A CA 2681743A CA 2681743 A1 CA2681743 A1 CA 2681743A1
Authority
CA
Canada
Prior art keywords
imc
formulation
concentration
liquid formulation
formulations
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
CA002681743A
Other languages
English (en)
French (fr)
Inventor
Arvind Srivastava
Joel Goldstein
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.)
ImClone 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 CA2681743A1 publication Critical patent/CA2681743A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • 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
    • A61K9/08—Solutions
    • 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
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • 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
    • C07K16/2863—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Mycology (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Oncology (AREA)
  • Dermatology (AREA)
  • Hematology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
CA002681743A 2007-03-22 2008-03-20 Stable antibody formulations Abandoned CA2681743A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US91974407P 2007-03-22 2007-03-22
US60/919,744 2007-03-22
PCT/US2008/057718 WO2008116103A2 (en) 2007-03-22 2008-03-20 Stable antibody formulations

Publications (1)

Publication Number Publication Date
CA2681743A1 true CA2681743A1 (en) 2008-09-25

Family

ID=39766776

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002681743A Abandoned CA2681743A1 (en) 2007-03-22 2008-03-20 Stable antibody formulations

Country Status (18)

Country Link
US (1) US20100260766A1 (enExample)
EP (1) EP2136839A4 (enExample)
JP (1) JP2010522208A (enExample)
KR (1) KR20090113340A (enExample)
CN (1) CN101668540A (enExample)
AU (1) AU2008228823A1 (enExample)
BR (1) BRPI0809112A2 (enExample)
CA (1) CA2681743A1 (enExample)
CR (1) CR11005A (enExample)
DO (1) DOP2009000222A (enExample)
EA (1) EA200970880A1 (enExample)
EC (1) ECSP099642A (enExample)
IL (1) IL200321A0 (enExample)
MX (1) MX2009010179A (enExample)
TN (1) TN2009000382A1 (enExample)
UA (1) UA96473C2 (enExample)
WO (1) WO2008116103A2 (enExample)
ZA (1) ZA200905636B (enExample)

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TW200838559A (en) * 2006-11-29 2008-10-01 Imclone Systems Inc Insulin-like growth factor-1 receptor antagonists for modulation of weight and liposity
PE20090368A1 (es) 2007-06-19 2009-04-28 Boehringer Ingelheim Int Anticuerpos anti-igf
CA2739352C (en) 2008-10-29 2021-07-13 Wyeth Llc Methods for purification of single domain antigen binding molecules
KR101593285B1 (ko) * 2008-10-29 2016-02-11 아블린쓰 엔.브이. 단일 도메인 항원 결합 분자의 제형
JP5933975B2 (ja) * 2008-11-12 2016-06-15 メディミューン，エルエルシー 抗体製剤
EP2196476A1 (en) * 2008-12-10 2010-06-16 Novartis Ag Antibody formulation
EP2376116B1 (en) 2008-12-12 2015-12-09 Boehringer Ingelheim International GmbH Anti-igf antibodies
AR080428A1 (es) 2010-01-20 2012-04-11 Chugai Pharmaceutical Co Ltd Formulaciones liquidas estabilizadas contentivas de anticuerpos
WO2012028683A1 (en) 2010-09-02 2012-03-08 Novartis Ag Antibody gel system for sustained drug delivery
EA032336B1 (ru) * 2010-09-17 2019-05-31 Баксалта Инкорпорейтид Стабильная водная иммуноглобулиновая композиция и способ стабилизации иммуноглобулиновой композиции
TWI616204B (zh) 2010-11-05 2018-03-01 諾華公司 Ｉｌ-１７抗體用於製備治療牛皮癬性關節炎之藥物之用途
AU2012250924B2 (en) 2011-05-02 2017-05-25 Immunomedics, Inc. Ultrafiltration concentration of allotype selected antibodies for small-volume administration
WO2013063298A1 (en) * 2011-10-26 2013-05-02 Amgen Inc. Methods of reducing or eliminating protein modification and degradation arising from exposure to uv light
HRP20230065T1 (hr) 2011-10-28 2023-03-03 Prothena Biosciences Limited Humanizirana protutijela koja prepoznaju alfa-sinuklein
SG11201404321YA (en) 2012-01-27 2014-08-28 Neotope Biosciences Ltd Humanized antibodies that recognize alpha-synuclein
AR092862A1 (es) * 2012-07-25 2015-05-06 Hanmi Pharm Ind Co Ltd Formulacion liquida de insulina de accion prolongada y un peptido insulinotropico y metodo de preparacion
AR091902A1 (es) * 2012-07-25 2015-03-11 Hanmi Pharm Ind Co Ltd Formulacion liquida de un conjugado de insulina de accion prolongada
AR094821A1 (es) * 2012-07-25 2015-09-02 Hanmi Pharm Ind Co Ltd Formulación líquida de un conjugado de péptido insulinotrópico de acción prolongada
UA118441C2 (uk) 2012-10-08 2019-01-25 Протена Біосаєнсиз Лімітед Антитіло, що розпізнає альфа-синуклеїн
BR112015013223A2 (pt) 2012-12-26 2017-07-11 Wockhardt Ltd composição farmacêutica
US20140255413A1 (en) 2013-03-07 2014-09-11 Boehringer Ingelheim International Gmbh Combination therapy for neoplasia treatment
US9700485B2 (en) 2013-04-24 2017-07-11 Corning Incorporated Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients
NL1040254C2 (en) * 2013-05-17 2014-11-24 Ablynx Nv Stable formulations of immunoglobulin single variable domains and uses thereof.
US10513555B2 (en) * 2013-07-04 2019-12-24 Prothena Biosciences Limited Antibody formulations and methods
US9603927B2 (en) 2014-02-28 2017-03-28 Janssen Biotech, Inc. Combination therapies with anti-CD38 antibodies
US9732154B2 (en) 2014-02-28 2017-08-15 Janssen Biotech, Inc. Anti-CD38 antibodies for treatment of acute lymphoblastic leukemia
US10562973B2 (en) 2014-04-08 2020-02-18 Prothena Bioscience Limited Blood-brain barrier shuttles containing antibodies recognizing alpha-synuclein
EA202092609A1 (ru) 2014-12-04 2021-10-29 Янссен Байотек, Инк. Антитела к cd38 для лечения острого миелолейкоза
PT3256154T (pt) * 2015-02-09 2020-01-09 Ucb Biopharma Sprl Composição farmacêutica compreendendo um anticorpo
CA2986594C (en) 2015-05-20 2025-06-10 Tufts Medical Center, Inc. Anti-CD38 antibodies for the treatment of light chain amyloidosis and other CD38-positive hematological malignancies
AR104847A1 (es) * 2015-06-17 2017-08-16 Lilly Co Eli Formulación de anticuerpo anti-cgrp
US20170044265A1 (en) 2015-06-24 2017-02-16 Janssen Biotech, Inc. Immune Modulation and Treatment of Solid Tumors with Antibodies that Specifically Bind CD38
HUE053366T2 (hu) * 2015-11-03 2021-06-28 Janssen Biotech Inc Szubkután anti-CD38-ellenanyag-készítmények és alkalmazásuk
JP6992262B2 (ja) * 2016-03-31 2022-02-15 東ソー株式会社 変性抗体測定試薬の製造方法
US20190233533A1 (en) 2016-06-28 2019-08-01 Umc Utrecht Holding B.V. Treatment Of IgE-Mediated Diseases With Antibodies That Specifically Bind CD38
CN110352201A (zh) 2017-04-03 2019-10-18 免疫医疗公司 用于癌症疗法的抗体药物缀合物的皮下施用
CN111565751A (zh) 2017-10-31 2020-08-21 詹森生物科技公司 治疗高危多发性骨髓瘤的方法
SG11202108627SA (en) 2019-02-18 2021-09-29 Lilly Co Eli Therapeutic antibody formulation
CN112206320B (zh) * 2019-07-12 2025-02-25 鲁南制药集团股份有限公司 一种cd47单克隆抗体冻干粉制剂及其制备工艺
TWI872251B (zh) 2020-05-29 2025-02-11 日商中外製藥股份有限公司 含有抗體製劑
CN113967195A (zh) * 2020-07-22 2022-01-25 三生国健药业（上海）股份有限公司 抗her2/pd1双特异性抗体冻干制剂及其制备方法

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Also Published As

Publication number Publication date
TN2009000382A1 (en) 2010-12-31
CR11005A (es) 2010-08-05
EA200970880A1 (ru) 2010-02-26
EP2136839A4 (en) 2010-04-07
CN101668540A (zh) 2010-03-10
BRPI0809112A2 (pt) 2014-08-26
DOP2009000222A (es) 2009-12-15
ZA200905636B (en) 2010-10-27
AU2008228823A1 (en) 2008-09-25
WO2008116103A2 (en) 2008-09-25
ECSP099642A (es) 2009-11-30
JP2010522208A (ja) 2010-07-01
MX2009010179A (es) 2010-03-15
UA96473C2 (ru) 2011-11-10
KR20090113340A (ko) 2009-10-29
IL200321A0 (en) 2010-04-29
EP2136839A2 (en) 2009-12-30
WO2008116103A3 (en) 2009-01-08
US20100260766A1 (en) 2010-10-14

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Legal Events

Date Code Title Description
EEER Examination request
FZDE Discontinued

Effective date: 20130320