CA2681743A1 - Stable antibody formulations - Google Patents

Stable antibody formulations Download PDF

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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)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (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)
  • Biochemistry (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Hematology (AREA)
  • Dermatology (AREA)
  • Oncology (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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US20160355591A1 (en) 2011-05-02 2016-12-08 Immunomedics, Inc. Subcutaneous anti-hla-dr monoclonal antibody for treatment of hematologic malignancies
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
KR20110079693A (ko) 2008-10-29 2011-07-07 와이어쓰 엘엘씨 단일 도메인 항원 결합 분자의 정제 방법
EP2362767B1 (en) * 2008-10-29 2017-12-06 Ablynx N.V. Formulations of single domain antigen binding molecules
BRPI0921845A2 (pt) * 2008-11-12 2019-09-17 Medimmune Llc formulação aquosa estéril estável, forma de dosagem unitária farmacêutica, seringa pré-carregada, e, métodos para tratar uma doença ou distúrbio, para tratar ou prevenir rejeição, para esgotar células t que expressam icos em um paciente humano, e para interromper arquitetura central germinal em um órgão linfóide secundário de um primata
EP2196476A1 (en) * 2008-12-10 2010-06-16 Novartis Ag Antibody formulation
AR074726A1 (es) 2008-12-12 2011-02-09 Boehringer Ingelheim Int Anticuerpos anti-igf (factor de crecimiento insulinico)
TWI505838B (zh) 2010-01-20 2015-11-01 中外製藥股份有限公司 Stabilized antibody solution containing
WO2012028683A1 (en) 2010-09-02 2012-03-08 Novartis Ag Antibody gel system for sustained drug delivery
US8795658B2 (en) * 2010-09-17 2014-08-05 Baxter International Inc. Stabilization of immunoglobulins through aqueous formulation with histidine at weak acidic to neutral pH
BR112013011176A2 (pt) 2010-11-05 2020-09-01 Novartis Ag métodos de tratamento de artrite reumatoide usando antagonistas de il-17
CN103501825B (zh) 2011-05-02 2017-03-15 免疫医疗公司 用于小体积施用的同种异型选择的抗体的超滤浓缩
SG11201401739YA (en) * 2011-10-26 2014-05-29 Amgen Inc Methods of reducing or eliminating protein modification and degradation arising from exposure to uv light
HUE037811T2 (hu) 2011-10-28 2018-09-28 Prothena Biosciences Ltd Alfa-szinukleint felismerõ humanizált antitestek
CN108517010A (zh) 2012-01-27 2018-09-11 普罗典娜生物科学有限公司 识别α-突触核蛋白的人源化抗体
AR094821A1 (es) * 2012-07-25 2015-09-02 Hanmi Pharm Ind Co Ltd Formulación líquida de un conjugado de péptido insulinotrópico de acción prolongada
AR091902A1 (es) * 2012-07-25 2015-03-11 Hanmi Pharm Ind Co Ltd Formulacion liquida de un conjugado de insulina de accion prolongada
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
UA118441C2 (uk) 2012-10-08 2019-01-25 Протена Біосаєнсиз Лімітед Антитіло, що розпізнає альфа-синуклеїн
MX2015006997A (es) 2012-12-26 2015-09-23 Wockhardt Ltd Composicion farmaceutica.
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
CA2944402A1 (en) 2014-04-08 2015-10-15 Prothena Biosciences Limited Blood-brain barrier shuttles containing antibodies recognizing alpha-synuclein
JP6802791B2 (ja) 2014-12-04 2020-12-23 ヤンセン バイオテツク，インコーポレーテツド 急性骨髄性白血病の治療のための抗ｃｄ３８抗体
SG11201705484WA (en) * 2015-02-09 2017-08-30 Ucb Biopharma Sprl Pharmaceutical formulation
BR112017024877A2 (pt) 2015-05-20 2019-09-17 Janssen Biotech, Inc. anticorpo anti-cd38 e seu uso no tratamento de amiloidose de cadeia leve e outras malignidades hematológicas positivas para cd38
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
MD3827845T2 (ro) 2015-11-03 2022-09-30 Janssen Biotech Inc Formulări subcutanate de anticorpi anti-CD38 și utilizări ale acestora
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
US10799597B2 (en) 2017-04-03 2020-10-13 Immunomedics, Inc. Subcutaneous administration of antibody-drug conjugates for cancer therapy
MA50514A (fr) 2017-10-31 2020-09-09 Janssen Biotech Inc Méthodes de traitement du myélome multiple à haut risque
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
CN115697404A (zh) 2020-05-29 2023-02-03 中外制药株式会社 含有抗体的制剂
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
JP2010522208A (ja) 2010-07-01
UA96473C2 (ru) 2011-11-10
BRPI0809112A2 (pt) 2014-08-26
US20100260766A1 (en) 2010-10-14
IL200321A0 (en) 2010-04-29
ECSP099642A (es) 2009-11-30
EP2136839A2 (en) 2009-12-30
EA200970880A1 (ru) 2010-02-26
KR20090113340A (ko) 2009-10-29
ZA200905636B (en) 2010-10-27
CN101668540A (zh) 2010-03-10
TN2009000382A1 (en) 2010-12-31
DOP2009000222A (es) 2009-12-15
AU2008228823A1 (en) 2008-09-25
CR11005A (es) 2010-08-05
MX2009010179A (es) 2010-03-15
WO2008116103A2 (en) 2008-09-25
EP2136839A4 (en) 2010-04-07
WO2008116103A3 (en) 2009-01-08

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Legal Events

Date Code Title Description
EEER Examination request
FZDE Discontinued

Effective date: 20130320