DOP2009000222A - Formulaciones estables de anticuerpo - Google Patents

Formulaciones estables de anticuerpo

Info

Publication number
DOP2009000222A
DOP2009000222A DO2009000222A DO2009000222A DOP2009000222A DO P2009000222 A DOP2009000222 A DO P2009000222A DO 2009000222 A DO2009000222 A DO 2009000222A DO 2009000222 A DO2009000222 A DO 2009000222A DO P2009000222 A DOP2009000222 A DO P2009000222A
Authority
DO
Dominican Republic
Prior art keywords
antibody
formulations
insulin
receptor
stabilization
Prior art date
Application number
DO2009000222A
Other languages
English (en)
Inventor
Arvind Srivastava
Joel Goldstein
Original Assignee
Imclone 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 Imclone Llc filed Critical Imclone Llc
Publication of DOP2009000222A publication Critical patent/DOP2009000222A/es

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 [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2863—Immunoglobulins [IGs], 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)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Mycology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Microbiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Hematology (AREA)
  • Oncology (AREA)
  • Dermatology (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)

Abstract

La presente invencion se refiere a formulaciones y metodos para la estabilización de anticuerpos. En una modalidad, la invencion proporciona la formulación de solución estable de un anticuerpo IgG1 que se enlaza especificamente al receptor del factor-I similar a la insulina. En otra modalidad, la invencion proporciona metodos para estabilización de anticuerpo IgGl que se enlazan especificamente al receptor del factor-I de crecimiento similar a la insulina que comprende, liofilizar una formulación acuosa del anticuerpo. Las formulaciones pueden ser liofilizadas para estabilizar los anticuerpos durante el procesamiento y almacenaje, y despues las formulaciones pueden ser reconstituidas para administración farmaceutica.
DO2009000222A 2007-03-22 2009-09-18 Formulaciones estables de anticuerpo DOP2009000222A (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US91974407P 2007-03-22 2007-03-22

Publications (1)

Publication Number Publication Date
DOP2009000222A true DOP2009000222A (es) 2009-12-15

Family

ID=39766776

Family Applications (1)

Application Number Title Priority Date Filing Date
DO2009000222A DOP2009000222A (es) 2007-03-22 2009-09-18 Formulaciones estables de anticuerpo

Country Status (18)

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

Families Citing this family (35)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160279239A1 (en) 2011-05-02 2016-09-29 Immunomedics, Inc. Subcutaneous administration of anti-cd74 antibody for systemic lupus erythematosus and autoimmune disease
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
AR073997A1 (es) * 2008-10-29 2010-12-15 Wyeth Corp Formulaciones de moleculas de union a antigeno de dominio unico. metodo. kit
KR20110079693A (ko) 2008-10-29 2011-07-07 와이어쓰 엘엘씨 단일 도메인 항원 결합 분자의 정제 방법
WO2010056804A1 (en) * 2008-11-12 2010-05-20 Medimmune, Llc Antibody formulation
EP2196476A1 (en) * 2008-12-10 2010-06-16 Novartis Ag Antibody formulation
PL2376116T3 (pl) 2008-12-12 2016-07-29 Boehringer Ingelheim Int Przeciwciała anty-IGF
TWI609698B (zh) 2010-01-20 2018-01-01 Chugai Pharmaceutical Co Ltd 穩定化的含抗體溶液製劑
WO2012028683A1 (en) 2010-09-02 2012-03-08 Novartis Ag Antibody gel system for sustained drug delivery
CA2810734A1 (en) * 2010-09-17 2012-03-22 Baxter International Inc. Stabilization of immunoglobulins through aqueous formulation with histidine at weak acidic to neutral ph
LT3111954T (lt) 2010-11-05 2019-07-10 Novartis Ag Ankilozuojančio spondilito gydymo būdai, naudojant anti-il-17 antikūnus
WO2012151199A1 (en) 2011-05-02 2012-11-08 Immunomedics, Inc. Ultrafiltration concentration of allotype selected antibodies for small-volume administration
EA034347B1 (ru) * 2011-10-26 2020-01-30 Амген Инк. Способ инактивации вирусов при получении антител
HUE037811T2 (hu) 2011-10-28 2018-09-28 Prothena Biosciences Ltd Alfa-szinukleint felismerõ humanizált antitestek
WO2013112945A1 (en) 2012-01-27 2013-08-01 Neotope Biosciences Limited Humanized antibodies that recognize alpha-synuclein
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
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
AU2013368990B2 (en) 2012-12-26 2017-05-18 Wockhardt Limited Pharmaceutical composition
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
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
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
RS63210B1 (sr) 2015-11-03 2022-06-30 Janssen Biotech Inc Potkožne formulacije anti-cd38 antitela i njihova upotreba
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
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
JP2021502961A (ja) 2017-10-31 2021-02-04 ヤンセン バイオテツク，インコーポレーテツド 高リスク多発性骨髄腫の治療方法
US11634485B2 (en) 2019-02-18 2023-04-25 Eli Lilly And Company Therapeutic antibody formulation

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0565233A (ja) * 1991-03-08 1993-03-19 Mitsui Toatsu Chem Inc モノクローナル抗体含有凍結乾燥製剤
DK0590058T3 (da) * 1991-06-14 2004-03-29 Genentech Inc Humaniseret heregulin-antistof
US6267958B1 (en) * 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
EP1324776B2 (en) * 2000-10-12 2018-03-21 Genentech, Inc. Reduced-viscosity concentrated protein formulations
DK2270052T3 (en) * 2001-06-26 2018-07-02 Amgen Inc Antibodies to OPGL
CA2454587C (en) * 2001-07-25 2012-11-13 Protein Design Labs, Inc. Stable lyophilized pharmaceutical formulation of igg antibodies
KR20040085185A (ko) * 2002-02-14 2004-10-07 추가이 세이야쿠 가부시키가이샤 항체함유 용액제제
KR20050109489A (ko) * 2003-02-13 2005-11-21 화이자 프로덕츠 인크. 항-인슐린양 성장인자 ｉ 수용체 항체의 용도
CA2524305C (en) * 2003-05-01 2015-12-08 Imclone Systems Incorporated Fully human antibodies directed against the human insulin-like growth factor-1 receptor
AR046071A1 (es) * 2003-07-10 2005-11-23 Hoffmann La Roche Anticuerpos contra el receptor i del factor de crecimiento de tipo insulinico y los usos de los mismos
UA85058C2 (ru) * 2003-08-13 2008-12-25 Пфайзер Продактс Инк. Модифицированное моноклональное антитело человека, которое специфически связывается с рецептором подобного к инсулину фактора роста i человека (igf-ir)
WO2006125207A2 (en) * 2005-05-19 2006-11-23 Amgen Inc. Compositions and methods for increasing the stability of antibodies
NZ564098A (en) * 2005-06-15 2010-04-30 Schering Corp Anti-IGF1R antibody formulations
JP2009531371A (ja) * 2006-03-28 2009-09-03 エフ．ホフマン−ラ ロシュ アーゲー 抗ｉｇｆ−１ｒヒト・モノクローナル抗体製剤

Also Published As

Publication number Publication date
EP2136839A2 (en) 2009-12-30
BRPI0809112A2 (pt) 2014-08-26
KR20090113340A (ko) 2009-10-29
JP2010522208A (ja) 2010-07-01
IL200321A0 (en) 2010-04-29
WO2008116103A2 (en) 2008-09-25
CR11005A (es) 2010-08-05
ECSP099642A (es) 2009-11-30
UA96473C2 (ru) 2011-11-10
WO2008116103A3 (en) 2009-01-08
MX2009010179A (es) 2010-03-15
CA2681743A1 (en) 2008-09-25
US20100260766A1 (en) 2010-10-14
ZA200905636B (en) 2010-10-27
TN2009000382A1 (en) 2010-12-31
CN101668540A (zh) 2010-03-10
AU2008228823A1 (en) 2008-09-25
EA200970880A1 (ru) 2010-02-26
EP2136839A4 (en) 2010-04-07

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