CN101668540A - 稳定的抗体制剂 - Google Patents

稳定的抗体制剂 Download PDF

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Publication number
CN101668540A
CN101668540A CN200880009446A CN200880009446A CN101668540A CN 101668540 A CN101668540 A CN 101668540A CN 200880009446 A CN200880009446 A CN 200880009446A CN 200880009446 A CN200880009446 A CN 200880009446A CN 101668540 A CN101668540 A CN 101668540A
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CN
China
Prior art keywords
imc
ser
liquid preparation
val
thr
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.)
Pending
Application number
CN200880009446A
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English (en)
Chinese (zh)
Inventor
A·斯里瓦斯塔瓦
J·戈德施泰因
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
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ImClone Systems Inc
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 Systems Inc filed Critical ImClone Systems Inc
Publication of CN101668540A publication Critical patent/CN101668540A/zh
Pending legal-status Critical Current

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    • 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

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  • 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)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Mycology (AREA)
  • Biochemistry (AREA)
  • Microbiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Oil, Petroleum & Natural Gas (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)
CN200880009446A 2007-03-22 2008-03-20 稳定的抗体制剂 Pending CN101668540A (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US91974407P 2007-03-22 2007-03-22
US60/919,744 2007-03-22

Publications (1)

Publication Number Publication Date
CN101668540A true CN101668540A (zh) 2010-03-10

Family

ID=39766776

Family Applications (1)

Application Number Title Priority Date Filing Date
CN200880009446A Pending CN101668540A (zh) 2007-03-22 2008-03-20 稳定的抗体制剂

Country Status (18)

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

Cited By (3)

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Publication number Priority date Publication date Assignee Title
CN104524566A (zh) * 2010-09-17 2015-04-22 巴克斯特国际公司 通过具有组氨酸的水性制剂在弱酸性至中性pH稳定的免疫球蛋白
CN105492019A (zh) * 2013-07-04 2016-04-13 普罗塞纳生物科学有限公司 抗体制剂和方法
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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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
EP2362767B1 (en) 2008-10-29 2017-12-06 Ablynx N.V. Formulations of single domain antigen binding molecules
BRPI0919879A2 (pt) 2008-10-29 2016-02-16 Wyeth Llc métodos para purificação de moléculas de ligação a antígeno de domínio único
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
NZ592151A (en) 2008-12-12 2012-10-26 Boehringer Ingelheim Int 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
MX362591B (es) 2010-11-05 2019-01-25 Novartis Ag Uso de antagonistas de il-17.
AU2012250924B2 (en) 2011-05-02 2017-05-25 Immunomedics, Inc. Ultrafiltration concentration of allotype selected antibodies for small-volume administration
EA201992617A1 (ru) * 2011-10-26 2020-03-10 Амген Инк. Способы уменьшения или устранения модификации и разложения белка, обусловленных воздействием уф-излучения
US8609820B2 (en) 2011-10-28 2013-12-17 Neotope Biosciences Limited Humanized antibodies that recognize alpha-synuclein
NZ629296A (en) 2012-01-27 2016-06-24 Prothena 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
JP2016505601A (ja) 2012-12-26 2016-02-25 ウォックハート リミテッド 医薬組成物
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.
US9732154B2 (en) 2014-02-28 2017-08-15 Janssen Biotech, Inc. Anti-CD38 antibodies for treatment of acute lymphoblastic leukemia
US9603927B2 (en) 2014-02-28 2017-03-28 Janssen Biotech, Inc. Combination therapies with anti-CD38 antibodies
JP6744856B2 (ja) 2014-04-08 2020-08-19 プロセナ・バイオサイエンシズ・リミテッド α−シヌクレインを認識する抗体を含む血液脳関門シャトル
AU2015358615B2 (en) 2014-12-04 2021-08-05 Janssen Biotech, Inc. Anti-CD38 antibodies for treatment of acute myeloid leukemia
SG11201705484WA (en) * 2015-02-09 2017-08-30 Ucb Biopharma Sprl Pharmaceutical formulation
MX389805B (es) 2015-05-20 2025-03-11 Janssen Biotech Inc Anticuerpos anti-cd38 para el tratamiento de amiloidosis de cadena ligera y otras enfermedades malignas 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
DK3827845T3 (da) 2015-11-03 2022-05-23 Janssen Biotech Inc Subkutane formuleringer af anti-cd38-antistoffer og anvendelser deraf
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
JP2019527678A (ja) 2016-06-28 2019-10-03 ユーエムセー・ユトレヒト・ホールディング・ベー・フェー ＣＤ３８に特異的に結合する抗体によるＩｇＥ媒介疾患の治療
WO2018187074A1 (en) 2017-04-03 2018-10-11 Immunomedics, Inc. Subcutaneous administration of antibody-drug conjugates for cancer therapy
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
KR102735988B1 (ko) 2019-02-18 2024-12-03 일라이 릴리 앤드 캄파니 치료 항체 제제
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
AU2021278562A1 (en) 2020-05-29 2022-12-01 Chugai Seiyaku Kabushiki Kaisha Antibody-containing formulation

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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
EP1400536A1 (en) * 1991-06-14 2004-03-24 Genentech Inc. Method for making humanized antibodies
US6267958B1 (en) * 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
AU2002213441B2 (en) * 2000-10-12 2006-10-26 Genentech, Inc. Reduced-viscosity concentrated protein formulations
PH12012502440A1 (en) * 2001-06-26 2013-06-17 Amgen Inc Antibodies to opgl
CA2454587C (en) * 2001-07-25 2012-11-13 Protein Design Labs, Inc. Stable lyophilized pharmaceutical formulation of igg antibodies
AU2003211990A1 (en) * 2002-02-14 2003-09-04 Chugai Seiyaku Kabushiki Kaisha Antibody-containing solution pharmaceuticals
AU2004212344B2 (en) * 2003-02-13 2009-05-07 Pfizer Products Inc. Uses of anti-insulin-like growth factor I receptor antibodies
WO2005016970A2 (en) * 2003-05-01 2005-02-24 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
MXPA06001634A (es) * 2003-08-13 2006-04-28 Pfizer Prod Inc Anticuerpos humanos modificados igf-1r.
AU2006247039B2 (en) * 2005-05-19 2011-03-03 Amgen Inc. Compositions and methods for increasing the stability of antibodies
KR20080019249A (ko) * 2005-06-15 2008-03-03 쉐링 코포레이션 안정한 항체 제형
WO2007110339A1 (en) * 2006-03-28 2007-10-04 F. Hoffmann-La Roche Ag Anti-igf-1r human monoclonal antibody formulation

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104524566A (zh) * 2010-09-17 2015-04-22 巴克斯特国际公司 通过具有组氨酸的水性制剂在弱酸性至中性pH稳定的免疫球蛋白
CN105492019A (zh) * 2013-07-04 2016-04-13 普罗塞纳生物科学有限公司 抗体制剂和方法
CN105492019B (zh) * 2013-07-04 2020-02-11 普罗塞纳生物科学有限公司 抗体制剂和方法
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

Also Published As

Publication number Publication date
IL200321A0 (en) 2010-04-29
AU2008228823A1 (en) 2008-09-25
EP2136839A4 (en) 2010-04-07
BRPI0809112A2 (pt) 2014-08-26
US20100260766A1 (en) 2010-10-14
ZA200905636B (en) 2010-10-27
WO2008116103A2 (en) 2008-09-25
ECSP099642A (es) 2009-11-30
CR11005A (es) 2010-08-05
DOP2009000222A (es) 2009-12-15
CA2681743A1 (en) 2008-09-25
JP2010522208A (ja) 2010-07-01
MX2009010179A (es) 2010-03-15
TN2009000382A1 (en) 2010-12-31
EP2136839A2 (en) 2009-12-30
KR20090113340A (ko) 2009-10-29
UA96473C2 (ru) 2011-11-10
WO2008116103A3 (en) 2009-01-08
EA200970880A1 (ru) 2010-02-26

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Open date: 20100310