BRPI0713421A2 - Formulação liofolizada, formulação aquosa adequada para a liofilização, e, métodos para estabilizar am anticorpo e para tratar um mamífero - Google Patents

Formulação liofolizada, formulação aquosa adequada para a liofilização, e, métodos para estabilizar am anticorpo e para tratar um mamífero Download PDF

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Publication number
BRPI0713421A2
BRPI0713421A2 BRPI0713421-5A BRPI0713421A BRPI0713421A2 BR PI0713421 A2 BRPI0713421 A2 BR PI0713421A2 BR PI0713421 A BRPI0713421 A BR PI0713421A BR PI0713421 A2 BRPI0713421 A2 BR PI0713421A2
Authority
BR
Brazil
Prior art keywords
formulation
antibody
methods
liofolized
liophilization
Prior art date
Application number
BRPI0713421-5A
Other languages
English (en)
Inventor
Agarkhed Meera
Srivastava Arvind
Goldstein Joel
Original Assignee
Imclone Systems Incorporated
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 Incorporated filed Critical Imclone Systems Incorporated
Publication of BRPI0713421A2 publication Critical patent/BRPI0713421A2/pt

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Classifications

    • 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
    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7012—Compounds having a free or esterified carboxyl group attached, directly or through a carbon chain, to a carbon atom of the saccharide radical, e.g. glucuronic acid, neuraminic acid
    • 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
    • A61P35/04—Antineoplastic agents specific for metastasis
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

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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)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oncology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)

Abstract

FORMULAçãO LIOFILIZADA, FORMULAçãO AQUOSA ADEQUADA PARA A LIOFILIZAçãO, E, MéTODOS PARA ESTABILIZAR UM ANTICORPO E PARA TRATAR UM MAMìFERO. Em uma forma de realização, a presente invenção fornece uma formulação liofilizada estável que compreende um anticorpo anti-EGFR, preferivelmente cetuximab; ácido lactobiónico; e um tampão, preferivelmente histidina. Em uma forma de realização preferida, a presente invenção fornece uma formulação liofilizada estável que compreende cerca de 50 mg/ml a cerca de 140 mg/ml de ERBITUX?, cerca de 0,125% de ácido lactobiónico, cerca de 25 mM de tampão de histidina em um pH de cerca de 6,0, cerca de 0,005% de Tween 80 e cerca de 1,875% de glicina.
BRPI0713421-5A 2006-06-14 2007-06-13 Formulação liofolizada, formulação aquosa adequada para a liofilização, e, métodos para estabilizar am anticorpo e para tratar um mamífero BRPI0713421A2 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US81395806P 2006-06-14 2006-06-14
US60/813958 2006-06-14
PCT/US2007/071119 WO2007147001A2 (en) 2006-06-14 2007-06-13 Lyophilized formulations of anti-egfr antibodies

Publications (1)

Publication Number Publication Date
BRPI0713421A2 true BRPI0713421A2 (pt) 2012-03-13

Family

ID=38832820

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0713421-5A BRPI0713421A2 (pt) 2006-06-14 2007-06-13 Formulação liofolizada, formulação aquosa adequada para a liofilização, e, métodos para estabilizar am anticorpo e para tratar um mamífero

Country Status (18)

Country Link
US (1) US20100158925A1 (pt)
EP (1) EP2029163A4 (pt)
JP (1) JP2009540015A (pt)
KR (1) KR20090021298A (pt)
CN (1) CN101466404A (pt)
AU (1) AU2007260769A1 (pt)
BR (1) BRPI0713421A2 (pt)
CA (1) CA2654794A1 (pt)
CR (1) CR10493A (pt)
EA (1) EA200870538A1 (pt)
EC (1) ECSP088962A (pt)
IL (1) IL195794A0 (pt)
MA (1) MA30515B1 (pt)
MX (1) MX2008015852A (pt)
NO (1) NO20085131L (pt)
TN (1) TNSN08511A1 (pt)
WO (1) WO2007147001A2 (pt)
ZA (1) ZA200810456B (pt)

Families Citing this family (45)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2094247B1 (en) * 2006-10-20 2022-06-29 Amgen Inc. Stable polypeptide formulations
US8524233B2 (en) 2008-03-14 2013-09-03 Biocon Limited & Centro de Immunologia Molecular Monoclonal antibody and a method thereof
CN101716343A (zh) * 2008-10-09 2010-06-02 哈药集团生物工程有限公司 一种单克隆抗体的冻干制剂
FR2944448B1 (fr) * 2008-12-23 2012-01-13 Adocia Composition pharmaceutique stable comprenant au moins un anticorps monodonal et au moins un polysacharide amphiphile comprenant des substituants derives d'alcools hydrofobes ou d'amines hydrophobes.
PT3721904T (pt) * 2009-11-20 2021-11-15 Biocon Ltd Formulações de anticorpo t1h
FR2958646B1 (fr) 2010-04-07 2012-05-18 Adocia Polysaccharides comportant des groupes fonctionnels carboxyles substitues par un derive d'acide hydrophobe.
AU2010338305A1 (en) * 2009-12-29 2012-05-24 F. Hoffmann-La Roche Ag Antibody formulation
JO3417B1 (ar) 2010-01-08 2019-10-20 Regeneron Pharma الصيغ المستقرة التي تحتوي على الأجسام المضادة لمضاد مستقبل( interleukin-6 (il-6r
EP3708190A1 (en) 2010-02-26 2020-09-16 Novo Nordisk A/S Stable antibody containing compositions
CA3101298A1 (en) 2010-03-01 2011-09-09 Bayer Healthcare Llc Optimized monoclonal antibodies against tissue factor pathway inhibitor (tfpi)
US20130136733A1 (en) 2010-05-28 2013-05-30 Novo Nordisk A/S Stable Multi-Dose Compositions Comprising an Antibody and a Preservative
CN103108658B (zh) * 2010-07-02 2015-08-19 米迪缪尼有限公司 抗体制剂
UY34105A (es) 2011-06-03 2012-07-31 Lg Life Sciences Ltd Formulación líquida estable de etanercept
TWI589299B (zh) 2011-10-11 2017-07-01 再生元醫藥公司 用於治療類風濕性關節炎之組成物及其使用方法
US9592297B2 (en) 2012-08-31 2017-03-14 Bayer Healthcare Llc Antibody and protein formulations
DK3024485T3 (da) 2013-07-23 2020-12-07 Biocon Ltd Anvendelse af en CD6-bindingspartner og fremgangsmåde baseret derpå
CA2918795A1 (en) * 2013-07-25 2015-01-29 Cytomx Therapeutics, Inc. Multispecific antibodies, multispecific activatable antibodies and methods of using the same
CN104341505A (zh) * 2013-07-29 2015-02-11 西藏海思科药业集团股份有限公司 对蒙古人种和高加索人种低免疫原性的、抗egfr的人鼠嵌合抗体
EP3044236A2 (en) * 2013-09-12 2016-07-20 Halozyme, Inc. Modified anti-epidermal growth factor receptor antibodies and methods of use thereof
WO2015185998A2 (en) 2014-04-11 2015-12-10 Acerta Pharma B.V. Methods of blocking the cxcr-4/sdf-1 signaling pathway with inhibitors of bone marrow x kinase
US9937171B2 (en) 2014-04-11 2018-04-10 Acerta Pharma B.V. Methods of blocking the CXCR-4/SDF-1 signaling pathway with inhibitors of bruton's tyrosine kinase
CN107108738A (zh) 2014-07-25 2017-08-29 西托姆克斯治疗公司 抗cd3抗体、可活化抗cd3抗体、多特异性抗cd3抗体、多特异性可活化抗cd3抗体及其使用方法
TW201618774A (zh) 2014-08-11 2016-06-01 艾森塔製藥公司 使用ｂｔｋ抑制劑透過調變腫瘤微環境來治療實體腫瘤及其他疾病之方法
EP3110447B1 (en) * 2014-09-16 2020-04-29 Synermore Biologics Co., Ltd. Anti-egfr antibody and uses of same
CN105435221B (zh) * 2014-09-22 2021-09-28 正大天晴药业集团股份有限公司 一种针对血管内皮生长因子的人源化抗体的药物组合物
WO2016055982A1 (en) 2014-10-10 2016-04-14 Acerta Pharma B.V. Quinoline and quinazoline compounds
WO2016087994A1 (en) 2014-12-05 2016-06-09 Acerta Pharma B.V. Btk inhibitors to treat solid tumors through modulation of the tumor microenvironment
KR20230149328A (ko) * 2014-12-22 2023-10-26 시스트이뮨, 인코포레이티드 이중특이적 4가 항체 및 이의 제조 및 사용방법
KR101776879B1 (ko) * 2015-01-19 2017-09-08 주식회사 녹십자 항-egfr 항체를 포함하는 약학 제제
JP6890602B2 (ja) 2015-11-06 2021-06-18 アセルタ ファーマ ビー．ブイ． ブルトン型チロシンキナーゼのイミダゾピラジン阻害剤
DK3529274T3 (da) 2016-10-21 2024-06-17 Biocon Ltd Monoklonalt antistof og fremgangsmåde til anvendelse til behandling af lupus
BR112019013202A2 (pt) * 2016-12-28 2019-12-10 Japan Chem Res formulação liofilizada
US11639391B2 (en) * 2017-04-18 2023-05-02 Dr. Reddy's Laboratories Limited Stable liquid pharmaceutical composition
WO2019075405A1 (en) 2017-10-14 2019-04-18 Cytomx Therapeutics, Inc. ANTIBODIES, ACTIVISTIC ANTIBODIES, BISPECIFIC ANTIBODIES, AND BISPECIFICALLY ACTIVATED ANTIBODIES AND METHODS OF USE THEREOF
CN112512583B (zh) * 2018-06-01 2023-11-14 乐天医药生技股份有限公司 酞菁染料偶联物组合物
CN110960490A (zh) * 2018-09-28 2020-04-07 江苏恒瑞医药股份有限公司 一种抗egfr抗体偶联药物组合物及其用途
US11498969B2 (en) 2019-01-31 2022-11-15 Sanofi Biotechnology Compositions and methods for treating juvenile idiopathic arthritis
CR20210435A (es) 2019-02-18 2021-09-20 Lilly Co Eli Formulación de anticuerpos terapéuticos
EP3980131A4 (en) * 2019-06-06 2023-06-28 Janux Therapeutics, Inc. Compositions and methods relating to tumor activated t cell engagers
CU20190104A7 (es) * 2019-12-17 2021-08-06 Ct Inmunologia Molecular Formulación estable del anticuerpo nimotuzumab
JP2023547978A (ja) 2020-08-11 2023-11-15 ジャナックス セラピューティクス，インク． 切断可能リンカー組成物および方法
WO2022125576A1 (en) 2020-12-09 2022-06-16 Janux Therapeutics, Inc. Compositions and methods related to tumor activated antibodies targeting psma and effector cell antigens
KR20230118167A (ko) * 2020-12-11 2023-08-10 베링거 인겔하임 인터내셔날 게엠베하 다목적 적용을 위한 제형
IL311698A (en) * 2021-10-03 2024-05-01 Systimmune Inc Cancer treatment methods and preparations and medicines for this
WO2024058201A1 (ja) * 2022-09-16 2024-03-21 国立研究開発法人量子科学技術研究開発機構 放射性医薬組成物の中間体の製造方法、放射性医薬組成物の中間体の精製用キット

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS62158160A (ja) * 1985-12-27 1987-07-14 堺化学工業株式会社 成形触媒及び接触反応方法
US6685940B2 (en) * 1995-07-27 2004-02-03 Genentech, Inc. Protein formulation
US6695940B2 (en) * 2001-04-05 2004-02-24 Alan D. Devoe Laminate thin-wall ceramic tubes, including with integral stress wrappings, thickened ends and/or internal baffles, particularly for solid oxide fuel cells
DE10163459A1 (de) * 2001-12-21 2003-07-03 Merck Patent Gmbh Lyophilisierte Zubereitung enthaltend Antikörper gegen EGF-Rezeptor
EP1735348B1 (en) * 2004-03-19 2012-06-20 Imclone LLC Human anti-epidermal growth factor receptor antibody
CA2642270A1 (en) * 2006-02-15 2007-08-23 Imclone Systems Incorporated Antibody formulation

Also Published As

Publication number Publication date
MA30515B1 (fr) 2009-06-01
CR10493A (es) 2009-02-26
ECSP088962A (es) 2009-01-30
AU2007260769A1 (en) 2007-12-21
ZA200810456B (en) 2009-12-30
EP2029163A2 (en) 2009-03-04
CN101466404A (zh) 2009-06-24
US20100158925A1 (en) 2010-06-24
KR20090021298A (ko) 2009-03-02
IL195794A0 (en) 2011-08-01
EA200870538A1 (ru) 2009-04-28
MX2008015852A (es) 2009-02-23
NO20085131L (no) 2009-03-13
JP2009540015A (ja) 2009-11-19
TNSN08511A1 (en) 2010-04-14
EP2029163A4 (en) 2010-08-11
CA2654794A1 (en) 2007-12-21
WO2007147001A2 (en) 2007-12-21
WO2007147001A3 (en) 2008-07-10

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Legal Events

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B25D Requested change of name of applicant approved

Owner name: IMCLONE LLC (US)

Free format text: NOME ALTERADO DE: IMCLONE SYSTEMS INCORPORATED

B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]

Free format text: REFERENTE A 5A ANUIDADE.

B08K Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]

Free format text: NAO APRESENTADA A GUIA DE CUMPRIMENTO DE EXIGENCIA. REFERENTE A 5A ANUIDADE.