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

Info

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

Links

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 [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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (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 (49)

* 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
WO2009113083A1 (en) 2008-03-14 2009-09-17 Biocon Limited A 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.
EP2501408B1 (en) * 2009-11-20 2020-05-27 Biocon Limited Formulations of antibody
FR2958646B1 (fr) 2010-04-07 2012-05-18 Adocia Polysaccharides comportant des groupes fonctionnels carboxyles substitues par un derive d'acide hydrophobe.
BR112012013148A2 (pt) * 2009-12-29 2017-03-21 F Hoffmann - La Roche Ag formulação farmacêutica e uso
JO3417B1 (ar) 2010-01-08 2019-10-20 Regeneron Pharma الصيغ المستقرة التي تحتوي على الأجسام المضادة لمضاد مستقبل( interleukin-6 (il-6r
EP3409289B1 (en) 2010-02-26 2020-09-30 Novo Nordisk A/S Stable antibody containing compositions
PT3345615T (pt) 2010-03-01 2020-01-17 Bayer Healthcare Llc Anticorpos monoclonais otimizados contra inibidor da via do fator tecidual (tfpi)
RU2012153786A (ru) 2010-05-28 2014-07-10 Ново Нордиск А/С Стабильные многодозовые композиции, содержащие антитело и консервант
BR112012033457A2 (pt) * 2010-07-02 2017-04-04 Medimmune Llc formulações de anticorpo.
US8524239B2 (en) 2010-07-09 2013-09-03 The United States of America as represented by the Secrectary, Department of Health and Human Services Photosensitizing antibody-fluorophore conjugates
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
EP3024485B1 (en) 2013-07-23 2020-11-18 Biocon Limited Use of a cd6 binding partner and method based thereon
CN105722859B (zh) * 2013-07-25 2021-05-07 西托姆克斯治疗公司 多特异性抗体、多特异性可活化抗体及其使用方法
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
JP6282745B2 (ja) * 2013-09-12 2018-02-21 ハロザイム インコーポレイテッド 修飾抗上皮成長因子受容体抗体およびその使用法
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
CA2955947A1 (en) 2014-07-25 2016-01-28 Cytomx Therapeutics, Inc. Anti-cd3 antibodies, activatable anti-cd3 antibodies, multispecific anti-cd3 antibodies, multispecific activatable anti-cd3 antibodies, and methods of using the same
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
JP6214790B2 (ja) * 2014-09-16 2017-10-18 イース チャーム リミテッド 抗ｅｇｆｒ抗体および同抗体の使用法
CN112656939B (zh) * 2014-09-22 2023-12-08 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
CA3138083A1 (en) * 2014-12-22 2016-06-30 Systimmune, Inc. Bispecific tetravalent antibodies and methods of making and using thereof
US12428483B2 (en) 2014-12-22 2025-09-30 Systimmune, Inc. Bispecific tetravalent antibodies and methods of making and using thereof
KR101776879B1 (ko) 2015-01-19 2017-09-08 주식회사 녹십자 항-egfr 항체를 포함하는 약학 제제
US10736893B2 (en) 2015-11-06 2020-08-11 Acerta Pharma B.V. Imidazopyrazine inhibitors of Bruton's tyrosine kinase
ES2991182T3 (es) 2016-10-21 2024-12-02 Biocon Ltd Un anticuerpo monoclonal y un método de uso para el tratamiento del lupus
AU2017386888B2 (en) * 2016-12-28 2024-08-08 Jcr Pharmaceuticals Co., Ltd. Lyophilized preparation
US11639391B2 (en) * 2017-04-18 2023-05-02 Dr. Reddy's Laboratories Limited Stable liquid pharmaceutical composition
EP3694885A1 (en) 2017-10-14 2020-08-19 CytomX Therapeutics, Inc. Antibodies, activatable antibodies, bispecific antibodies, and bispecific activatable antibodies and methods of use thereof
SG11202011538RA (en) * 2018-06-01 2020-12-30 Rakuten Medical Inc Phthalocyanine dye conjugate compositions
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
MA54861A (fr) 2019-01-31 2021-12-08 Regeneron Pharma Anticorps anti-récepteur de l'il6 pour traiter l'arthrite idiopathique juvénile
CN120241997A (zh) 2019-02-18 2025-07-04 伊莱利利公司 治疗性抗体制剂
SG11202111742QA (en) 2019-04-24 2021-11-29 Sanofi Biotechnology Methods of diagnosis and treatment of rheumatoid arthritis
CA3142710A1 (en) 2019-06-04 2020-12-10 Sanofi Biotechnology Compositions and methods for treating pain in subjects with rheumatoid arthritis
JP2022535924A (ja) * 2019-06-06 2022-08-10 ジャナックス セラピューティクス，インク． 腫瘍活性化ｔ細胞エンゲージャーに関する組成物および方法
CU20190104A7 (es) * 2019-12-17 2021-08-06 Ct Inmunologia Molecular Formulación estable del anticuerpo nimotuzumab
EP4631977A3 (en) 2020-08-11 2025-12-10 Janux Therapeutics, Inc. Cleavable linker compositions and methods
AU2021396172A1 (en) 2020-12-09 2023-07-06 Janux Therapeutics, Inc. Compositions and methods related to tumor activated antibodies targeting psma and effector cell antigens
US20240383968A1 (en) * 2020-12-11 2024-11-21 Boehringer Ingelheim International Gmbh Formulation for multi-purpose application
JP2024536275A (ja) * 2021-10-03 2024-10-04 システィミューン， インク． がんを治療する方法及びその医薬組成物
CN119855620A (zh) * 2022-09-16 2025-04-18 国立研究开发法人量子科学技术研究开发机构 放射性医药组合物的中间体的制造方法、放射性医药组合物的中间体的纯化用试剂盒

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
CA2560305C (en) * 2004-03-19 2016-07-05 Imclone Systems Incorporated Human anti-epidermal growth factor receptor antibody
CN101495136A (zh) * 2006-02-15 2009-07-29 英克隆系统公司 抗体配制品

Also Published As

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

Similar Documents

Publication Publication Date Title
BRPI0713421A2 (pt) Formulação liofolizada, formulação aquosa adequada para a liofilização, e, métodos para estabilizar am anticorpo e para tratar um mamífero
PE20141159A1 (es) Metodos para tratar o prevenir trastornos relacionados con el colesterol
BRPI0514340A (pt) formulações de estabilização
EA200970880A1 (ru) Стабильные композиции на основе антител
BRPI0818765A8 (pt) Polipeptídeo, anticorpo ou seu fragmento de ligação de antígeno, polinucleotídeo, célula hospedeira, vetor, composição, uso e método para produzir polipeptídeo
CL2020002012A1 (es) Formulaciones de anticuerpos humanos anti-rankl y métodos de uso de estas. (divisional solicitud 201903032)
EA201001204A1 (ru) Методы и композиции, в которых применяют слитые полипептиды klotho-fgf
BR112012018951C8 (pt) anticorpo monoclonal, composição farmacêutica, combinação farmacêutica, uso de um anticorpo, uso de uma composição farmacêutica e uso de uma combinação farmacêutica
BRPI0613382A8 (pt) anticorpos isolados, anticorpo monoclonal, célula de hibridoma, método de identificação, método de inibição do crescimento de uma célula, método de tratamento terapêutico, método de determinação da presença de uma proteína, métodos de diagnósticos da presença de tumor
ECSP10010697A (es) Inhibidores de dpp-iv para uso en el tratamiento de nafld
ECSP088350A (es) Pirazolopirimidinas como inhibidores de protein quinasas
RU2013137740A (ru) Жидкая композиция, содержащая антитело высокой концентрации
CL2011000230A1 (es) Anticuerpo monoclonal humano aislado que se une al inhibidor de la via del factor tisular (tfpi); composicion farmaceutica que lo comprende; uso para tratar deficiencias adquiridas o geneticas de la coagulacion, o para acortar el tiempo de sangrado.
EA201100072A1 (ru) Новые композиции и способы
TW200621804A (en) Ctla-4 antibody and aromatase inhibitor combination treatment for breast cancer
BRPI0516408B8 (pt) derivados de estilbeno e seu uso para ligação e formação de imagem de placas de amilóide
BR112015009037A2 (pt) composição farmacêutica para uso no tratamento de infarto do miocárdio e uso de um peptídeo de fragmento de hmgb1
BR112014009785A8 (pt) método para tratar ou reduzir efp
EA201001749A1 (ru) Способ лечения недифференцированного артрита
GT200600115A (es) Metodo para identificar blancos terapeuticos para el tratamiento de atrofia vulvoginal
BR112013019513A2 (pt) métodos para o tratamento de úlceras diabéticas do pé
BRPI0720230A2 (pt) Uso de uma formulação nutricional oralmente administrável, formulação nutricional, método para tratar um distúrbio desenvolvimental penetrante, e, composição
MA32183B1 (fr) Pyrimidylcyclopentanes hydroxylés utilisés comme inhibiteurs de protéine kinase akt
BR112013000779A2 (pt) composições farmacêuticas de combinação, métodos de tratamento de paciente e uso de forma potencializada ativada de anticorpo para receptor at1 de angiotensina ii e forma potencializada ativada de anticorpo para sintase no endotelial
BRPI0607043A2 (pt) lacosamida para terapia de adição

Legal Events

Date Code Title Description
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.