CU20120080A7 - Formulaciones de anticuerpo - Google Patents

Formulaciones de anticuerpo

Info

Publication number
CU20120080A7
CU20120080A7 CU2012000080A CU20120080A CU20120080A7 CU 20120080 A7 CU20120080 A7 CU 20120080A7 CU 2012000080 A CU2012000080 A CU 2012000080A CU 20120080 A CU20120080 A CU 20120080A CU 20120080 A7 CU20120080 A7 CU 20120080A7
Authority
CU
Cuba
Prior art keywords
antibody formulations
formulations
cryoprotectants
cryoprotectant
buffer
Prior art date
Application number
CU2012000080A
Other languages
English (en)
Inventor
Karthik Ramani
Sucharitha Jayakar
Original Assignee
Biocon Ltd
Ct De Inmunología Molecular
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 Biocon Ltd, Ct De Inmunología Molecular filed Critical Biocon Ltd
Publication of CU20120080A7 publication Critical patent/CU20120080A7/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies

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)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Organic Chemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Formulación estable farmacéuticamente que contiene anticuerpos, un búfer, un surfactante no iónico y lioprotectores/crioprotectores. Además se dan a conocer métodos asociados para la preparación, almacenamiento y uso de dichas formulaciones.
CU2012000080A 2009-11-20 2012-05-21 Formulaciones de anticuerpo CU20120080A7 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN2859CH2009 2009-11-20
PCT/IB2010/055296 WO2011061712A1 (en) 2009-11-20 2010-11-19 Formulations of antibody

Publications (1)

Publication Number Publication Date
CU20120080A7 true CU20120080A7 (es) 2012-10-15

Family

ID=44059267

Family Applications (1)

Application Number Title Priority Date Filing Date
CU2012000080A CU20120080A7 (es) 2009-11-20 2012-05-21 Formulaciones de anticuerpo

Country Status (20)

Country Link
US (4) US20120231009A1 (es)
EP (2) EP2501408B1 (es)
JP (2) JP5896471B2 (es)
KR (1) KR101333276B1 (es)
CN (1) CN102770157B (es)
AU (1) AU2010320515B2 (es)
BR (1) BR112012012080B1 (es)
CA (1) CA2781467C (es)
CU (1) CU20120080A7 (es)
DK (1) DK3721904T3 (es)
ES (1) ES2897500T3 (es)
IL (1) IL219884A (es)
MX (1) MX2012005863A (es)
MY (1) MY165614A (es)
NZ (1) NZ600096A (es)
PL (1) PL3721904T3 (es)
PT (1) PT3721904T (es)
RU (1) RU2548772C2 (es)
WO (1) WO2011061712A1 (es)
ZA (1) ZA201204459B (es)

Families Citing this family (36)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JOP20080381B1 (ar) 2007-08-23 2023-03-28 Amgen Inc بروتينات مرتبطة بمولدات مضادات تتفاعل مع بروبروتين كونفيرتاز سيتيليزين ككسين من النوع 9 (pcsk9)
ES2759075T3 (es) 2008-03-14 2020-05-07 Biocon Ltd Un anticuerpo monoclonal y un método del mismo
US20130064834A1 (en) 2008-12-15 2013-03-14 Regeneron Pharmaceuticals, Inc. Methods for treating hypercholesterolemia using antibodies to pcsk9
JO3672B1 (ar) 2008-12-15 2020-08-27 Regeneron Pharma أجسام مضادة بشرية عالية التفاعل الكيماوي بالنسبة لإنزيم سبتيليسين كنفرتيز بروبروتين / كيكسين نوع 9 (pcsk9).
BR112013018740A2 (pt) 2011-01-28 2019-01-08 Sanofi Sa anticorpos humanos para pcsk9 para uso em métodos de tratamento de grupos específicos de indivíduos
JOP20200043A1 (ar) 2011-05-10 2017-06-16 Amgen Inc طرق معالجة أو منع الاضطرابات المختصة بالكوليسترول
AR087305A1 (es) * 2011-07-28 2014-03-12 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit
CN103930444B (zh) 2011-09-16 2020-08-04 瑞泽恩制药公司 用前蛋白转化酶枯草溶菌素-9(PCSK9)抑制剂降低脂蛋白(a)水平的方法
AU2013212587B2 (en) 2012-01-23 2017-07-20 Regeneron Pharmaceuticals, Inc. Stabilized formulations containing anti-Ang2 antibodies
AR092325A1 (es) 2012-05-31 2015-04-15 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-dll4 y kit
AU2013312300A1 (en) 2012-09-07 2015-04-16 Coherus Biosciences, Inc. Stable aqueous formulations of adalimumab
CN102961745B (zh) * 2012-09-27 2015-02-18 苏州康聚生物科技有限公司 抗体组合物制剂及其应用
CN104780940B (zh) 2012-11-06 2017-11-07 拜耳制药股份公司 用于双特异性t细胞衔接体(bites)的制剂
US10111953B2 (en) 2013-05-30 2018-10-30 Regeneron Pharmaceuticals, Inc. Methods for reducing remnant cholesterol and other lipoprotein fractions by administering an inhibitor of proprotein convertase subtilisin kexin-9 (PCSK9)
PT3024485T (pt) 2013-07-23 2021-01-25 Biocon Ltd Utilização de um parceiro de ligação de cd6 e método baseado no mesmo
IL312865B2 (en) 2013-09-11 2025-06-01 Eagle Biologics Inc Liquid protein formulations containing viscosity-lowering agents
US10428157B2 (en) 2013-11-12 2019-10-01 Sanofi Biotechnology Dosing regimens for use with PCSK9 inhibitors
WO2015181757A1 (en) * 2014-05-28 2015-12-03 Nono Inc. Lyophilized formulation of tat-nr2b9c with acetylation scavenger
KR20230074283A (ko) 2014-07-16 2023-05-26 사노피 바이오테크놀로지 이형접합성 가족성 고콜레스테롤혈증(heFH) 환자의 치료방법
JP6716577B2 (ja) 2014-10-01 2020-07-01 イーグル・バイオロジクス・インコーポレイテッドEagle Biologics, Inc. 粘度低下物質を含有する、多糖および核酸の調合薬
CN104922668B (zh) * 2014-12-10 2019-08-23 信达生物制药(苏州)有限公司 一种稳定的抗vegf抗体制剂及其用途
KR101776879B1 (ko) 2015-01-19 2017-09-08 주식회사 녹십자 항-egfr 항체를 포함하는 약학 제제
JP2018523684A (ja) 2015-08-18 2018-08-23 リジェネロン・ファーマシューティカルズ・インコーポレイテッドRegeneron Pharmaceuticals, Inc. リポタンパク質アフェレーシスを受けている高脂血症の患者を治療するための抗pcsk9阻害抗体
US11229702B1 (en) 2015-10-28 2022-01-25 Coherus Biosciences, Inc. High concentration formulations of adalimumab
US11071782B2 (en) 2016-04-20 2021-07-27 Coherus Biosciences, Inc. Method of filling a container with no headspace
KR102546471B1 (ko) * 2016-09-27 2023-06-21 프레제니우스 카비 도이치란트 게엠베하 액상의 약학 조성물
EP3529274B1 (en) 2016-10-21 2024-04-17 Biocon Limited A monoclonal antibody and a method of use for the treatment of lupus
CN106800598B (zh) * 2017-02-09 2020-08-07 广州桂雨生物科技有限公司 一种抗体保存液及其制备方法
WO2019180261A1 (en) * 2018-03-23 2019-09-26 AbbVie Deutschland GmbH & Co. KG Stable aqueous anti-tau antibody formulations
CN111110841A (zh) * 2018-10-31 2020-05-08 上海君实生物医药科技股份有限公司 含有抗pcsk9抗体的稳定制剂
SG11202108627SA (en) 2019-02-18 2021-09-29 Lilly Co Eli Therapeutic antibody formulation
WO2021136274A1 (zh) * 2019-12-30 2021-07-08 百奥泰生物制药股份有限公司 含抗Trop2抗体-药物偶联物的制剂及其制备方法和应用
US11498626B2 (en) * 2020-11-11 2022-11-15 Rivian Ip Holdings, Llc Vehicle tailgate assembly
CN113289027B (zh) * 2021-05-18 2022-07-01 中国兽医药品监察所 一种通用型单克隆抗体耐热保护剂
EP4605002A1 (en) * 2022-10-17 2025-08-27 BeiGene Switzerland GmbH Formulations containing anti-tigit antibody and methods of use thereof
CN117214426A (zh) * 2023-09-20 2023-12-12 暨南大学 一种用于免疫组织化学检测的抗体稀释液及其制备方法

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6267958B1 (en) * 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
PT1516628E (pt) * 1995-07-27 2013-09-24 Genentech Inc Formulação de proteína liofilizada isotónica estável
US5810597A (en) * 1996-06-21 1998-09-22 Robert H. Allen, Jr. Touch activated audio sign
US8632778B2 (en) 2000-08-11 2014-01-21 Chugai Seiyaku Kabushiki Kaisha Stabilized anti-interleukin-6 antibody-containing preparations
WO2003009817A2 (en) 2001-07-25 2003-02-06 Protein Design Labs, Inc. Stable lyophilized pharmaceutical formulation of igg antibodies
HRP20050934B1 (hr) * 2003-04-04 2014-09-26 Genentech, Inc. Formulacije s visokom koncentracijom antitijela i proteina
NZ597082A (en) * 2005-10-13 2013-11-29 Human Genome Sciences Inc Methods and Compositions for Use in Treatment of Patients with Autoantibody Positive Diseases
EP2029163A4 (en) * 2006-06-14 2010-08-11 Imclone Llc LYOPHILIZED FORMULATIONS OF ANTI-EGFR ANTIBODIES
BRPI0721097A2 (pt) * 2006-12-11 2014-07-01 Hoffmann La Roche Formulação parenteral de anticorpo abeta
CN101199483B (zh) * 2006-12-14 2011-01-26 上海中信国健药业股份有限公司 一种稳定的抗her2人源化抗体制剂
EP2119453B1 (en) * 2006-12-26 2015-05-20 Centro de Inmunolgía Molecular Pharmaceutical compositions capable of inducing apoptosis in tumour cells, useful for diagnosis and treatment of b-chronic lymphocytic leukaemia
EP2114451A2 (en) * 2007-01-09 2009-11-11 Wyeth a Corporation of the State of Delaware Anti-il-13 antibody formulations and uses thereof
US20090208492A1 (en) * 2007-06-14 2009-08-20 Elan Pharmaceuticals, Inc. Lyophilized Immunoglobulin Formulations and Methods of Preparation
WO2009002521A2 (en) * 2007-06-25 2008-12-31 Amgen Inc. Compositions of specific binding agents to hepatocyte growth factor
WO2009037190A2 (en) * 2007-09-21 2009-03-26 F. Hoffmann-La Roche Ag Pharmaceutical formulation for il-ir antibody
US20240084018A1 (en) * 2020-12-15 2024-03-14 Bicara Therapeutics Inc. Pharmaceutical formulations for fusion proteins

Also Published As

Publication number Publication date
US20210290525A1 (en) 2021-09-23
JP5896471B2 (ja) 2016-03-30
DK3721904T3 (da) 2021-11-15
BR112012012080A2 (es) 2021-11-03
JP2016104780A (ja) 2016-06-09
CN102770157B (zh) 2017-05-17
EP2501408A4 (en) 2014-10-08
US20240058263A1 (en) 2024-02-22
BR112012012080B1 (pt) 2022-11-29
ZA201204459B (en) 2013-02-27
KR101333276B1 (ko) 2013-11-27
PL3721904T3 (pl) 2022-01-31
EP3721904B1 (en) 2021-10-13
AU2010320515A1 (en) 2012-06-14
AU2010320515B2 (en) 2013-05-02
CA2781467A1 (en) 2011-05-26
EP3721904A1 (en) 2020-10-14
NZ600096A (en) 2013-08-30
CN102770157A (zh) 2012-11-07
EP2501408A1 (en) 2012-09-26
ES2897500T3 (es) 2022-03-01
MY165614A (en) 2018-04-18
CA2781467C (en) 2015-10-13
US20120231009A1 (en) 2012-09-13
MX2012005863A (es) 2013-01-18
IL219884A0 (en) 2012-07-31
IL219884A (en) 2015-11-30
KR20130028894A (ko) 2013-03-20
RU2548772C2 (ru) 2015-04-20
EP2501408B1 (en) 2020-05-27
ES2897500T8 (es) 2022-03-10
JP2013511510A (ja) 2013-04-04
PT3721904T (pt) 2021-11-15
WO2011061712A1 (en) 2011-05-26
RU2012125254A (ru) 2013-12-27
US20190321285A1 (en) 2019-10-24

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