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

    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • 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
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [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)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Organic Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (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 (37)

* 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)
NZ587632A (en) 2008-03-14 2012-06-29 Biocon Ltd An anti-cd6 monoclonal antibody and a method thereof
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).
US20130064834A1 (en) 2008-12-15 2013-03-14 Regeneron Pharmaceuticals, Inc. Methods for treating hypercholesterolemia using antibodies to pcsk9
MX385311B (es) 2011-01-28 2025-03-18 Sanofi Biotechnology Anticuerpos humanos frente a pcsk9 para su uso en métodos de tratamiento de grupos concretos de pacientes.
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
HUE069234T2 (hu) 2011-09-16 2025-02-28 Regeneron Pharma Eljárások lipoprotein(a)-szint csökkentésére proprotein-konvertáz szubtilizin/kexin 9 (PCSK9) inhibitorának beadásával
NZ627859A (en) 2012-01-23 2015-09-25 Regeneron Pharma Stabilized formulations containing anti-ang2 antibodies
EA039663B1 (ru) 2012-05-03 2022-02-24 Амген Инк. Применение антитела против pcsk9 для снижения сывороточного холестерина лпнп и лечения связанных с холестерином расстройств
AR092325A1 (es) 2012-05-31 2015-04-15 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-dll4 y kit
MX2015003007A (es) 2012-09-07 2015-06-05 Coherus Biosciences Inc Formulaciones acuosas estables de 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
EP2916866B1 (de) 2012-11-06 2018-04-04 Bayer Pharma Aktiengesellschaft Formulierung für bispecific t-cell-engangers (bites)
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)
KR102405247B1 (ko) 2013-07-23 2022-06-07 바이오콘 리미티드 Cd6 결합 파트너의 용도 및 이에 기초한 방법
IL312865B2 (en) 2013-09-11 2025-06-01 Eagle Biologics Inc Liquid protein formulations containing viscosity-lowering agents
EP3068803B1 (en) 2013-11-12 2021-01-20 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
CN107206068A (zh) 2014-07-16 2017-09-26 赛诺菲生物技术公司 用于治疗杂合型家族性高胆固醇血症(heFH)患者的方法
SG11201702614SA (en) 2014-10-01 2017-04-27 Eagle Biolog Inc Polysaccharide and nucleic acid formulations containing viscosity-lowering agents
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
KR20240172758A (ko) 2015-08-18 2024-12-10 리제너론 파아마슈티컬스, 인크. 지단백질 분리반출술을 경험하고 있는 고지혈증을 갖는 환자를 치료하기 위한 항-pcsk9 억제성 항체
US11229702B1 (en) 2015-10-28 2022-01-25 Coherus Biosciences, Inc. High concentration formulations of adalimumab
WO2017184880A1 (en) 2016-04-20 2017-10-26 Coherus Biosciences, Inc. A method of filling a container with no headspace
AU2017333367A1 (en) * 2016-09-27 2019-04-04 Fresenius Kabi Deutschland Gmbh Liquid pharmaceutical composition
PL3529274T3 (pl) 2016-10-21 2024-09-09 Biocon Limited Przeciwciało monoklonalne i sposób jego stosowania w leczeniu tocznia
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
TW202003036A (zh) * 2018-03-23 2020-01-16 德商艾伯維德國有限及兩合公司 穩定水性抗-tau抗體調配物
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
CN113116812A (zh) * 2019-12-30 2021-07-16 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
WO2024083074A1 (en) * 2022-10-17 2024-04-25 Beigene, Ltd. 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
CA2226575C (en) * 1995-07-27 2011-10-18 Genentech, Inc. Stabile isotonic lyophilized protein formulation
US5810597A (en) * 1996-06-21 1998-09-22 Robert H. Allen, Jr. Touch activated audio sign
JP5485489B2 (ja) 2000-08-11 2014-05-07 中外製薬株式会社 抗体含有安定化製剤
AU2002324556A1 (en) * 2001-07-25 2003-02-17 Protein Design Labs, Inc. Stable lyophilized pharmaceutical formulation of igg antibodies
AU2004229335C1 (en) * 2003-04-04 2010-06-17 Genentech, Inc. High concentration antibody and protein formulations
CA2626082C (en) * 2005-10-13 2017-04-11 Human Genome Sciences, Inc. Methods and compositions for use in treatment of patients with autoantibody positive disease
AU2007260769A1 (en) * 2006-06-14 2007-12-21 Imclone Llc Lyophilized formulations of anti-EGFR antibodies
CN101553504A (zh) * 2006-12-11 2009-10-07 豪夫迈·罗氏有限公司 Aβ抗体胃肠外制剂
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
RU2454245C2 (ru) * 2006-12-26 2012-06-27 Сентро Де Инмунология Молекулар Фармацевтические композиции, способные вызывать апоптоз опухолевых клеток, для диагностики и лечения в-клеточной хронической лимфоцитарной лейкемии
WO2008086395A2 (en) * 2007-01-09 2008-07-17 Wyeth 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
US7951368B2 (en) * 2007-06-25 2011-05-31 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
JP2023553209A (ja) * 2020-12-15 2023-12-20 バイカラ セラピューティクス インコーポレイテッド 融合タンパク質の医薬製剤

Also Published As

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

Similar Documents

Publication Publication Date Title
MX2012005863A (es) Formulaciones de anticuerpos.
CY1123909T1 (el) Σταθεροποιημενα σκευασματα που περιεχουν αντισωματα κατα του υποδοχεα της ιντερλευκινης-6 (il-6r)
CR11005A (es) Formulaciones estables de anticuerpos
AR079556A1 (es) Formacion de anticuerpos
CO6751287A2 (es) Composición antigénetica de micobacteria
PH12014501628A1 (en) Stabilized formulations containing anti-ang2 antibodies
PE20141175A1 (es) FORMULACION PARA ANTICUERPO ANTI-alfa4�7
DOP2009000157A (es) Agentes para combatir parasitos en animales
BRPI0915076A2 (pt) composições de vacina, composição imunogênica, método para expressão dos antígenos quiméricos de hpv-hbsag supramencionados, composição farmacêutica, método para ocasionar resposta de anticorpo protetor para composição antigênica e/ou resposta de célula t citotóxica, uso das formulações antigênicas supramencionadas.
DK1802344T3 (da) Antistofformulering i histidin-acetat-puffer.
AR061400A1 (es) Agentes para suprimir el dano a los islotes transplantados despues del transplante de islotes
AR061348A1 (es) Preparados estables de laquinimod
CL2012002695A1 (es) Articulo para fumar, que comprende una primera parte que contiene una fuente de material para fumar y una segunda parte que tiene al menos un extremo que esta configurado para desplazarse en relacion con la primera parte, en donde el articulo ademas comprende un agente modificador de humo que se libera en el articulo para fumar; y envase.
AR057237A1 (es) Metodos y composiciones para actuar sobre la poliubiquitina
CR20120310A (es) Anticuerpos neutralizadores contra el receptor de prolactina y su uso terapéutico
EP4219560A3 (en) Integrin alpha v beta 8 neutralizing antibody
CL2012000508A1 (es) Composicion para la aplicacion en cultivos agricolas al aire libre o invernaderos que comprende zeolita, y aditivos; uso de la composicion para aumentar el rendimiento de los cultivos agricolas.
PH12013500672A1 (en) Stabilized formulations containing anti-interleukin-4-receptor (il-4r) antibodies
WO2011028961A3 (en) Anti-botulism antibody coformulations
BR112013013117A2 (pt) agente hidrotrópico, uso do mesmo para tornar solúveis tensoativos não iônicos e composições contendo os mesmos
BR112014003139A2 (pt) musgo de turfa umectável resistente à lixiviação, método de preparação, e método de uso
ECSP13013093A (es) Composiciones líquidas de limpieza de sal
AR082423A1 (es) Composicion detergente liquida
WO2012006367A3 (en) Compositions and methods for treating influenza
CL2011002994A1 (es) Construccion de proteina que comprende polipeptido casb7439; composicion inmunogenica que comprende dicha construccion; uso de la composicion porque sirve para inducir respuesta inmunitaria al casb7439 en un animal.