MX2012005863A - Formulaciones de anticuerpos. - Google Patents

Formulaciones de anticuerpos.

Info

Publication number
MX2012005863A
MX2012005863A MX2012005863A MX2012005863A MX2012005863A MX 2012005863 A MX2012005863 A MX 2012005863A MX 2012005863 A MX2012005863 A MX 2012005863A MX 2012005863 A MX2012005863 A MX 2012005863A MX 2012005863 A MX2012005863 A MX 2012005863A
Authority
MX
Mexico
Prior art keywords
formulations
antibody
lyoprotectants
cryoprotectants
buffer
Prior art date
Application number
MX2012005863A
Other languages
English (en)
Inventor
Karthik Ramani
Sucharitha Jayakar
Original Assignee
Centro Inmunologia 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 Centro Inmunologia Molecular filed Critical Centro Inmunologia Molecular
Publication of MX2012005863A publication Critical patent/MX2012005863A/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 [IGs], e.g. monoclonal or polyclonal antibodies

Abstract

Formulación estable farmacéuticamente que contiene anticuerpos, un búfer, un surfactante no iónico, y lioprotectores/crioprotector es. Además se dan a conocer métodos asociados para la preparación, almacenamiento y uso de dichas formulaciones.
MX2012005863A 2009-11-20 2010-11-19 Formulaciones de anticuerpos. MX2012005863A (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
MX2012005863A true MX2012005863A (es) 2013-01-18

Family

ID=44059267

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2012005863A MX2012005863A (es) 2009-11-20 2010-11-19 Formulaciones de anticuerpos.

Country Status (20)

Country Link
US (4) US20120231009A1 (es)
EP (2) EP3721904B1 (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 (32)

* 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)
PL2993186T3 (pl) 2008-03-14 2020-02-28 Biocon Limited Przeciwciało monoklonalne i sposób jego otrzymywania
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
WO2012101253A1 (en) 2011-01-28 2012-08-02 Sanofi Pharmaceutical compositions comprising human antibodies to pcsk9
AR087305A1 (es) * 2011-07-28 2014-03-12 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit
EP3536712B1 (en) 2011-09-16 2023-05-31 Regeneron Pharmaceuticals, Inc. Methods for reducing lipoprotein(a) levels by administering an inhibitor of proprotein convertase subtilisin kexin-9 (pcsk9)
SG11201403792TA (en) 2012-01-23 2014-10-30 Regeneron Pharma 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
KR102238677B1 (ko) 2012-09-07 2021-04-12 코히러스 바이오사이언시즈, 인코포레이티드 아달리무맙의 안정한 수성 제형
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
WO2014072277A1 (de) 2012-11-06 2014-05-15 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)
NZ746944A (en) 2013-07-23 2021-07-30 Biocon Ltd Use of a cd6 binding partner and method based thereon
EP3791862A1 (en) 2013-09-11 2021-03-17 Eagle Biologics, Inc. Liquid protein formulations containing viscosity-lowering agents
KR20160081978A (ko) 2013-11-12 2016-07-08 사노피 바이오테크놀로지 Ｐｃｓｋ9 억제제의 사용을 위한 투약 요법
US10206878B2 (en) * 2014-05-28 2019-02-19 Nono Inc. Lyophilized formulation of TAT-NR2B9C with acetylation scavenger
PL3169353T3 (pl) 2014-07-16 2020-06-01 Sanofi Biotechnology SPOSOBY LECZENIA PACJENTÓW Z HETEROZYGOTYCZNĄ HIPERCHOLESTEROLEMIĄ RODZINNĄ (heFH)
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
CA2995645A1 (en) 2015-08-18 2017-02-23 Regeneron Pharmaceuticals, Inc. Anti-pcsk9 inhibitory antibodies for treating patients with hyperlipidemia undergoing lipoprotein apheresis
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
CA3037440A1 (en) * 2016-09-27 2018-04-05 Fresenius Kabi Deutschland Gmbh Liquid pharmaceutical composition
AU2017344462A1 (en) 2016-10-21 2019-05-02 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
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
MA55033A (fr) 2019-02-18 2021-12-29 Lilly Co Eli Formulation d'anticorps thérapeutique
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

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11510170A (ja) * 1995-07-27 1999-09-07 ジェネンテック インコーポレーテッド タンパク質の処方
US6267958B1 (en) * 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
US5810597A (en) * 1996-06-21 1998-09-22 Robert H. Allen, Jr. Touch activated audio sign
ES2644275T3 (es) 2000-08-11 2017-11-28 Chugai Seiyaku Kabushiki Kaisha Preparaciones estabilizadas que contienen anticuerpos
MXPA04000747A (es) * 2001-07-25 2004-07-08 Protein Desing Labs Inc Formulacion farmaceutica liofilizada estable de anticuerpos igg.
BRPI0403964B8 (pt) * 2003-04-04 2021-05-25 Genentech Inc formulações líquidas estáveis, artigo manufaturado e uso dessas formulações para o tratamento de disfunção mediada por ige
KR20140077946A (ko) * 2005-10-13 2014-06-24 휴먼 게놈 사이언시즈, 인코포레이티드 자가항체 양성 질환 환자의 치료에 유용한 방법 및 조성물
WO2007147001A2 (en) * 2006-06-14 2007-12-21 Imclone Systems Incorporated Lyophilized formulations of anti-egfr antibodies
MX2009006199A (es) * 2006-12-11 2009-06-22 Hoffmann La Roche Formulacion parenteral de anticuerpos 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
CN101678101B (zh) * 2006-12-26 2012-11-07 分子免疫中心 可用于诊断和治疗b细胞慢性淋巴细胞白血病的能够在肿瘤细胞中诱导凋亡的药物组合物
CL2008000058A1 (es) * 2007-01-09 2008-05-23 Wyeth Corp Formulacion que comprende un anticuerpo anti-il13, un criprotector, y una solucion amortiguadora; composicion farmaceutica que la comprende; metodo para tratar un trastorno relacionado con il13; y formas farmaceuticas que la comprenden.
US20090208492A1 (en) * 2007-06-14 2009-08-20 Elan Pharmaceuticals, Inc. Lyophilized Immunoglobulin Formulations and Methods of Preparation
CA2692165A1 (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

Also Published As

Publication number Publication date
PT3721904T (pt) 2021-11-15
IL219884A0 (en) 2012-07-31
NZ600096A (en) 2013-08-30
CN102770157A (zh) 2012-11-07
AU2010320515B2 (en) 2013-05-02
BR112012012080A2 (es) 2021-11-03
ES2897500T8 (es) 2022-03-10
DK3721904T3 (da) 2021-11-15
JP5896471B2 (ja) 2016-03-30
WO2011061712A1 (en) 2011-05-26
IL219884A (en) 2015-11-30
JP2013511510A (ja) 2013-04-04
RU2012125254A (ru) 2013-12-27
EP3721904B1 (en) 2021-10-13
KR101333276B1 (ko) 2013-11-27
US20120231009A1 (en) 2012-09-13
US20240058263A1 (en) 2024-02-22
JP2016104780A (ja) 2016-06-09
MY165614A (en) 2018-04-18
EP3721904A1 (en) 2020-10-14
CN102770157B (zh) 2017-05-17
CA2781467C (en) 2015-10-13
US20210290525A1 (en) 2021-09-23
RU2548772C2 (ru) 2015-04-20
CU20120080A7 (es) 2012-10-15
ZA201204459B (en) 2013-02-27
EP2501408A4 (en) 2014-10-08
EP2501408A1 (en) 2012-09-26
KR20130028894A (ko) 2013-03-20
PL3721904T3 (pl) 2022-01-31
EP2501408B1 (en) 2020-05-27
CA2781467A1 (en) 2011-05-26
BR112012012080B1 (pt) 2022-11-29
US20190321285A1 (en) 2019-10-24
AU2010320515A1 (en) 2012-06-14
ES2897500T3 (es) 2022-03-01

Similar Documents

Publication Publication Date Title
MX2012005863A (es) Formulaciones de anticuerpos.
JO3449B1 (ar) صيغ مستقرة تحتوي على الأجسام المضادة لمضاد عامل نمو الأعصاب
MY172245A (en) Subcutaneous anti-her2 antibody formulation
AU2009215514A9 (en) Composition comprising a combination of omeprazole and lansoprazole, and a buffering agent, and methods of using same
PH12014502460A1 (en) Lyophilised and aqueos anti-cd40 antibody formulations
PH12014502778B1 (en) Antibody formulation
HK1145803A1 (en) Devices, formulations, and methods for delivery of multiple beneficial agents
MX348823B (es) Formulaciones estables de linaclotida.
TN2009000382A1 (en) Stable antibody formulations
MY159156A (en) Antibody formulation
MX339624B (es) Composiciones mejoradas de celulas y metodos para preparar las mismas.
MX344795B (es) Composiciones y metodos para suministro al sistema nervioso central de arilsulfatasa a.
WO2010053610A3 (en) Stable anthrax vaccine formulations
SG170758A1 (en) Alkoxylated alkylamines or alkyl ether amines with peaked distribution
MY182793A (en) Stable and soluble formulations of receptor tyrosine kinase inhibitors, and methods of preparation thereof
UA103025C2 (ru) Твердая композиция лекарственного средства замедленного высвобождения
WO2011163651A3 (en) METHODS AND COMPOSITIONS FOR CNS DELIVERY OF β-GALACTOCEREBROSIDASE
WO2011069076A3 (en) Sustained release donepezil formulations
WO2011002422A3 (en) Solubility enhancing pharmaceutical formulation
MX2007013327A (es) Formulaciones de liberacion prolongada.
WO2011029102A3 (en) Cd117+cells and uses thereof
EP2611799A4 (en) PHARMACEUTICAL COMPOSITIONS OF LINEZOLID
MX2008002272A (es) Compuestos de ciclopropilo y composiciones para suministrar agentes activos.
MX366768B (es) Tableta orodispersable de sildenafil y metodo para preparar la misma.
高蕾 et al. Human umbilical cord blood-derived stromal cells: multifaceted regulators of megakaryocytopoiesis

Legal Events

Date Code Title Description
FG Grant or registration