PL3721904T3 - Formulacje przeciwciała t1h - Google Patents

Formulacje przeciwciała t1h

Info

Publication number
PL3721904T3
PL3721904T3 PL20174783T PL20174783T PL3721904T3 PL 3721904 T3 PL3721904 T3 PL 3721904T3 PL 20174783 T PL20174783 T PL 20174783T PL 20174783 T PL20174783 T PL 20174783T PL 3721904 T3 PL3721904 T3 PL 3721904T3
Authority
PL
Poland
Prior art keywords
antibody
formulations
Prior art date
Application number
PL20174783T
Other languages
English (en)
Inventor
Karthik Ramani
Sucharitha Jayakar
Original Assignee
Biocon Limited
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 Limited filed Critical Biocon Limited
Publication of PL3721904T3 publication Critical patent/PL3721904T3/pl

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 [IGs], 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)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Mycology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Organic Chemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
PL20174783T 2009-11-20 2010-11-19 Formulacje przeciwciała t1h PL3721904T3 (pl)

Applications Claiming Priority (4)

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
EP20174783.9A EP3721904B1 (en) 2009-11-20 2010-11-19 Formulations of t1h antibody
EP10831248.9A EP2501408B1 (en) 2009-11-20 2010-11-19 Formulations of antibody

Publications (1)

Publication Number Publication Date
PL3721904T3 true PL3721904T3 (pl) 2022-01-31

Family

ID=44059267

Family Applications (1)

Application Number Title Priority Date Filing Date
PL20174783T PL3721904T3 (pl) 2009-11-20 2010-11-19 Formulacje przeciwciała t1h

Country Status (20)

Country Link
US (4) US20120231009A1 (pl)
EP (2) EP3721904B1 (pl)
JP (2) JP5896471B2 (pl)
KR (1) KR101333276B1 (pl)
CN (1) CN102770157B (pl)
AU (1) AU2010320515B2 (pl)
BR (1) BR112012012080B1 (pl)
CA (1) CA2781467C (pl)
CU (1) CU20120080A7 (pl)
DK (1) DK3721904T3 (pl)
ES (1) ES2897500T3 (pl)
IL (1) IL219884A (pl)
MX (1) MX2012005863A (pl)
MY (1) MY165614A (pl)
NZ (1) NZ600096A (pl)
PL (1) PL3721904T3 (pl)
PT (1) PT3721904T (pl)
RU (1) RU2548772C2 (pl)
WO (1) WO2011061712A1 (pl)
ZA (1) ZA201204459B (pl)

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EP2265644A4 (en) 2008-03-14 2011-04-27 Biocon Ltd MONOCLONAL ANTIBODY AND CORRESPONDING METHOD
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
CA2825838C (en) 2011-01-28 2020-10-27 Sanofi Human antibodies to pcsk9 for use in methods of treating particular groups of subjects
AR087305A1 (es) 2011-07-28 2014-03-12 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit
ES2773111T3 (es) 2011-09-16 2020-07-09 Regeneron Pharma Inhibidor de la proproteína convertasa subtilisina/kexina 9 (PCSK9) para su uso en la reducción de los niveles de lipoproteína (a)
NZ627859A (en) 2012-01-23 2015-09-25 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
PT2916866T (pt) 2012-11-06 2018-07-10 Amgen Inc Formulação para ativadores de células t bispecíficas (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)
DK3024485T3 (da) 2013-07-23 2020-12-07 Biocon Ltd Anvendelse af en CD6-bindingspartner og fremgangsmåde baseret derpå
CN110496099B (zh) 2013-09-11 2022-06-21 伊戈尔生物药品股份有限公司 包含粘度降低剂的液体蛋白质制剂
CN118105480A (zh) 2013-11-12 2024-05-31 赛诺菲生物技术公司 用于与pcsk9抑制剂一起使用的给药方案
US10206878B2 (en) * 2014-05-28 2019-02-19 Nono Inc. Lyophilized formulation of TAT-NR2B9C with acetylation scavenger
EP3169353B1 (en) 2014-07-16 2019-12-18 Sanofi Biotechnology Methods for treating patients with heterozygous familial hypercholesterolemia (hefh)
MX2017004306A (es) 2014-10-01 2017-12-20 Eagle Biologics Inc Formulaciones de polisacáridos y ácido nucleico que contienen agentes de reducción de viscosidad.
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
KR20180034672A (ko) 2015-08-18 2018-04-04 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
US11071782B2 (en) 2016-04-20 2021-07-27 Coherus Biosciences, Inc. Method of filling a container with no headspace
AU2017333367A1 (en) * 2016-09-27 2019-04-04 Fresenius Kabi Deutschland Gmbh Liquid pharmaceutical composition
KR102514528B1 (ko) 2016-10-21 2023-03-27 바이오콘 리미티드 루푸스 치료를 위한 단일클론항체 및 이의 치료방법
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
AU2020225202B2 (en) 2019-02-18 2023-10-26 Eli Lilly And Company 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

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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
ES2477996T3 (es) 2000-08-11 2014-07-18 Chugai Seiyaku Kabushiki Kaisha Preparaciones estabilizadas que contienen un anticuerpo
ATE454137T1 (de) * 2001-07-25 2010-01-15 Facet Biotech Corp Stabile lyophilisierte pharmazeutische formulierung des igg-antikörpers daclizumab
EP1610820B2 (en) * 2003-04-04 2013-08-21 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
CA2654794A1 (en) * 2006-06-14 2007-12-21 Imclone Systems Incorporated 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
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Also Published As

Publication number Publication date
RU2012125254A (ru) 2013-12-27
KR20130028894A (ko) 2013-03-20
CN102770157A (zh) 2012-11-07
AU2010320515B2 (en) 2013-05-02
CU20120080A7 (es) 2012-10-15
EP3721904A1 (en) 2020-10-14
EP3721904B1 (en) 2021-10-13
JP5896471B2 (ja) 2016-03-30
US20120231009A1 (en) 2012-09-13
BR112012012080A2 (pl) 2021-11-03
PT3721904T (pt) 2021-11-15
BR112012012080B1 (pt) 2022-11-29
EP2501408A1 (en) 2012-09-26
US20190321285A1 (en) 2019-10-24
ES2897500T3 (es) 2022-03-01
EP2501408A4 (en) 2014-10-08
MX2012005863A (es) 2013-01-18
CN102770157B (zh) 2017-05-17
KR101333276B1 (ko) 2013-11-27
CA2781467C (en) 2015-10-13
ZA201204459B (en) 2013-02-27
DK3721904T3 (da) 2021-11-15
US20240058263A1 (en) 2024-02-22
JP2013511510A (ja) 2013-04-04
IL219884A0 (en) 2012-07-31
CA2781467A1 (en) 2011-05-26
JP2016104780A (ja) 2016-06-09
MY165614A (en) 2018-04-18
EP2501408B1 (en) 2020-05-27
US20210290525A1 (en) 2021-09-23
AU2010320515A1 (en) 2012-06-14
RU2548772C2 (ru) 2015-04-20
NZ600096A (en) 2013-08-30
IL219884A (en) 2015-11-30
WO2011061712A1 (en) 2011-05-26
ES2897500T8 (es) 2022-03-10

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