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)
Polish (pl)
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)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Mycology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Microbiology (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 (en, 2012)
EP (2) EP3721904B1 (en, 2012)
JP (2) JP5896471B2 (en, 2012)
KR (1) KR101333276B1 (en, 2012)
CN (1) CN102770157B (en, 2012)
AU (1) AU2010320515B2 (en, 2012)
BR (1) BR112012012080B1 (en, 2012)
CA (1) CA2781467C (en, 2012)
CU (1) CU20120080A7 (en, 2012)
DK (1) DK3721904T3 (en, 2012)
ES (1) ES2897500T3 (en, 2012)
IL (1) IL219884A (en, 2012)
MX (1) MX2012005863A (en, 2012)
MY (1) MY165614A (en, 2012)
NZ (1) NZ600096A (en, 2012)
PL (1) PL3721904T3 (en, 2012)
PT (1) PT3721904T (en, 2012)
RU (1) RU2548772C2 (en, 2012)
WO (1) WO2011061712A1 (en, 2012)
ZA (1) ZA201204459B (en, 2012)

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JOP20080381B1 (ar) 2007-08-23 2023-03-28 Amgen Inc بروتينات مرتبطة بمولدات مضادات تتفاعل مع بروبروتين كونفيرتاز سيتيليزين ككسين من النوع 9 (pcsk9)
MX2010010085A (es) 2008-03-14 2011-03-29 Biocon Ltd Un anticuerpo monoclonal y el metodo para su uso.
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).
EP3326648B1 (en) 2011-01-28 2021-03-10 Sanofi Biotechnology 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
AU2012308797B2 (en) 2011-09-16 2017-06-01 Regeneron Pharmaceuticals, Inc. Methods for reducing lipoprotein(a) levels by administering an inhibitor of proprotein convertase subtilisin kexin-9 (PSCK9)
MX357393B (es) 2012-01-23 2018-07-06 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti - ang2.
AR092325A1 (es) 2012-05-31 2015-04-15 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-dll4 y kit
SG10201705668XA (en) 2012-09-07 2017-08-30 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
TR201809507T4 (tr) 2012-11-06 2018-07-23 Bayer Pharma AG Bispesifik T-hücresi bağlayıcıları (BİTE'ler) için formülasyon.
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)
US10189899B2 (en) 2013-07-23 2019-01-29 Biocon Limited Use of a CD6 binding partner and method based thereon
IL312865B2 (en) 2013-09-11 2025-06-01 Eagle Biologics Inc Liquid protein formulations containing viscosity-lowering agents
TWI670077B (zh) 2013-11-12 2019-09-01 賽諾菲生物技術公司 使用pcsk9抑制劑之給藥療程
JP6707469B2 (ja) * 2014-05-28 2020-06-10 ノノ インコーポレイテッド アセチル化スカベンジャーを含むTat−NR2B9cの凍結乾燥製剤
CA2955294A1 (en) 2014-07-16 2016-01-21 Sanofi Biotechnology Methods for treating patients with heterozygous familial hypercholesterolemia (hefh)
AU2015325055B2 (en) 2014-10-01 2021-02-25 Eagle Biologics, 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
EP3337828B1 (en) 2015-08-18 2025-08-27 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
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
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
EP3768706A1 (en) * 2018-03-23 2021-01-27 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
TW202417512A (zh) * 2022-10-17 2024-05-01 英屬開曼群島商百濟神州有限公司 含有抗tigit抗體的配製物及其使用方法
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

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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
EP2311492B1 (en) 2000-08-11 2017-10-04 Chugai Seiyaku Kabushiki Kaisha Antibody-containing stabilized preparations
DE60235013D1 (de) * 2001-07-25 2010-02-25 Facet Biotech Corp Stabile lyophilisierte pharmazeutische formulierung des igg-antikörpers daclizumab
MXPA05010555A (es) * 2003-04-04 2006-03-09 Genentech Inc Formulaciones de proteina y anticuerpo de alta concentracion.
EP1933873A4 (en) * 2005-10-13 2009-12-02 Human Genome Sciences Inc METHODS AND COMPOSITIONS FOR THE TREATMENT OF PATIENTS WITH POSITIVE DISEASES FOR SELF-ANTIBODIES
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PT2119453E (pt) * 2006-12-26 2015-09-01 Ct De Inmunolgã A Molecular Composições farmacêuticas capazes de induzir apoptose em células tumorais, úteis para o diagnóstico e o tratamento da leucemia linfocítica crónica de células
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Also Published As

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

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