MY165614A - Formulations of antibody - Google Patents

Formulations of antibody

Info

Publication number
MY165614A
MY165614A MYPI2012002248A MYPI2012002248A MY165614A MY 165614 A MY165614 A MY 165614A MY PI2012002248 A MYPI2012002248 A MY PI2012002248A MY PI2012002248 A MYPI2012002248 A MY PI2012002248A MY 165614 A MY165614 A MY 165614A
Authority
MY
Malaysia
Prior art keywords
formulations
antibody
lyoprotectants
cryoprotectants
buffer
Prior art date
Application number
MYPI2012002248A
Other languages
English (en)
Inventor
Karthik Ramani
Sucharitha Jayakar
Original Assignee
Biocon Ltd
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 filed Critical Biocon Ltd
Publication of MY165614A publication Critical patent/MY165614A/en

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)
  • 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)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
MYPI2012002248A 2009-11-20 2010-11-19 Formulations of antibody MY165614A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IN2859CH2009 2009-11-20

Publications (1)

Publication Number Publication Date
MY165614A true MY165614A (en) 2018-04-18

Family

ID=44059267

Family Applications (1)

Application Number Title Priority Date Filing Date
MYPI2012002248A MY165614A (en) 2009-11-20 2010-11-19 Formulations of antibody

Country Status (20)

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

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DK2993186T3 (da) 2008-03-14 2019-11-25 Biocon Ltd En monoklonal antistof og en fremgangsmåde hertil
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
AR084937A1 (es) 2011-01-28 2013-07-10 Sanofi Sa Anticuerpos humanos frente a pcsk9 para uso en metodos de tratamiento basados en regimenes de dosificacion particulares
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
WO2013112438A1 (en) 2012-01-23 2013-08-01 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
EA029215B1 (ru) 2012-09-07 2018-02-28 Кохерус Байосайенсис, Инк. Стабильные водные составы адалимумаба
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
LT2916866T (lt) 2012-11-06 2018-07-25 Bayer Pharma Aktiengesellschaft Bispecifinių t ląstelių aktyvatorių (bites) kompozicija
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)
AU2014294616B2 (en) 2013-07-23 2019-07-11 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
MX2016006226A (es) 2013-11-12 2016-09-07 Sanofi Biotechnology Regimenes de dosificacion para uso con inhibidores de pcsk9.
US10206878B2 (en) * 2014-05-28 2019-02-19 Nono Inc. Lyophilized formulation of TAT-NR2B9C with acetylation scavenger
RU2735521C2 (ru) 2014-07-16 2020-11-03 Санофи Байотекнолоджи Способы лечения пациентов с гетерозиготной семейной гиперхолестеринемией (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
EA201890519A1 (ru) 2015-08-18 2018-07-31 Ридженерон Фармасьютикалз, Инк. Ингибирующие антитела против pcsk9 для лечения пациентов с гиперлипидемией, подвергающихся аферезу липопротеинов
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
WO2018060210A1 (en) * 2016-09-27 2018-04-05 Ares Trading S.A. Liquid pharmaceutical composition
WO2018073734A1 (en) 2016-10-21 2018-04-26 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
MX2020009935A (es) * 2018-03-23 2021-01-08 Abbvie Deutschland Formulaciones acuosas y estables de anticuerpos anti-tau.
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
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

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AU2001277781A1 (en) 2000-08-11 2002-02-25 Chugai Seiyaku Kabushiki Kaisha Stabilized antibody-containing preparations
ATE454137T1 (de) * 2001-07-25 2010-01-15 Facet Biotech Corp Stabile lyophilisierte pharmazeutische formulierung des igg-antikörpers daclizumab
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
EP3037544A1 (en) * 2005-10-13 2016-06-29 Human Genome Sciences, Inc. Methods and compositions for use in treatment of systemic lupus erythematosus (sle) patients with autoantibody positive diseases
AU2007260769A1 (en) * 2006-06-14 2007-12-21 Imclone Llc Lyophilized formulations of anti-EGFR antibodies
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Also Published As

Publication number Publication date
US20190321285A1 (en) 2019-10-24
BR112012012080B1 (pt) 2022-11-29
CA2781467C (en) 2015-10-13
ES2897500T8 (es) 2022-03-10
IL219884A0 (en) 2012-07-31
ZA201204459B (en) 2013-02-27
RU2548772C2 (ru) 2015-04-20
WO2011061712A1 (en) 2011-05-26
EP3721904B1 (en) 2021-10-13
CN102770157B (zh) 2017-05-17
US20240058263A1 (en) 2024-02-22
NZ600096A (en) 2013-08-30
JP5896471B2 (ja) 2016-03-30
EP2501408A1 (en) 2012-09-26
EP3721904A1 (en) 2020-10-14
PL3721904T3 (pl) 2022-01-31
US20120231009A1 (en) 2012-09-13
ES2897500T3 (es) 2022-03-01
AU2010320515A1 (en) 2012-06-14
EP2501408A4 (en) 2014-10-08
AU2010320515B2 (en) 2013-05-02
IL219884A (en) 2015-11-30
DK3721904T3 (da) 2021-11-15
KR20130028894A (ko) 2013-03-20
KR101333276B1 (ko) 2013-11-27
CA2781467A1 (en) 2011-05-26
EP2501408B1 (en) 2020-05-27
BR112012012080A2 (OSRAM) 2021-11-03
PT3721904T (pt) 2021-11-15
US20210290525A1 (en) 2021-09-23
CN102770157A (zh) 2012-11-07
JP2013511510A (ja) 2013-04-04
RU2012125254A (ru) 2013-12-27
CU20120080A7 (es) 2012-10-15
MX2012005863A (es) 2013-01-18
JP2016104780A (ja) 2016-06-09

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