SG11201706505PA - Stable liquid formulation for monoclonal antibodies - Google Patents

Stable liquid formulation for monoclonal antibodies

Info

Publication number
SG11201706505PA
SG11201706505PA SG11201706505PA SG11201706505PA SG11201706505PA SG 11201706505P A SG11201706505P A SG 11201706505PA SG 11201706505P A SG11201706505P A SG 11201706505PA SG 11201706505P A SG11201706505P A SG 11201706505PA SG 11201706505P A SG11201706505P A SG 11201706505PA
Authority
SG
Singapore
Prior art keywords
monoclonal antibodies
liquid formulation
stable liquid
stable
formulation
Prior art date
Application number
SG11201706505PA
Other languages
English (en)
Inventor
Till Bussemer
Annette Pieper
Dijana Sagi
Nina Strebe
Ahmed Yousseff
Original Assignee
Sanofi Sa
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 Sanofi Sa filed Critical Sanofi Sa
Publication of SG11201706505PA publication Critical patent/SG11201706505PA/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
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K9/0012Galenical 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241Tumor Necrosis Factors
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

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)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Rheumatology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
SG11201706505PA 2015-02-13 2016-02-12 Stable liquid formulation for monoclonal antibodies SG11201706505PA (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP15305218 2015-02-13
PCT/EP2016/053068 WO2016128564A1 (fr) 2015-02-13 2016-02-12 Formulation liquide stable pour des anticorps monoclonaux

Publications (1)

Publication Number Publication Date
SG11201706505PA true SG11201706505PA (en) 2017-09-28

Family

ID=52589319

Family Applications (1)

Application Number Title Priority Date Filing Date
SG11201706505PA SG11201706505PA (en) 2015-02-13 2016-02-12 Stable liquid formulation for monoclonal antibodies

Country Status (13)

Country Link
US (1) US20180008707A1 (fr)
EP (1) EP3256160A1 (fr)
JP (1) JP2018507202A (fr)
KR (1) KR20170117166A (fr)
CN (1) CN107635581A (fr)
AU (1) AU2016217806A1 (fr)
BR (1) BR112017016636A2 (fr)
CA (1) CA2976298A1 (fr)
MX (1) MX2017010400A (fr)
RU (1) RU2017131618A (fr)
SG (1) SG11201706505PA (fr)
TW (1) TW201632203A (fr)
WO (1) WO2016128564A1 (fr)

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US9950282B2 (en) 2012-03-15 2018-04-24 Flodesign Sonics, Inc. Electronic configuration and control for acoustic standing wave generation
US9458450B2 (en) 2012-03-15 2016-10-04 Flodesign Sonics, Inc. Acoustophoretic separation technology using multi-dimensional standing waves
US10967298B2 (en) 2012-03-15 2021-04-06 Flodesign Sonics, Inc. Driver and control for variable impedence load
US10704021B2 (en) 2012-03-15 2020-07-07 Flodesign Sonics, Inc. Acoustic perfusion devices
US9725710B2 (en) 2014-01-08 2017-08-08 Flodesign Sonics, Inc. Acoustophoresis device with dual acoustophoretic chamber
US11420136B2 (en) 2016-10-19 2022-08-23 Flodesign Sonics, Inc. Affinity cell extraction by acoustics
US11708572B2 (en) 2015-04-29 2023-07-25 Flodesign Sonics, Inc. Acoustic cell separation techniques and processes
US11021699B2 (en) 2015-04-29 2021-06-01 FioDesign Sonics, Inc. Separation using angled acoustic waves
US11377651B2 (en) 2016-10-19 2022-07-05 Flodesign Sonics, Inc. Cell therapy processes utilizing acoustophoresis
US11474085B2 (en) 2015-07-28 2022-10-18 Flodesign Sonics, Inc. Expanded bed affinity selection
US11459540B2 (en) 2015-07-28 2022-10-04 Flodesign Sonics, Inc. Expanded bed affinity selection
US11085035B2 (en) 2016-05-03 2021-08-10 Flodesign Sonics, Inc. Therapeutic cell washing, concentration, and separation utilizing acoustophoresis
US11214789B2 (en) 2016-05-03 2022-01-04 Flodesign Sonics, Inc. Concentration and washing of particles with acoustics
SG11201811320YA (en) * 2016-06-30 2019-01-30 Celltrion Inc Stable liquid pharmaceutical preparation
EP3558363A1 (fr) * 2016-12-21 2019-10-30 Amgen Inc. Formulations d'anticorps anti-tnf alpha
EP3569224B1 (fr) * 2017-01-11 2022-12-14 Celltrion Inc. Formule liquide stable
CN108686204A (zh) * 2017-04-07 2018-10-23 浙江海正药业股份有限公司 包含组氨酸缓冲体系的英夫利西单抗组合物
KR102439221B1 (ko) 2017-12-14 2022-09-01 프로디자인 소닉스, 인크. 음향 트랜스듀서 구동기 및 제어기
CN110092831B (zh) * 2018-01-30 2022-05-20 北京睿诚海汇健康科技有限公司 植物作为宿主在表达阿达木抗体中的应用
CN109280644B (zh) * 2018-09-04 2023-02-17 四川安可瑞新材料技术有限公司 抗人IgG单克隆抗体、其杂交瘤细胞株及应用
CN109266620B (zh) * 2018-09-04 2023-01-10 四川安可瑞新材料技术有限公司 抗人IgG单克隆抗体、其杂交瘤细胞株及应用
CN109112113B (zh) * 2018-09-05 2023-01-10 四川安可瑞新材料技术有限公司 抗人IgG的单克隆抗体、杂交瘤细胞株、试剂盒及其应用
CN109082413B (zh) * 2018-09-18 2023-01-10 四川安可瑞新材料技术有限公司 抗人IgG单克隆抗体、其杂交瘤细胞株及应用
CN109112114B (zh) * 2018-09-18 2023-02-17 四川安可瑞新材料技术有限公司 抗人IgG单克隆抗体、其杂交瘤细胞株及应用
KR20210096559A (ko) 2018-11-27 2021-08-05 이노벤트 바이오로직스 (쑤저우) 컴퍼니, 리미티드 항IL-23p19 항체 및 이의 용도
CN113474360A (zh) 2019-02-18 2021-10-01 伊莱利利公司 治疗性抗体制剂
MX2021010783A (es) 2019-03-08 2021-09-30 Boehringer Ingelheim Int Formulaciones de anticuerpo anti-il-36r.
CN111686247B (zh) * 2019-03-13 2022-07-29 苏州康乃德生物医药有限公司 包含人白介素-4受体α的抗体的液体组合物
RU2754760C2 (ru) * 2019-04-02 2021-09-07 Закрытое Акционерное Общество "Биокад" Водная фармацевтическая композиция анти-il17a антитела и ее применение
EP4119161A4 (fr) * 2020-03-13 2024-05-15 Samsung Bioepis Co., Ltd. Composition pharmaceutique liquide présentant une stabilité améliorée
TWI802882B (zh) * 2020-05-13 2023-05-21 大陸商信達生物制藥(蘇州)有限公司 包含抗IL-23p19抗體的製劑、其製備方法和用途
JP7057954B2 (ja) * 2020-09-03 2022-04-21 国立大学法人大阪大学 改善された保存安定性を有するタンパク質含有液体製剤

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JO3000B1 (ar) * 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
EA201791717A1 (ru) * 2012-09-07 2018-03-30 Кохерус Байосайенсис, Инк. Стабильные водные составы адалимумаба

Also Published As

Publication number Publication date
CA2976298A1 (fr) 2016-08-18
CN107635581A (zh) 2018-01-26
WO2016128564A1 (fr) 2016-08-18
RU2017131618A (ru) 2019-03-13
US20180008707A1 (en) 2018-01-11
JP2018507202A (ja) 2018-03-15
KR20170117166A (ko) 2017-10-20
BR112017016636A2 (pt) 2018-04-03
TW201632203A (zh) 2016-09-16
MX2017010400A (es) 2017-11-28
EP3256160A1 (fr) 2017-12-20
AU2016217806A1 (en) 2017-10-05

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