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
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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (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 (en) 2015-02-13 2016-02-12 Stable liquid formulation for monoclonal antibodies

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

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US9458450B2 (en) 2012-03-15 2016-10-04 Flodesign Sonics, Inc. Acoustophoretic separation technology using multi-dimensional standing waves
US10704021B2 (en) 2012-03-15 2020-07-07 Flodesign Sonics, Inc. Acoustic perfusion devices
US9950282B2 (en) 2012-03-15 2018-04-24 Flodesign Sonics, Inc. Electronic configuration and control for acoustic standing wave generation
US10967298B2 (en) 2012-03-15 2021-04-06 Flodesign Sonics, Inc. Driver and control for variable impedence load
WO2015105955A1 (en) 2014-01-08 2015-07-16 Flodesign Sonics, Inc. Acoustophoresis device with dual acoustophoretic chamber
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
US11459540B2 (en) 2015-07-28 2022-10-04 Flodesign Sonics, Inc. Expanded bed affinity selection
US11474085B2 (en) 2015-07-28 2022-10-18 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
PT3479819T (en) 2016-06-30 2024-04-15 Celltrion Inc Stable liquid pharmaceutical preparation
CA3041517A1 (en) 2016-10-19 2018-04-26 Flodesign Sonics, Inc. Affinity cell extraction by acoustics
MA47106A (en) * 2016-12-21 2019-10-30 Amgen Inc ANTI-TNF ALPHA ANTIBODY FORMULATIONS
WO2018131893A1 (en) 2017-01-11 2018-07-19 ㈜셀트리온 Stable liquid formula
CN108686204A (en) * 2017-04-07 2018-10-23 浙江海正药业股份有限公司 Include the infliximab composition of histidine buffer system
JP2021507561A (en) 2017-12-14 2021-02-22 フロデザイン ソニックス, インク.Flodesign Sonics, Inc. Acoustic Transducer Driver and Controller
CN110092831B (en) * 2018-01-30 2022-05-20 北京睿诚海汇健康科技有限公司 Application of plant as host in expressing adalimus antibody
CN109266620B (en) * 2018-09-04 2023-01-10 四川安可瑞新材料技术有限公司 Anti-human IgG monoclonal antibody, hybridoma cell strain and application thereof
CN109280644B (en) * 2018-09-04 2023-02-17 四川安可瑞新材料技术有限公司 Anti-human IgG monoclonal antibody, hybridoma cell strain and application thereof
CN109112113B (en) * 2018-09-05 2023-01-10 四川安可瑞新材料技术有限公司 Anti-human IgG monoclonal antibody, hybridoma cell strain, kit and application thereof
CN109082413B (en) * 2018-09-18 2023-01-10 四川安可瑞新材料技术有限公司 Anti-human IgG monoclonal antibody, hybridoma cell strain and application thereof
CN109112114B (en) * 2018-09-18 2023-02-17 四川安可瑞新材料技术有限公司 Anti-human IgG monoclonal antibody, hybridoma cell strain and application thereof
AU2020225202B2 (en) 2019-02-18 2023-10-26 Eli Lilly And Company Therapeutic antibody formulation
WO2020185479A1 (en) 2019-03-08 2020-09-17 Boehringer Ingelheim International Gmbh Anti-il-36r antibody formulations
CN111686247B (en) * 2019-03-13 2022-07-29 苏州康乃德生物医药有限公司 Liquid compositions comprising antibodies to human interleukin-4 receptor alpha
RU2754760C2 (en) * 2019-04-02 2021-09-07 Закрытое Акционерное Общество "Биокад" Aqueous pharmaceutical composition of anti-il17a antibody and its application
US20230115267A1 (en) * 2020-03-13 2023-04-13 Samsung Bioepis Co., Ltd. Pharmaceutical liquid composition having increased stability
EP4151233A1 (en) * 2020-05-13 2023-03-22 Innovent Biologics (Suzhou) Co., Ltd. Preparation comprising anti-il-23p19 antibody, preparation method therefor and use thereof
JP7057954B2 (en) * 2020-09-03 2022-04-21 国立大学法人大阪大学 Protein-containing liquid formulation with improved storage stability

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JO3000B1 (en) * 2004-10-20 2016-09-05 Genentech Inc Antibody Formulations.
ES2784861T3 (en) * 2012-09-07 2020-10-01 Coherus Biosciences Inc Stable aqueous formulations of adalimumab

Also Published As

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

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