AU2020337093B2 - Novel formulation of highly concentrated pharmacologically active antibody - Google Patents

Novel formulation of highly concentrated pharmacologically active antibody Download PDF

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Publication number
AU2020337093B2
AU2020337093B2 AU2020337093A AU2020337093A AU2020337093B2 AU 2020337093 B2 AU2020337093 B2 AU 2020337093B2 AU 2020337093 A AU2020337093 A AU 2020337093A AU 2020337093 A AU2020337093 A AU 2020337093A AU 2020337093 B2 AU2020337093 B2 AU 2020337093B2
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AU
Australia
Prior art keywords
pharmaceutical
formulation
present
antibody
formulation according
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Active
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AU2020337093A
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English (en)
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AU2020337093A1 (en
Inventor
Om NARAYAN
Sumit Maheshkumar SHAH
Bruce WEAVER
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Kashiv Biosciences LLC
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Kashiv Biosciences LLC
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Publication of AU2020337093A1 publication Critical patent/AU2020337093A1/en
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/42—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against immunoglobulins
    • C07K16/4283—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an allotypic or isotypic determinant on Ig
    • C07K16/4291—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an allotypic or isotypic determinant on Ig against IgE
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
AU2020337093A 2019-08-30 2020-08-29 Novel formulation of highly concentrated pharmacologically active antibody Active AU2020337093B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN201921035059 2019-08-30
IN201921035059 2019-08-30
PCT/IB2020/058080 WO2021038532A1 (en) 2019-08-30 2020-08-29 Novel formulation of highly concentrated pharmacologically active antibody

Publications (2)

Publication Number Publication Date
AU2020337093A1 AU2020337093A1 (en) 2022-04-21
AU2020337093B2 true AU2020337093B2 (en) 2025-02-27

Family

ID=74684124

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2020337093A Active AU2020337093B2 (en) 2019-08-30 2020-08-29 Novel formulation of highly concentrated pharmacologically active antibody

Country Status (6)

Country Link
US (2) US20220267473A1 (https=)
EP (1) EP4021497B1 (https=)
JP (1) JP7792137B2 (https=)
AU (1) AU2020337093B2 (https=)
CA (1) CA3152838A1 (https=)
WO (1) WO2021038532A1 (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2021262609A1 (en) 2020-05-01 2022-12-22 Kashiv Biosciences, Llc An improved process of purification of protein
CA3237624A1 (en) * 2023-07-28 2025-04-24 Genentech, Inc. NEW USES FOR OMALIZUMAB

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040197324A1 (en) * 2003-04-04 2004-10-07 Genentech, Inc. High concentration antibody and protein formulations
EP2116265A2 (en) * 2000-10-12 2009-11-11 Genentech, Inc. Reduced-viscosity concentrated protein formulations
WO2013096791A1 (en) * 2011-12-23 2013-06-27 Genentech, Inc. Process for making high concentration protein formulations

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8703126B2 (en) 2000-10-12 2014-04-22 Genentech, Inc. Reduced-viscosity concentrated protein formulations
NZ595526A (en) 2007-06-14 2013-03-28 Biogen Idec Inc Pharmaceutical composition comprising a vla-4 binding antibody, a phosphate buffer and a surfactant
PT3345593T (pt) * 2009-11-13 2023-11-27 Sanofi Aventis Deutschland Composição farmacêutica compreendendo despro36exendina- 4(1-39)-lys6-nh2 e metionina
JP2015509526A (ja) 2012-03-07 2015-03-30 カディラ ヘルスケア リミティド 医薬製剤
PE20150964A1 (es) * 2012-09-07 2015-07-25 Coherus Biosciences Inc Formulaciones acuosas estables de adalimumab
JP2016515120A (ja) 2013-03-15 2016-05-26 バイオジェン・エムエイ・インコーポレイテッドＢｉｏｇｅｎ ＭＡ Ｉｎｃ． 抗アルファｖベータ５抗体を用いた急性腎損傷の治療及び予防
RS57864B1 (sr) * 2013-06-17 2018-12-31 De Staat Der Nederlanden Vert Door De Minister Van Vws Ministerie Van Volksgezondheid Welzijn En Spo Postupci za sprečavanje agregacije virusnih komponenti
WO2016109822A1 (en) 2014-12-31 2016-07-07 Novelmed Therapeutics, Inc. Formulation of aglycosylated therapeutic antibodies
SG10202012778YA (en) 2015-12-18 2021-01-28 Astellas Pharma Inc Pharmaceutical composition comprising anti-human tslp receptor antibody
EP3443346B1 (en) * 2016-04-13 2023-08-30 Medimmune, LLC Use of amino acids as stabilizing compounds in pharmaceutical compositions containing high concentrations of protein-based therapeutic agents
US10646569B2 (en) * 2017-05-16 2020-05-12 Bhami's Research Laboratory, Pvt. Ltd. High concentration protein formulations with reduced viscosity
DK3658184T5 (da) 2017-07-27 2024-08-26 Alexion Pharma Inc Højkoncentrerede anti-c5-antistofformuleringer

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2116265A2 (en) * 2000-10-12 2009-11-11 Genentech, Inc. Reduced-viscosity concentrated protein formulations
US20040197324A1 (en) * 2003-04-04 2004-10-07 Genentech, Inc. High concentration antibody and protein formulations
WO2013096791A1 (en) * 2011-12-23 2013-06-27 Genentech, Inc. Process for making high concentration protein formulations

Also Published As

Publication number Publication date
US20250043027A1 (en) 2025-02-06
WO2021038532A1 (en) 2021-03-04
JP7792137B2 (ja) 2025-12-25
US20220267473A1 (en) 2022-08-25
EP4021497A1 (en) 2022-07-06
EP4021497B1 (en) 2026-02-25
JP2022546400A (ja) 2022-11-04
CA3152838A1 (en) 2021-03-04
AU2020337093A1 (en) 2022-04-21
EP4021497A4 (en) 2023-09-06

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