JP2024523443A - 高濃度凍結乾燥生物製剤の再構成時間を減少させるためのスクロース、マンニトールおよびグリシンの使用 - Google Patents

高濃度凍結乾燥生物製剤の再構成時間を減少させるためのスクロース、マンニトールおよびグリシンの使用 Download PDF

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Publication number
JP2024523443A
JP2024523443A JP2023578727A JP2023578727A JP2024523443A JP 2024523443 A JP2024523443 A JP 2024523443A JP 2023578727 A JP2023578727 A JP 2023578727A JP 2023578727 A JP2023578727 A JP 2023578727A JP 2024523443 A JP2024523443 A JP 2024523443A
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JP
Japan
Prior art keywords
activatable
unit dose
dose formulation
lyophilized
ipilimumab
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
JP2023578727A
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English (en)
Japanese (ja)
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JPWO2022271544A5 (https=
JP2024523443A5 (https=
Inventor
シン ビンドラ，ディルバー
ジェイ ディア，バートン
フー，ユエ
シエラ， イスマーエール モンダル
トゥカラム モア，ハレシュ
パン，ドゥオハイ
ウー，ヨンメイ
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bristol Myers Squibb Co
Original Assignee
Bristol Myers Squibb Co
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 Bristol Myers Squibb Co filed Critical Bristol Myers Squibb Co
Publication of JP2024523443A publication Critical patent/JP2024523443A/ja
Publication of JPWO2022271544A5 publication Critical patent/JPWO2022271544A5/ja
Publication of JP2024523443A5 publication Critical patent/JP2024523443A5/ja
Pending legal-status Critical Current

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Classifications

    • 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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2818—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against CD28 or CD152
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/74—Inducing cell proliferation
    • 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
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/50—Fusion polypeptide containing protease site

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)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Endocrinology (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
JP2023578727A 2021-06-21 2022-06-17 高濃度凍結乾燥生物製剤の再構成時間を減少させるためのスクロース、マンニトールおよびグリシンの使用 Pending JP2024523443A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202163213026P 2021-06-21 2021-06-21
US63/213,026 2021-06-21
PCT/US2022/033958 WO2022271544A1 (en) 2021-06-21 2022-06-17 Use of sucrose, mannitol and glycine to reduce reconstitution time of high concentration lyophilized biologics drug products

Publications (3)

Publication Number Publication Date
JP2024523443A true JP2024523443A (ja) 2024-06-28
JPWO2022271544A5 JPWO2022271544A5 (https=) 2025-06-18
JP2024523443A5 JP2024523443A5 (https=) 2025-06-18

Family

ID=82403446

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2023578727A Pending JP2024523443A (ja) 2021-06-21 2022-06-17 高濃度凍結乾燥生物製剤の再構成時間を減少させるためのスクロース、マンニトールおよびグリシンの使用

Country Status (6)

Country Link
US (1) US20250332251A1 (https=)
EP (1) EP4359438A1 (https=)
JP (1) JP2024523443A (https=)
KR (1) KR20240024929A (https=)
CN (1) CN117500834A (https=)
WO (1) WO2022271544A1 (https=)

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2454587C (en) * 2001-07-25 2012-11-13 Protein Design Labs, Inc. Stable lyophilized pharmaceutical formulation of igg antibodies
AU2003293543A1 (en) * 2002-12-13 2004-07-09 Abgenix, Inc. System and method for stabilizing antibodies with histidine
US20120121580A1 (en) * 2009-07-28 2012-05-17 Merck Sharp & Dohme Corp. Methods for producing high concentration lyophilized pharmaceutical formulations
MX362591B (es) * 2010-11-05 2019-01-25 Novartis Ag Uso de antagonistas de il-17.
US20190060241A1 (en) * 2016-04-13 2019-02-28 Medimmune, Llc Use of amino acids as stabilizing compounds in pharmaceutical compositions containing high concentrations of protein-based therapeutic agents
MX2019004775A (es) 2016-11-03 2019-08-05 Squibb Bristol Myers Co Anticuerpos anti antigeno 4 del linfocito t citotoxico (ctla-4) activables y sus usos.
JOP20190260A1 (ar) * 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
GB201718888D0 (en) * 2017-11-15 2017-12-27 Ucb Biopharma Sprl Method
TWI897855B (zh) * 2018-10-26 2025-09-21 美商免疫遺傳股份有限公司 Ｅ ｐ Ｃ Ａ Ｍ 抗體、可活化抗體及免疫偶聯物以及其用途
US20220233709A1 (en) * 2019-06-05 2022-07-28 Seagen Inc. Masked Antibody Formulations

Also Published As

Publication number Publication date
CN117500834A (zh) 2024-02-02
EP4359438A1 (en) 2024-05-01
US20250332251A1 (en) 2025-10-30
WO2022271544A1 (en) 2022-12-29
KR20240024929A (ko) 2024-02-26

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