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

Info

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
Authority
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
Other languages
English (en)
Japanese (ja)
Other versions
JP2024523443A5 (cg-RX-API-DMAC10.html
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 JP2024523443A5 publication Critical patent/JP2024523443A5/ja
Pending legal-status Critical Current

Links

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)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (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 (2)

Publication Number Publication Date
JP2024523443A true JP2024523443A (ja) 2024-06-28
JP2024523443A5 JP2024523443A5 (cg-RX-API-DMAC10.html) 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 (cg-RX-API-DMAC10.html)
EP (1) EP4359438A1 (cg-RX-API-DMAC10.html)
JP (1) JP2024523443A (cg-RX-API-DMAC10.html)
KR (1) KR20240024929A (cg-RX-API-DMAC10.html)
CN (1) CN117500834A (cg-RX-API-DMAC10.html)
WO (1) WO2022271544A1 (cg-RX-API-DMAC10.html)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0654897A (ja) * 1992-08-08 1994-03-01 Chemo Sero Therapeut Res Inst フィブリノーゲン含有製剤
JP2004538287A (ja) * 2001-07-25 2004-12-24 プロテイン デザイン ラブス インコーポレイティド ＩｇＧ抗体の安定な凍結乾燥医薬製剤
JP2012056960A (ja) * 2002-01-18 2012-03-22 Asahi Kasei Pharma Kk 可溶性トロンボモジュリン含有製剤
US20120121580A1 (en) * 2009-07-28 2012-05-17 Merck Sharp & Dohme Corp. Methods for producing high concentration lyophilized pharmaceutical formulations
JP2020500016A (ja) * 2016-11-03 2020-01-09 ブリストル−マイヤーズ スクイブ カンパニーＢｒｉｓｔｏｌ−Ｍｙｅｒｓ Ｓｑｕｉｂｂ Ｃｏｍｐａｎｙ 活性化可能な抗ｃｔｌａ−４抗体およびその使用

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2003293543A1 (en) * 2002-12-13 2004-07-09 Abgenix, Inc. System and method for stabilizing antibodies with histidine
AU2011325134B2 (en) * 2010-11-05 2014-10-23 Novartis Ag Methods of treating rheumatoid arthritis using IL-17 antagonists
ES2962373T3 (es) * 2016-04-13 2024-03-18 Medimmune Llc Uso de aminoácidos como compuestos estabilizadores en composiciones farmacéuticas que contienen altas concentraciones de agentes terapéuticos basados en proteínas
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
TW202112354A (zh) * 2019-06-05 2021-04-01 美商西雅圖遺傳學公司 遮蔽抗體調配物

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0654897A (ja) * 1992-08-08 1994-03-01 Chemo Sero Therapeut Res Inst フィブリノーゲン含有製剤
JP2004538287A (ja) * 2001-07-25 2004-12-24 プロテイン デザイン ラブス インコーポレイティド ＩｇＧ抗体の安定な凍結乾燥医薬製剤
JP2012056960A (ja) * 2002-01-18 2012-03-22 Asahi Kasei Pharma Kk 可溶性トロンボモジュリン含有製剤
US20120121580A1 (en) * 2009-07-28 2012-05-17 Merck Sharp & Dohme Corp. Methods for producing high concentration lyophilized pharmaceutical formulations
JP2020500016A (ja) * 2016-11-03 2020-01-09 ブリストル−マイヤーズ スクイブ カンパニーＢｒｉｓｔｏｌ−Ｍｙｅｒｓ Ｓｑｕｉｂｂ Ｃｏｍｐａｎｙ 活性化可能な抗ｃｔｌａ−４抗体およびその使用

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
EUR. J. PHARM. BIOPHARM., vol. 85, JPN6026021945, 2013, pages 287 - 293, ISSN: 0005875222 *

Also Published As

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

Similar Documents

Publication Publication Date Title
JP7842070B2 (ja) 抗ｃｄ３８抗体の皮下製剤及びその使用
TWI761453B (zh) 抗rsv單株抗體配製物
CA2781467C (en) Formulations of antibody
ES2972527T3 (es) Formulaciones proteicas líquidas que contienen colorantes orgánicos solubles en agua
CN112105343A (zh) 抗-pd-1抗体组合物
TW201945031A (zh) 低ph藥物製劑
JP2022105056A (ja) 高濃度の抗ｖｅｇｆ抗体を含有するタンパク質溶液製剤
WO2020024932A1 (en) Method for treating cancer by combination of iap inhibitor and modulator of immune checkpoint molecule
TW201406398A (zh) 醫藥調配物
JP2024510142A5 (cg-RX-API-DMAC10.html)
JP2024510480A (ja) 融合タンパク質の新規製剤
WO2008029908A1 (fr) Préparation pharmaceutique lyophilisée stable comprenant un anticorps
JP2026077893A (ja) 医薬製剤
KR20240016260A (ko) 동결건조 단백질 제형의 가속화된 제조 방법
JP7792137B2 (ja) 高濃度の薬理学的に活性な抗体の新規製剤
US20250332251A1 (en) Use of sucrose, mannitol and glycine to reduce reconstitution time of high concentration lyophilized biologics drug products
JP2024525482A (ja) 凍結乾燥処方物を再構成する方法
JP2023526232A (ja) 活性化可能な抗ｃｔｌａ－４抗体の投薬および投与
CN115812080A (zh) 含有抗ctla-4抗体的稳定调配物
HK40126447A (en) Subcutaneous formulations of anti-cd38 antibodies and their uses
WO2026084969A1 (en) Compositions of budoprutug
HK40110786A (en) Anti-rsv monoclonal antibody formulation
KR20230106649A (ko) 제약 메토트렉세이트 조성물
TW202541845A (zh) 穩定醫藥製劑
WO2021034228A1 (ru) Водная фармацевтическая композиция антитела к pd-1 пролголимаба и ее применение

Legal Events

Date Code Title Description
RD04 Notification of resignation of power of attorney

Free format text: JAPANESE INTERMEDIATE CODE: A7424

Effective date: 20240502

RD04 Notification of resignation of power of attorney

Free format text: JAPANESE INTERMEDIATE CODE: A7424

Effective date: 20250206

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20250610

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20250610

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20260601

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20260602