JP7813222B2 - 高濃度抗ｃ５製剤 - Google Patents

高濃度抗ｃ５製剤

Info

Publication number
JP7813222B2
JP7813222B2 JP2022509593A JP2022509593A JP7813222B2 JP 7813222 B2 JP7813222 B2 JP 7813222B2 JP 2022509593 A JP2022509593 A JP 2022509593A JP 2022509593 A JP2022509593 A JP 2022509593A JP 7813222 B2 JP7813222 B2 JP 7813222B2
Authority
JP
Japan
Prior art keywords
formulation
pharmaceutical
pharmaceutical formulation
intravenous
disease
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.)
Active
Application number
JP2022509593A
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English (en)
Japanese (ja)
Other versions
JP2022544589A5 (https=
JP2022544589A (ja
Inventor
マリー・クレッペ
マヤンク・パテル
シャオリン・タン
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.)
Regeneron Pharmaceuticals Inc
Original Assignee
Regeneron Pharmaceuticals Inc
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 Regeneron Pharmaceuticals Inc filed Critical Regeneron Pharmaceuticals Inc
Publication of JP2022544589A publication Critical patent/JP2022544589A/ja
Publication of JP2022544589A5 publication Critical patent/JP2022544589A5/ja
Priority to JP2025151837A priority Critical patent/JP2026003133A/ja
Application granted granted Critical
Publication of JP7813222B2 publication Critical patent/JP7813222B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K9/08—Solutions
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • 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

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)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Mycology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Genetics & Genomics (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Endocrinology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2022509593A 2019-08-16 2020-08-14 高濃度抗ｃ５製剤 Active JP7813222B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2025151837A JP2026003133A (ja) 2019-08-16 2025-09-12 高濃度抗ｃ５製剤

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962888086P 2019-08-16 2019-08-16
US62/888,086 2019-08-16
PCT/US2020/046314 WO2021034639A1 (en) 2019-08-16 2020-08-14 High concentration anti-c5 formulations

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2025151837A Division JP2026003133A (ja) 2019-08-16 2025-09-12 高濃度抗ｃ５製剤

Publications (3)

Publication Number Publication Date
JP2022544589A JP2022544589A (ja) 2022-10-19
JP2022544589A5 JP2022544589A5 (https=) 2023-08-15
JP7813222B2 true JP7813222B2 (ja) 2026-02-12

Family

ID=72560889

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2022509593A Active JP7813222B2 (ja) 2019-08-16 2020-08-14 高濃度抗ｃ５製剤
JP2025151837A Pending JP2026003133A (ja) 2019-08-16 2025-09-12 高濃度抗ｃ５製剤

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2025151837A Pending JP2026003133A (ja) 2019-08-16 2025-09-12 高濃度抗ｃ５製剤

Country Status (15)

Country Link
US (1) US20210046182A1 (https=)
EP (1) EP4013784A1 (https=)
JP (2) JP7813222B2 (https=)
KR (1) KR20220047826A (https=)
CN (1) CN116782876A (https=)
AU (1) AU2020334880A1 (https=)
BR (1) BR112022002831A2 (https=)
CA (1) CA3145621A1 (https=)
CL (1) CL2022000340A1 (https=)
CO (1) CO2022001097A2 (https=)
IL (1) IL290034A (https=)
JO (1) JOP20220030A1 (https=)
MX (1) MX2022001896A (https=)
PH (1) PH12022550167A1 (https=)
WO (1) WO2021034639A1 (https=)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL288931B2 (en) 2013-03-14 2025-05-01 Alnylam Pharmaceuticals Inc Compositions comprising a complementary portion of C5 IRNA and methods of using them
CN107635527B (zh) 2015-03-10 2021-04-23 里珍纳龙药品有限公司 无菌刺穿系统和方法
CN116769024A (zh) 2016-06-14 2023-09-19 瑞泽恩制药公司 抗c5抗体及其用途
IL308643B2 (en) 2017-05-05 2025-02-01 Regeneron Pharma Auto-injector
CA3274059A1 (en) 2017-12-13 2026-03-02 Regeneron Pharmaceuticals, Inc. Anti-c5 antibody combinations and uses thereof
US20240415980A1 (en) 2021-10-28 2024-12-19 Regeneron Pharmaceuticals, Inc. Crispr/cas-related methods and compositions for knocking out c5
USD1007676S1 (en) 2021-11-16 2023-12-12 Regeneron Pharmaceuticals, Inc. Wearable autoinjector
KR20250044336A (ko) * 2022-07-27 2025-03-31 세파론 엘엘씨 궤양성 결장염 및 크론병의 치료를 위한 항-tl1a 항체
IL318297A (en) * 2022-07-27 2025-03-01 Cephalon Llc Anti-TL1A antibody formulations
JP2025536552A (ja) * 2022-10-28 2025-11-07 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 抗Ｃ５抗体／Ｃ５ ｉＲＮＡ合剤および併用療法
CN121548440A (zh) 2023-06-16 2026-02-17 里珍纳龙药品有限公司 医疗装置包装及相关方法
CN116712390B (zh) * 2023-08-04 2023-11-14 上海览屹医药科技有限公司 一种高浓度高稳定性的抗体制剂及其制备方法
WO2025075970A1 (en) 2023-10-02 2025-04-10 Regeneron Pharmaceuticals, Inc. Drug delivery device safety system
CN118460651B (zh) * 2024-07-10 2025-03-18 凯莱英医药集团（天津）股份有限公司 制备Cemdisiran的方法
CN119454939A (zh) * 2024-11-28 2025-02-18 北海康成(苏州)生物制药有限公司 一种欧莫扑拜单抗原液及其制备方法

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010515742A (ja) 2007-01-09 2010-05-13 ワイス エルエルシー 抗ｉｌ−１３抗体製剤およびその使用
JP2012519706A (ja) 2009-03-06 2012-08-30 ジェネンテック， インコーポレイテッド 抗体製剤
JP2017105754A (ja) 2015-10-01 2017-06-15 ファイザー・インク 低粘度抗体組成物
WO2019023564A1 (en) 2017-07-27 2019-01-31 Alexion Pharmaceutical, Inc. ANTI-C5 ANTIBODY FORMULATIONS WITH HIGH CONCENTRATION
WO2019084438A1 (en) 2017-10-26 2019-05-02 Alexion Pharmaceuticals, Inc. ASSAY AND ADMINISTRATION OF ANTI-C5 ANTIBODIES FOR THE TREATMENT OF NOCTURNAL PAROXYSTIC HEMOGLOBINURIA (PNH) AND ATYPICAL HEMOLYTIC AND UREMIC SYNDROME (AHUS)

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US4816567A (en) 1983-04-08 1989-03-28 Genentech, Inc. Recombinant immunoglobin preparations
US5981501A (en) 1995-06-07 1999-11-09 Inex Pharmaceuticals Corp. Methods for encapsulating plasmids in lipid bilayers
AU733310C (en) 1997-05-14 2001-11-29 University Of British Columbia, The High efficiency encapsulation of charged therapeutic agents in lipid vesicles
US8101348B2 (en) 2002-07-10 2012-01-24 Max-Planck-Gesellschaft Zur Foerderung Der Wissenschaften E.V. RNA-interference by single-stranded RNA molecules
ITMI20021527A1 (it) 2002-07-11 2004-01-12 Consiglio Nazionale Ricerche Anticorpi anti componente c5 del complemento e loro uso
CA2638811A1 (en) * 2006-02-03 2007-08-16 Medimmune, Llc Protein formulations
CA2721333C (en) 2008-04-15 2020-12-01 Protiva Biotherapeutics, Inc. Novel lipid formulations for nucleic acid delivery
PY09026846A (es) 2008-08-05 2015-09-01 Novartis Ag Composiciones y métodos para anticuerpos que se dirigen a la proteína de complemento c5
KR101766408B1 (ko) 2009-06-10 2017-08-10 알닐람 파마슈티칼스 인코포레이티드 향상된 지질 조성물
IL288931B2 (en) 2013-03-14 2025-05-01 Alnylam Pharmaceuticals Inc Compositions comprising a complementary portion of C5 IRNA and methods of using them
US10238700B2 (en) * 2014-01-02 2019-03-26 Genelux Corporation Oncolytic virus adjunct therapy with agents that increase virus infectivity
CA2940319A1 (en) 2014-03-20 2015-09-24 Inflarx Gmbh Inhibitors of c5a for the treatment of viral pneumonia
EP3464351A1 (en) 2016-06-07 2019-04-10 Novartis AG Anti-c5 antibody for treating patients with complement c5 polymorphism
CN116769024A (zh) * 2016-06-14 2023-09-19 瑞泽恩制药公司 抗c5抗体及其用途
EP3522918A1 (en) * 2016-10-06 2019-08-14 Amgen Inc. Reduced viscosity protein pharmaceutical formulations
CA3274059A1 (en) * 2017-12-13 2026-03-02 Regeneron Pharmaceuticals, Inc. Anti-c5 antibody combinations and uses thereof

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010515742A (ja) 2007-01-09 2010-05-13 ワイス エルエルシー 抗ｉｌ−１３抗体製剤およびその使用
JP2012519706A (ja) 2009-03-06 2012-08-30 ジェネンテック， インコーポレイテッド 抗体製剤
JP2017105754A (ja) 2015-10-01 2017-06-15 ファイザー・インク 低粘度抗体組成物
WO2019023564A1 (en) 2017-07-27 2019-01-31 Alexion Pharmaceutical, Inc. ANTI-C5 ANTIBODY FORMULATIONS WITH HIGH CONCENTRATION
WO2019084438A1 (en) 2017-10-26 2019-05-02 Alexion Pharmaceuticals, Inc. ASSAY AND ADMINISTRATION OF ANTI-C5 ANTIBODIES FOR THE TREATMENT OF NOCTURNAL PAROXYSTIC HEMOGLOBINURIA (PNH) AND ATYPICAL HEMOLYTIC AND UREMIC SYNDROME (AHUS)

Also Published As

Publication number Publication date
CA3145621A1 (en) 2021-02-25
JP2022544589A (ja) 2022-10-19
US20210046182A1 (en) 2021-02-18
MX2022001896A (es) 2022-06-02
AU2020334880A1 (en) 2022-03-24
BR112022002831A2 (pt) 2022-06-28
PH12022550167A1 (en) 2023-05-08
CO2022001097A2 (es) 2022-03-08
KR20220047826A (ko) 2022-04-19
CN116782876A (zh) 2023-09-19
JP2026003133A (ja) 2026-01-09
JOP20220030A1 (ar) 2023-01-30
IL290034A (en) 2022-03-01
CL2022000340A1 (es) 2022-10-07
WO2021034639A1 (en) 2021-02-25
WO2021034639A4 (en) 2021-04-15
EP4013784A1 (en) 2022-06-22

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