PL3658184T3 - Formulacje przeciwciała anty-C5 o wysokim stężeniu - Google Patents

Formulacje przeciwciała anty-C5 o wysokim stężeniu

Info

Publication number
PL3658184T3
PL3658184T3 PL18755604.8T PL18755604T PL3658184T3 PL 3658184 T3 PL3658184 T3 PL 3658184T3 PL 18755604 T PL18755604 T PL 18755604T PL 3658184 T3 PL3658184 T3 PL 3658184T3
Authority
PL
Poland
Prior art keywords
high concentration
antibody formulations
concentration anti
antibody
formulations
Prior art date
Application number
PL18755604.8T
Other languages
English (en)
Inventor
Stephan ORTIZ
Jillian GENTILE
Leena PHILOMINATHAN
Eric Routhier
Bruce Mason
Original Assignee
Alexion 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 Alexion Pharmaceuticals, Inc. filed Critical Alexion Pharmaceuticals, Inc.
Publication of PL3658184T3 publication Critical patent/PL3658184T3/pl

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
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • 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
    • A61K47/16—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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
    • 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
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/526—CH3 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • 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)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Dermatology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Urology & Nephrology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
PL18755604.8T 2017-07-27 2018-07-27 Formulacje przeciwciała anty-C5 o wysokim stężeniu PL3658184T3 (pl)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762537741P 2017-07-27 2017-07-27
PCT/US2018/044071 WO2019023564A1 (en) 2017-07-27 2018-07-27 ANTI-C5 ANTIBODY FORMULATIONS WITH HIGH CONCENTRATION

Publications (1)

Publication Number Publication Date
PL3658184T3 true PL3658184T3 (pl) 2024-02-26

Family

ID=63209670

Family Applications (1)

Application Number Title Priority Date Filing Date
PL18755604.8T PL3658184T3 (pl) 2017-07-27 2018-07-27 Formulacje przeciwciała anty-C5 o wysokim stężeniu

Country Status (19)

Country Link
US (4) US11365241B2 (pl)
EP (2) EP3658184B1 (pl)
JP (4) JP7079844B2 (pl)
KR (2) KR102576012B1 (pl)
CN (2) CN116271012A (pl)
AU (3) AU2018306612C1 (pl)
BR (1) BR112020001703B1 (pl)
CA (1) CA3069756C (pl)
CO (1) CO2020001960A2 (pl)
DK (1) DK3658184T5 (pl)
ES (1) ES2965486T3 (pl)
FI (1) FI3658184T3 (pl)
HU (1) HUE064436T2 (pl)
LT (1) LT3658184T (pl)
MX (2) MX392444B (pl)
PL (1) PL3658184T3 (pl)
PT (1) PT3658184T (pl)
SI (1) SI3658184T1 (pl)
WO (1) WO2019023564A1 (pl)

Families Citing this family (20)

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CA3024618A1 (en) 2016-05-27 2017-11-30 Alexion Pharmaceuticals, Inc. Methods for treatment of refractory generalized myasthenia gravis
DK3658184T5 (da) 2017-07-27 2024-08-26 Alexion Pharma Inc Højkoncentrerede anti-c5-antistofformuleringer
CN118512588A (zh) 2017-10-26 2024-08-20 亚力兄制药公司 用于治疗阵发性夜间性血红蛋白尿(pnh)和非典型溶血性尿毒症综合征(ahus)的抗c5抗体的剂量和施用
EP3802603A1 (en) 2018-06-04 2021-04-14 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment of atypical hemolytic uremic syndrome (ahus) in pediatric patients
US12312394B2 (en) 2018-06-28 2025-05-27 Alexion Pharmaceuticals, Inc. Methods of producing anti-C5 antibodies
EP3873602B1 (en) * 2018-10-30 2023-12-06 Alexion Pharmaceuticals, Inc. Subcutaneous dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh)
CN117838856A (zh) * 2019-01-25 2024-04-09 亚力兄制药公司 用于治疗非典型溶血性尿毒综合征(ahus)的抗c5抗体的剂量和施用
EP3924380A1 (en) * 2019-02-14 2021-12-22 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment of generalized myasthenia gravis
WO2021034639A1 (en) * 2019-08-16 2021-02-25 Regeneron Pharmaceuticals, Inc. High concentration anti-c5 formulations
EP4021497B1 (en) * 2019-08-30 2026-02-25 Kashiv Biosciences, LLC Novel formulation of highly concentrated pharmacologically active antibody
US20220356234A1 (en) * 2019-10-02 2022-11-10 Alexion Pharmaceuticals, Inc. Complement inhibitors for treating drug-induced complement-mediated response
WO2021091937A1 (en) * 2019-11-08 2021-05-14 Alexion Pharmaceuticals, Inc. High concentration anti-c5 antibody formulations
CN115605184A (zh) * 2020-05-15 2023-01-13 豪夫迈·罗氏有限公司（Ch） 防止胃肠外蛋白质溶液中的可见颗粒形成
EP4213940A1 (en) * 2020-09-21 2023-07-26 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treating c5-mediated glomerular nephritis (gn), including lupus nephritis (ln) and/or iga nephropathy (igan)
EP4281472A1 (en) * 2021-01-22 2023-11-29 Alexion Pharmaceuticals, Inc. Methods of treating complement mediated thrombotic microangiopathy using an anti-c5 antibody
TW202404632A (zh) * 2022-04-04 2024-02-01 瑞士商赫孚孟拉羅股份公司 用於藉由使用抗ｃ５抗體克羅伐單抗治療或預防格林－巴利症候群之劑量及投予方案
TW202423479A (zh) * 2022-09-28 2024-06-16 美商阿雷希昂製藥公司 用於預防或最小化患有慢性腎病的患者中的心臟手術相關急性腎損傷（csa-aki）和/或隨後的主要不良腎事件（make）的抗c5抗體之劑量及投與
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
CN118604345A (zh) * 2024-05-31 2024-09-06 上海览屹医药科技有限公司 酶联免疫方法测定单克隆抗体浓度
CN121186347B (zh) * 2025-11-24 2026-02-24 国家心血管病中心 一种利用动脉血对目标物质进行免疫检测的方法和试剂盒

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