ES2965486T3 - Formulaciones de anticuerpos anti-C5 de alta concentración - Google Patents

Formulaciones de anticuerpos anti-C5 de alta concentración Download PDF

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Publication number
ES2965486T3
ES2965486T3 ES18755604T ES18755604T ES2965486T3 ES 2965486 T3 ES2965486 T3 ES 2965486T3 ES 18755604 T ES18755604 T ES 18755604T ES 18755604 T ES18755604 T ES 18755604T ES 2965486 T3 ES2965486 T3 ES 2965486T3
Authority
ES
Spain
Prior art keywords
antibody
aqueous solution
alxn1210
months
solution
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
ES18755604T
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English (en)
Spanish (es)
Inventor
Stephan Ortiz
Jillian Gentile
Leena Philominathan
Eric Routhier
Bruce Mason
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.)
Alexion Pharmaceuticals Inc
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
Application granted granted Critical
Publication of ES2965486T3 publication Critical patent/ES2965486T3/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61K39/39591—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)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Inorganic Chemistry (AREA)
  • Urology & Nephrology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (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)
ES18755604T 2017-07-27 2018-07-27 Formulaciones de anticuerpos anti-C5 de alta concentración Active ES2965486T3 (es)

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
ES2965486T3 true ES2965486T3 (es) 2024-04-15

Family

ID=63209670

Family Applications (1)

Application Number Title Priority Date Filing Date
ES18755604T Active ES2965486T3 (es) 2017-07-27 2018-07-27 Formulaciones de anticuerpos anti-C5 de alta concentración

Country Status (19)

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

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2019517473A (ja) 2016-05-27 2019-06-24 アレクシオン ファーマシューティカルズ インコーポレイテッドＡｌｅｘｉｏｎ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ， Ｉｎｃ． 難治性全身型重症筋無力症の処置のための方法
SI3658184T1 (sl) 2017-07-27 2024-01-31 Alexion Pharmaceuticals, Inc., Formulacije z visoko koncentracijo protiteles proti-C5
CA3080187A1 (en) 2017-10-26 2019-05-02 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh) and atypical hemolytic uremic syndrome (ahus)
JP7577542B2 (ja) 2018-06-04 2024-11-05 アレクシオン ファーマシューティカルズ， インコーポレイテッド 小児患者における非典型溶血性尿毒症症候群（ａＨＵＳ）の治療のための抗Ｃ５抗体の用量および投与
WO2020006266A1 (en) 2018-06-28 2020-01-02 Alexion Pharmaceuticals, Inc. Methods of producing anti-c5 antibodies
CN112996561A (zh) * 2018-10-30 2021-06-18 亚力兄制药公司 用于治疗阵发性睡眠性血红蛋白尿症(pnh)的抗c5抗体的皮下剂量和施用
CA3127797A1 (en) * 2019-01-25 2020-07-30 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment of atypical hemolytic uremic syndrome (ahus)
MX2021009789A (es) * 2019-02-14 2021-11-17 Alexion Pharma Inc Dosificacion y administracion de anticuerpos anti-c5 para el tratamiento de miastenia gravis generalizada.
JP7813222B2 (ja) * 2019-08-16 2026-02-12 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 高濃度抗ｃ５製剤
AU2020337093B2 (en) * 2019-08-30 2025-02-27 Kashiv Biosciences, Llc Novel formulation of highly concentrated pharmacologically active antibody
WO2021067526A1 (en) * 2019-10-02 2021-04-08 Alexion Pharmaceuticals, Inc. Complement inhibitors for treating drug-induced complement-mediated response
EP4054634A1 (en) * 2019-11-08 2022-09-14 Alexion Pharmaceuticals, Inc. High concentration anti-c5 antibody formulations
JP2023520249A (ja) * 2020-05-15 2023-05-16 エフ． ホフマン－ラ ロシュ アーゲー 非経口タンパク質溶液中の可視粒子形成の防止方法
CN116261569A (zh) * 2020-09-21 2023-06-13 阿雷克森制药公司 用于治疗包括狼疮性肾炎（LN）和/或IgA肾病（IgAN）的C5介导的肾小球肾炎（GN）的抗C5抗体的剂量和施用
KR20230134533A (ko) * 2021-01-22 2023-09-21 알렉시온 파마슈티칼스, 인코포레이티드 항-c5 항체를 이용한 보체 매개 혈전성 미세혈관병증의치료 방법
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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