MA51629A - Procédés de production, purification et formulation de conjugués anticorps-médicaments - Google Patents

Procédés de production, purification et formulation de conjugués anticorps-médicaments

Info

Publication number
MA51629A
MA51629A MA051629A MA51629A MA51629A MA 51629 A MA51629 A MA 51629A MA 051629 A MA051629 A MA 051629A MA 51629 A MA51629 A MA 51629A MA 51629 A MA51629 A MA 51629A
Authority
MA
Morocco
Prior art keywords
antibody
formulation
purification
processes
production
Prior art date
Application number
MA051629A
Other languages
English (en)
Inventor
Robert W Herbst
Benjamin M Hutchins
Daniel F Milano
Michael R Reardon
Richard A Silva
Original Assignee
Immunogen 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 Immunogen Inc filed Critical Immunogen Inc
Publication of MA51629A publication Critical patent/MA51629A/fr

Links

Classifications

    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6835—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6849—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a receptor, a cell surface antigen or a cell surface determinant
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5365—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines ortho- or peri-condensed with heterocyclic ring systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/5383—1,4-Oxazines, e.g. morpholine ortho- or peri-condensed with heterocyclic ring systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • A61K31/5513—1,4-Benzodiazepines, e.g. diazepam or clozapine
    • A61K31/5517—1,4-Benzodiazepines, e.g. diazepam or clozapine condensed with five-membered rings having nitrogen as a ring hetero atom, e.g. imidazobenzodiazepines, triazolam
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/68033—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a maytansine
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/68035—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a pyrrolobenzodiazepine
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6889—Conjugates wherein the antibody being the modifying agent and wherein the linker, binder or spacer confers particular properties to the conjugates, e.g. peptidic enzyme-labile linkers or acid-labile linkers, providing for an acid-labile immuno conjugate wherein the drug may be released from its antibody conjugated part in an acidic, e.g. tumoural or environment
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/34—Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6854—Immunoglobulins
    • 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
    • C07K16/2866—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Analytical Chemistry (AREA)
  • Cell Biology (AREA)
  • Biomedical Technology (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Water Supply & Treatment (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Food Science & Technology (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
MA051629A 2018-01-12 2019-01-11 Procédés de production, purification et formulation de conjugués anticorps-médicaments MA51629A (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201862617021P 2018-01-12 2018-01-12
US201862673535P 2018-05-18 2018-05-18

Publications (1)

Publication Number Publication Date
MA51629A true MA51629A (fr) 2020-11-18

Family

ID=67219931

Family Applications (1)

Application Number Title Priority Date Filing Date
MA051629A MA51629A (fr) 2018-01-12 2019-01-11 Procédés de production, purification et formulation de conjugués anticorps-médicaments

Country Status (12)

Country Link
US (2) US11274121B2 (fr)
EP (1) EP3737421A4 (fr)
JP (2) JP7474195B2 (fr)
KR (1) KR20200108843A (fr)
CN (1) CN111587125A (fr)
AU (1) AU2019206587A1 (fr)
CA (1) CA3087993A1 (fr)
IL (1) IL275798A (fr)
MA (1) MA51629A (fr)
SG (1) SG11202005541QA (fr)
TW (1) TW201934187A (fr)
WO (1) WO2019140141A1 (fr)

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CN113150145B (zh) 2013-08-30 2025-02-14 伊缪诺金公司 用于检测叶酸受体1的抗体和测定
US10413615B2 (en) * 2014-11-19 2019-09-17 Immunogen, Inc. Process for preparing cell-binding agent-cytotoxic agent conjugates
AU2016285552B2 (en) 2015-06-29 2022-10-13 Immunogen, Inc. Anti-CD123 antibodies and conjugates and derivatives thereof
KR20200046050A (ko) * 2017-08-14 2020-05-06 후지레비오 다이어그노스틱스, 인코포레이티드 항체 접합 방법
CN119264211A (zh) 2018-08-27 2025-01-07 瑞泽恩制药公司 拉曼光谱在下游纯化中的应用
KR20220022112A (ko) 2019-03-21 2022-02-24 이뮤노젠 아이엔씨 세포-결합 제제-약물 콘쥬게이트를 준비하는 방법
MA55818A (fr) 2019-04-29 2022-03-16 Immunogen Inc Anticorps et immunoconjugués de fr-alpha biparatopique
WO2021097281A1 (fr) 2019-11-15 2021-05-20 Lonza Ltd Procédé et système de production d'un inoculum
EP3939691B1 (fr) 2020-07-13 2023-11-22 Sartorius Stedim Biotech GmbH Dispositif d'assemblage de production de bio-conjugués
WO2022140271A1 (fr) * 2020-12-21 2022-06-30 The United States Of America, As Represented By The Secretary, Department Of Health And Human Services Systèmes de perfusion adaptative et procédés de test de libération de médicament
KR102942648B1 (ko) 2021-02-09 2026-03-20 진콴텀 헬스케어 (쑤저우) 씨오., 엘티디. 결합 장치 및 결합 화합물을 생성하는 방법
EP4347661A4 (fr) * 2021-06-04 2025-06-18 ImmunoGen, Inc. Traitement du cancer chez des patients porteurs de fr-alpha soluble
WO2023038067A1 (fr) * 2021-09-08 2023-03-16 味の素株式会社 Intermédiaire d'anticorps modifié de manière sélective sur un site, et procédé de production d'un dérivé d'anticorps qui comporte de manière sélective d'un site un groupe fonctionnel ou une substance fonctionnelle
WO2023183269A1 (fr) * 2022-03-21 2023-09-28 Repligen Corporation Système de tff automatisé basé sur la spectroscopie uv à longueur de trajet variable
WO2024246657A1 (fr) * 2023-05-29 2024-12-05 Intas Pharmaceuticals Ltd. Procédé de conjugaison et de purification d'un conjugué anticorps-médicament
KR20250157730A (ko) 2024-04-29 2025-11-05 주식회사 넥사 항체약물접합체 제조 장치 및 방법
EP4675260A1 (fr) 2024-07-02 2026-01-07 Merck Patent GmbH Spectroscopie raman pour la surveillance en temps réel de la clairance de solvant dans des processus en aval

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CA3000520C (fr) * 2005-08-24 2023-04-04 Immunogen, Inc. Procede de preparation de conjugues maytansinoides-anticorps
SG189817A1 (en) * 2008-04-30 2013-05-31 Immunogen Inc Potent conjugates and hydrophilic linkers
SG10201810743WA (en) 2009-06-03 2018-12-28 Immunogen Inc Conjugation methods
TWI622402B (zh) 2010-02-24 2018-05-01 免疫遺傳股份有限公司 葉酸受體１抗體類和免疫共軛物類及彼等之用途
JP5826863B2 (ja) * 2011-02-15 2015-12-02 イミュノジェン・インコーポレーテッド 細胞傷害性ベンゾジアゼピン誘導体
MY171008A (en) 2011-03-29 2019-09-23 Immunogen Inc Preparation of maytansinoid antibody conjugates by a one-step process
EP2524929A1 (fr) 2011-05-17 2012-11-21 Sanofi Utilisation d'anticorps immunoconjugués anti-CD19 maytansinoïdes pour le traitement de symptômes de malignités CD19+lymphocytes B
WO2014055842A1 (fr) * 2012-10-04 2014-04-10 Immunogen, Inc. Procédé de préparation de conjugués maytansinoïdes anticorps stables
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KR102508023B1 (ko) * 2014-09-03 2023-03-10 이뮤노젠 아이엔씨 세포-결합제 및 세포독성 약물을 포함하는 콘주게이트
AU2016285552B2 (en) 2015-06-29 2022-10-13 Immunogen, Inc. Anti-CD123 antibodies and conjugates and derivatives thereof
KR102344339B1 (ko) * 2016-04-04 2021-12-28 베링거 인겔하임 에르체파우 게엠베하 운트 코 카게 제제 정제의 실시간 모니터링
CA3023486C (fr) * 2016-06-09 2022-03-29 Emd Millipore Corporation Elements filtrants a trajet radial, systemes et procedes d'utilisation de ces derniers
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US20180230218A1 (en) 2017-01-04 2018-08-16 Immunogen, Inc. Met antibodies and immunoconjugates and uses thereof
EP3624839A4 (fr) 2017-05-17 2021-06-16 Immunogen, Inc. Schémas posologiques d'immunoconjugués anti-cd33
EP3431168A1 (fr) * 2017-07-19 2019-01-23 Bayer Aktiengesellschaft Élimination de médicament non lié après accouplement conjugué anticorps-médicament

Also Published As

Publication number Publication date
RU2020121946A (ru) 2022-03-10
KR20200108843A (ko) 2020-09-21
JP2021510694A (ja) 2021-04-30
SG11202005541QA (en) 2020-07-29
TW201934187A (zh) 2019-09-01
US11274121B2 (en) 2022-03-15
US20190270769A1 (en) 2019-09-05
WO2019140141A1 (fr) 2019-07-18
CN111587125A (zh) 2020-08-25
JP2024019597A (ja) 2024-02-09
US20220267371A1 (en) 2022-08-25
CA3087993A1 (fr) 2019-07-18
EP3737421A4 (fr) 2022-03-16
AU2019206587A1 (en) 2020-08-06
EP3737421A1 (fr) 2020-11-18
IL275798A (en) 2020-08-31
JP7474195B2 (ja) 2024-04-24

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