BR112019017755A2 - formulação de anticorpo monoclonal anti-rsv - Google Patents

formulação de anticorpo monoclonal anti-rsv Download PDF

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Publication number
BR112019017755A2
BR112019017755A2 BR112019017755A BR112019017755A BR112019017755A2 BR 112019017755 A2 BR112019017755 A2 BR 112019017755A2 BR 112019017755 A BR112019017755 A BR 112019017755A BR 112019017755 A BR112019017755 A BR 112019017755A BR 112019017755 A2 BR112019017755 A2 BR 112019017755A2
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BR
Brazil
Prior art keywords
formulation
monoclonal antibody
concentration
formulation according
present
Prior art date
Application number
BR112019017755A
Other languages
English (en)
Portuguese (pt)
Inventor
Lobo Brian
Goldberg Deborah
Original Assignee
Medimmune Ltd
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 Medimmune Ltd filed Critical Medimmune Ltd
Publication of BR112019017755A2 publication Critical patent/BR112019017755A2/pt

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/42Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum viral
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/08Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/08Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
    • C07K16/1002Coronaviridae
    • C07K16/1003Severe acute respiratory syndrome coronavirus 2 [SARS‐CoV‐2 or Covid-19]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/08Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
    • C07K16/1027Paramyxoviridae, e.g. respiratory syncytial virus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • C07K2317/522CH1 domain
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Virology (AREA)
  • Organic Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pulmonology (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
BR112019017755A 2017-03-01 2018-02-28 formulação de anticorpo monoclonal anti-rsv BR112019017755A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762465379P 2017-03-01 2017-03-01
PCT/US2018/020264 WO2018160722A1 (en) 2017-03-01 2018-02-28 Anti-rsv monoclonal antibody formulation

Publications (1)

Publication Number Publication Date
BR112019017755A2 true BR112019017755A2 (pt) 2020-04-07

Family

ID=61903153

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112019017755A BR112019017755A2 (pt) 2017-03-01 2018-02-28 formulação de anticorpo monoclonal anti-rsv

Country Status (24)

Country Link
US (4) US10774133B2 (enExample)
EP (1) EP3589648A4 (enExample)
JP (2) JP7046088B2 (enExample)
KR (2) KR102668158B1 (enExample)
CN (3) CN110418803B (enExample)
AR (1) AR111083A1 (enExample)
AU (2) AU2018227502B2 (enExample)
BR (1) BR112019017755A2 (enExample)
CA (1) CA3051864A1 (enExample)
CL (1) CL2019002478A1 (enExample)
CO (1) CO2019009034A2 (enExample)
CR (1) CR20190400A (enExample)
EA (1) EA201991701A1 (enExample)
EC (1) ECSP19062769A (enExample)
GB (1) GB2564175B (enExample)
IL (2) IL268202B2 (enExample)
MX (1) MX2019010408A (enExample)
MY (1) MY206022A (enExample)
PH (1) PH12019501979A1 (enExample)
SG (1) SG11201906853QA (enExample)
TW (2) TWI761453B (enExample)
UA (1) UA128450C2 (enExample)
WO (1) WO2018160722A1 (enExample)
ZA (1) ZA202006797B (enExample)

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MX374517B (es) 2014-01-15 2025-03-06 Medimmune Ltd Anticuerpos especificos del virus respiratorio sincitial (vrs) y partes funcionales de los mismos.
EP3383435A4 (en) * 2015-11-30 2019-07-10 Medimmune, LLC OPTIMIZED RATES OF AMINO ACIDS AND SUGARS AS AMORPHOUS STABILIZING COMPOUNDS IN PHARMACEUTICAL COMPOSITIONS HAVING HIGH CONCENTRATIONS IN PROTEIN-BASED THERAPEUTICS
KR102589598B1 (ko) * 2017-03-01 2023-10-13 메디뮨 리미티드 단클론 항체의 제형
TWI761453B (zh) 2017-03-01 2022-04-21 英商梅迪繆思有限公司 抗rsv單株抗體配製物
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
US11845798B2 (en) 2017-05-02 2023-12-19 Merck Sharp & Dohme Llc Formulations of anti-LAG3 antibodies and co-formulations of anti-LAG3 antibodies and anti-PD-1 antibodies
WO2020081408A1 (en) * 2018-10-18 2020-04-23 Merck Sharp & Dohme Corp. Formulations of anti-rsv antibodies and methods of use thereof
KR20210089215A (ko) 2018-11-07 2021-07-15 머크 샤프 앤드 돔 코포레이션 항-lag3 항체 및 항-pd-1 항체의 공동-제제
KR102735988B1 (ko) 2019-02-18 2024-12-03 일라이 릴리 앤드 캄파니 치료 항체 제제
EP3956351A1 (en) * 2019-04-18 2022-02-23 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Biological and synthetic molecules inhibiting respiratory syncytial virus infection
US12024553B2 (en) * 2019-04-30 2024-07-02 Medimmune Limited Dosage regimens for and compositions including anti-RSV antibodies
ES2973425T3 (es) 2020-03-26 2024-06-20 Univ Vanderbilt Anticuerpos monoclonales humanos dirigidos contra el coronavirus 2 del síndrome respiratorio agudo grave (sars-cov-2)
CN116234576A (zh) * 2020-07-31 2023-06-06 阿拉玛布治疗学股份有限公司 抗-连接蛋白抗体制剂
CN115960214A (zh) * 2021-10-12 2023-04-14 中国科学院分子细胞科学卓越创新中心 中和呼吸道合胞病毒的全人抗体的设计及应用
TW202342510A (zh) 2022-02-18 2023-11-01 英商Rq生物科技有限公司 抗體
CN119264248A (zh) * 2022-07-22 2025-01-07 北京智仁美博生物科技有限公司 抗呼吸道合胞病毒中和性抗体及其用途
CN119998314A (zh) * 2022-12-08 2025-05-13 长春百克生物科技股份公司 特异性结合rsv的抗体

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BR112017007393A2 (pt) 2014-10-18 2017-12-19 Pfizer composições de anticorpo anti-il-7r
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TWI761453B (zh) * 2017-03-01 2022-04-21 英商梅迪繆思有限公司 抗rsv單株抗體配製物
US12024553B2 (en) * 2019-04-30 2024-07-02 Medimmune Limited Dosage regimens for and compositions including anti-RSV antibodies

Also Published As

Publication number Publication date
KR20220020420A (ko) 2022-02-18
PH12019501979A1 (en) 2020-06-29
AU2018227502A1 (en) 2019-08-15
MY206022A (en) 2024-11-25
EP3589648A4 (en) 2020-12-23
US11286294B2 (en) 2022-03-29
US20230399383A1 (en) 2023-12-14
AU2022263564B2 (en) 2025-05-22
EP3589648A1 (en) 2020-01-08
CN116059343A (zh) 2023-05-05
CL2019002478A1 (es) 2020-01-24
IL268202A (en) 2019-09-26
JP7046088B2 (ja) 2022-04-01
GB2564175B (en) 2021-12-08
CN117982637A (zh) 2024-05-07
JP7446356B2 (ja) 2024-03-08
AR111083A1 (es) 2019-05-29
CO2019009034A2 (es) 2019-08-30
ZA202006797B (en) 2023-03-29
US11667698B2 (en) 2023-06-06
ECSP19062769A (es) 2019-09-30
GB2564175A (en) 2019-01-09
JP2020509031A (ja) 2020-03-26
NZ755790A (en) 2024-04-26
US10774133B2 (en) 2020-09-15
WO2018160722A1 (en) 2018-09-07
IL268202B2 (en) 2024-10-01
AU2022263564A1 (en) 2022-12-15
EA201991701A1 (ru) 2020-03-04
KR102359181B1 (ko) 2022-02-08
TW201840334A (zh) 2018-11-16
UA128450C2 (uk) 2024-07-17
TW202228779A (zh) 2022-08-01
CA3051864A1 (en) 2018-09-07
IL312499A (en) 2024-07-01
JP2022095697A (ja) 2022-06-28
IL268202B1 (en) 2024-06-01
CN110418803A (zh) 2019-11-05
TWI761453B (zh) 2022-04-21
US20180251526A1 (en) 2018-09-06
GB201802974D0 (en) 2018-04-11
KR102668158B1 (ko) 2024-05-23
SG11201906853QA (en) 2019-09-27
CR20190400A (es) 2019-12-03
KR20190125318A (ko) 2019-11-06
CN110418803B (zh) 2024-01-19
US20200339667A1 (en) 2020-10-29
US20210317191A1 (en) 2021-10-14
MX2019010408A (es) 2019-12-19
AU2018227502B2 (en) 2022-08-11

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