CR20190400A - Formulaciones de anticuerpo monoclonal anti-vrs - Google Patents

Formulaciones de anticuerpo monoclonal anti-vrs

Info

Publication number
CR20190400A
CR20190400A CR20190400A CR20190400A CR20190400A CR 20190400 A CR20190400 A CR 20190400A CR 20190400 A CR20190400 A CR 20190400A CR 20190400 A CR20190400 A CR 20190400A CR 20190400 A CR20190400 A CR 20190400A
Authority
CR
Costa Rica
Prior art keywords
monoclonal antibody
antibody formulation
rsv monoclonal
formulation
present
Prior art date
Application number
CR20190400A
Other languages
English (en)
Inventor
Deborah Goldberg
Brian Lobo
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 CR20190400A publication Critical patent/CR20190400A/es

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
    • 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
    • A61K39/42—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum viral
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/08—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/08—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
    • C07K16/1002—Coronaviridae
    • C07K16/1003—Severe acute respiratory syndrome coronavirus 2 [SARS‐CoV‐2 or Covid-19]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/08—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
    • C07K16/1027—Paramyxoviridae, e.g. respiratory syncytial virus
    • 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
    • C07K2317/20—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
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/522—CH1 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
    • 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
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • 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)
  • 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)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Pulmonology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Oil, Petroleum & Natural Gas (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)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

La presente invención proporciona una formulación que comprende: (i) un anticuerpo monoclonal anti-VRS; y (ii) un excipiente iónico; en donde el anticuerpo monoclonal está presente a una concentración de aproximadamente 50 mg/ml o más y el excipiente iónico está presente a una concentración de entre 50 y 150 mM y la formulación tiene un pH de aproximadamente 5.5 a aproximadamente 7.5.The present invention provides a formulation comprising: (i) an anti-RSV monoclonal antibody; and (ii) an ionic excipient; wherein the monoclonal antibody is present at a concentration of about 50mg/ml or greater and the ionic excipient is present at a concentration of between 50 and 150 mM and the formulation has a pH of about 5.5 to about 7.5.
CR20190400A 2017-03-01 2018-02-28 Formulaciones de anticuerpo monoclonal anti-vrs CR20190400A (es)

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
CR20190400A true CR20190400A (es) 2019-12-03

Family

ID=61903153

Family Applications (1)

Application Number Title Priority Date Filing Date
CR20190400A CR20190400A (es) 2017-03-01 2018-02-28 Formulaciones de anticuerpo monoclonal anti-vrs

Country Status (23)

Country Link
US (4) US10774133B2 (es)
EP (1) EP3589648A4 (es)
JP (2) JP7046088B2 (es)
KR (2) KR102668158B1 (es)
CN (3) CN110418803B (es)
AR (1) AR111083A1 (es)
AU (2) AU2018227502B2 (es)
BR (1) BR112019017755A2 (es)
CA (1) CA3051864A1 (es)
CL (1) CL2019002478A1 (es)
CO (1) CO2019009034A2 (es)
CR (1) CR20190400A (es)
EA (1) EA201991701A1 (es)
EC (1) ECSP19062769A (es)
GB (1) GB2564175B (es)
IL (2) IL312499A (es)
MX (1) MX2019010408A (es)
PH (1) PH12019501979A1 (es)
SG (1) SG11201906853QA (es)
TW (2) TWI761453B (es)
UA (1) UA128450C2 (es)
WO (1) WO2018160722A1 (es)
ZA (1) ZA202006797B (es)

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HUE048855T2 (hu) 2014-01-15 2020-08-28 Medimmune Llc RSV-re specifikus ellenanyagok és azok funkcionális részei
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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
EP3589318A1 (en) * 2017-03-01 2020-01-08 MedImmune Limited Formulations of monoclonal antibodies
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
SG11201909955XA (en) 2017-05-02 2019-11-28 Merck Sharp & Dohme Formulations of anti-lag3 antibodies and co-formulations of anti-lag3 antibodies and anti-pd-1 antibodies
EP3867271A4 (en) 2018-10-18 2022-08-03 Merck Sharp & Dohme Corp. ANTI-RSV ANTIBODY FORMULATIONS AND METHODS OF USE THEREOF
MX2021009851A (es) 2019-02-18 2021-09-10 Lilly Co Eli Formulacion de anticuerpos terapeuticos.
CN113993884A (zh) * 2019-04-18 2022-01-28 弗劳恩霍夫应用研究促进协会 抑制呼吸道合胞病毒感染的生物及合成分子
US12024553B2 (en) 2019-04-30 2024-07-02 Medimmune Limited Dosage regimens for and compositions including anti-RSV antibodies
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
WO2024016842A1 (zh) * 2022-07-22 2024-01-25 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
WO2024120517A1 (zh) * 2022-12-08 2024-06-13 南京诺唯赞生物科技股份有限公司 特异性结合rsv的抗体

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JO3555B1 (ar) 2015-10-29 2020-07-05 Merck Sharp & Dohme جسم مضاد يبطل فعالية فيروس الالتهاب الرئوي البشري
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
EP3589318A1 (en) * 2017-03-01 2020-01-08 MedImmune Limited Formulations of monoclonal antibodies

Also Published As

Publication number Publication date
ECSP19062769A (es) 2019-09-30
EP3589648A1 (en) 2020-01-08
EA201991701A1 (ru) 2020-03-04
KR102668158B1 (ko) 2024-05-23
TWI761453B (zh) 2022-04-21
IL268202B2 (en) 2024-10-01
CL2019002478A1 (es) 2020-01-24
US11286294B2 (en) 2022-03-29
JP7046088B2 (ja) 2022-04-01
AU2018227502A1 (en) 2019-08-15
AU2018227502B2 (en) 2022-08-11
MX2019010408A (es) 2019-12-19
GB201802974D0 (en) 2018-04-11
KR102359181B1 (ko) 2022-02-08
IL268202A (en) 2019-09-26
CN110418803B (zh) 2024-01-19
IL312499A (en) 2024-07-01
BR112019017755A2 (pt) 2020-04-07
CA3051864A1 (en) 2018-09-07
UA128450C2 (uk) 2024-07-17
WO2018160722A1 (en) 2018-09-07
ZA202006797B (en) 2023-03-29
KR20220020420A (ko) 2022-02-18
IL268202B1 (en) 2024-06-01
SG11201906853QA (en) 2019-09-27
JP2022095697A (ja) 2022-06-28
CN116059343A (zh) 2023-05-05
JP2020509031A (ja) 2020-03-26
PH12019501979A1 (en) 2020-06-29
US11667698B2 (en) 2023-06-06
GB2564175B (en) 2021-12-08
CN117982637A (zh) 2024-05-07
CO2019009034A2 (es) 2019-08-30
US10774133B2 (en) 2020-09-15
GB2564175A (en) 2019-01-09
EP3589648A4 (en) 2020-12-23
TW201840334A (zh) 2018-11-16
US20180251526A1 (en) 2018-09-06
US20210317191A1 (en) 2021-10-14
KR20190125318A (ko) 2019-11-06
AR111083A1 (es) 2019-05-29
AU2022263564A1 (en) 2022-12-15
NZ755790A (en) 2024-04-26
US20200339667A1 (en) 2020-10-29
TW202228779A (zh) 2022-08-01
CN110418803A (zh) 2019-11-05
JP7446356B2 (ja) 2024-03-08
US20230399383A1 (en) 2023-12-14

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