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
vrs
monoclonal anti
antibody formulations
present
formulation
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 [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/08—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10—RNA viruses
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/08—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10—RNA viruses
    • C07K16/102—Coronaviridae (F)
    • C07K16/104—Severe acute respiratory syndrome coronavirus 2 [SARS‐CoV‐2]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/08—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10—RNA viruses
    • C07K16/11—Paramyxoviridae (F); Pneumoviridae (F), e.g. respiratory syncytial virus [RSV]
    • 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)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Pulmonology (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)

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 (24)

Country Link
US (4) US10774133B2 (es)
EP (1) EP3589648A4 (es)
JP (2) JP7046088B2 (es)
KR (2) KR102359181B1 (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)
MY (1) MY206022A (es)
PH (1) PH12019501979A1 (es)
SG (1) SG11201906853QA (es)
TW (3) TWI911431B (es)
UA (1) UA128450C2 (es)
WO (1) WO2018160722A1 (es)
ZA (1) ZA202006797B (es)

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TWI911431B (zh) * 2017-03-01 2026-01-11 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
CA3051864A1 (en) 2018-09-07
AU2022263564B2 (en) 2025-05-22
EP3589648A1 (en) 2020-01-08
CN116059343B (zh) 2026-06-02
CN117982637A (zh) 2024-05-07
AU2022263564A1 (en) 2022-12-15
KR102668158B1 (ko) 2024-05-23
KR20220020420A (ko) 2022-02-18
MY206022A (en) 2024-11-25
ECSP19062769A (es) 2019-09-30
CL2019002478A1 (es) 2020-01-24
CN116059343A (zh) 2023-05-05
GB201802974D0 (en) 2018-04-11
TWI761453B (zh) 2022-04-21
TW201840334A (zh) 2018-11-16
CO2019009034A2 (es) 2019-08-30
CN110418803A (zh) 2019-11-05
KR102359181B1 (ko) 2022-02-08
JP2020509031A (ja) 2020-03-26
KR20190125318A (ko) 2019-11-06
TWI911431B (zh) 2026-01-11
AR111083A1 (es) 2019-05-29
US20180251526A1 (en) 2018-09-06
IL268202B1 (en) 2024-06-01
AU2018227502B2 (en) 2022-08-11
IL312499A (en) 2024-07-01
US20200339667A1 (en) 2020-10-29
US10774133B2 (en) 2020-09-15
US11286294B2 (en) 2022-03-29
US20210317191A1 (en) 2021-10-14
US20230399383A1 (en) 2023-12-14
GB2564175B (en) 2021-12-08
TWI926892B (zh) 2026-05-21
GB2564175A (en) 2019-01-09
NZ755790A (en) 2024-04-26
PH12019501979A1 (en) 2020-06-29
AU2018227502A1 (en) 2019-08-15
SG11201906853QA (en) 2019-09-27
TW202615095A (zh) 2026-04-16
JP7446356B2 (ja) 2024-03-08
MX2019010408A (es) 2019-12-19
CN110418803B (zh) 2024-01-19
WO2018160722A1 (en) 2018-09-07
TW202228779A (zh) 2022-08-01
UA128450C2 (uk) 2024-07-17
IL268202A (en) 2019-09-26
US11667698B2 (en) 2023-06-06
JP2022095697A (ja) 2022-06-28
IL268202B2 (en) 2024-10-01
BR112019017755A2 (pt) 2020-04-07
EA201991701A1 (ru) 2020-03-04
EP3589648A4 (en) 2020-12-23
JP7046088B2 (ja) 2022-04-01
ZA202006797B (en) 2023-03-29

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