TWI911431B - 抗rsv單株抗體配製物 - Google Patents

抗rsv單株抗體配製物

Info

Publication number
TWI911431B
TWI911431B TW111113045A TW111113045A TWI911431B TW I911431 B TWI911431 B TW I911431B TW 111113045 A TW111113045 A TW 111113045A TW 111113045 A TW111113045 A TW 111113045A TW I911431 B TWI911431 B TW I911431B
Authority
TW
Taiwan
Prior art keywords
formulation
monoclonal antibody
concentration
chain variable
variable region
Prior art date
Application number
TW111113045A
Other languages
English (en)
Chinese (zh)
Other versions
TW202228779A (zh
Inventor
布萊恩 羅玻
黛博拉 高登伯格
Original Assignee
英商梅迪繆思有限公司
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 英商梅迪繆思有限公司 filed Critical 英商梅迪繆思有限公司
Publication of TW202228779A publication Critical patent/TW202228779A/zh
Application granted granted Critical
Publication of TWI911431B publication Critical patent/TWI911431B/zh

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)
TW111113045A 2017-03-01 2018-02-13 抗rsv單株抗體配製物 TWI911431B (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762465379P 2017-03-01 2017-03-01
US62/465,379 2017-03-01

Publications (2)

Publication Number Publication Date
TW202228779A TW202228779A (zh) 2022-08-01
TWI911431B true TWI911431B (zh) 2026-01-11

Family

ID=61903153

Family Applications (3)

Application Number Title Priority Date Filing Date
TW111113045A TWI911431B (zh) 2017-03-01 2018-02-13 抗rsv單株抗體配製物
TW114151960A TWI926892B (zh) 2017-03-01 2018-02-13 抗ｒｓｖ單株抗體配製物
TW107105368A TWI761453B (zh) 2017-03-01 2018-02-13 抗rsv單株抗體配製物

Family Applications After (2)

Application Number Title Priority Date Filing Date
TW114151960A TWI926892B (zh) 2017-03-01 2018-02-13 抗ｒｓｖ單株抗體配製物
TW107105368A TWI761453B (zh) 2017-03-01 2018-02-13 抗rsv單株抗體配製物

Country Status (24)

Country Link
US (4) US10774133B2 (enExample)
EP (1) EP3589648A4 (enExample)
JP (2) JP7046088B2 (enExample)
KR (2) KR102359181B1 (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) IL312499A (enExample)
MX (1) MX2019010408A (enExample)
MY (1) MY206022A (enExample)
PH (1) PH12019501979A1 (enExample)
SG (1) SG11201906853QA (enExample)
TW (3) TWI911431B (enExample)
UA (1) UA128450C2 (enExample)
WO (1) WO2018160722A1 (enExample)
ZA (1) ZA202006797B (enExample)

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UA117466C2 (uk) 2012-12-13 2018-08-10 Мерк Шарп Енд Доме Корп. СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19
RS60387B1 (sr) 2014-01-15 2020-07-31 Medimmune Llc Rsv-specifična antitela i njihovi funkcionalni delovi
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
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
JP2020509025A (ja) * 2017-03-01 2020-03-26 メドイミューン・リミテッドＭｅｄＩｍｍｕｎｅ Ｌｉｍｉｔｅｄ モノクローナル抗体製剤
JOP20190260A1 (ar) 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
CN110913906A (zh) 2017-05-02 2020-03-24 默沙东公司 抗lag3抗体的制剂和抗lag3抗体与抗pd-1抗体的共制剂
MX2021004356A (es) 2018-10-18 2021-05-31 Merck Sharp & Dohme Llc Formulaciones de anticuerpos anti-rsv y metodos de uso de las mismas.
MA54089A (fr) 2018-10-31 2022-02-09 Merck Sharp & Dohme Anticorps anti-pd-1 humain et procédés d'utilisation associés
JP7503056B6 (ja) 2018-11-07 2024-07-16 メルク・シャープ・アンド・ドーム・エルエルシー 抗ｌａｇ３抗体および抗ｐｄ－１抗体の共－製剤
PE20212185A1 (es) 2019-02-18 2021-11-11 Lilly Co Eli Formulacion de anticuerpos terapeuticos
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
WO2021195418A1 (en) 2020-03-26 2021-09-30 Vanderbilt University Human monoclonal antibodies to severe acute respiratory syndrome coronavirus 2 (sars-cov-2)
IL300245A (en) * 2020-07-31 2023-03-01 Alamab Therapeutics Inc Anti-connexin antibody formulations
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
CN116987183B (zh) * 2022-07-22 2024-10-15 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
EP4588936A4 (en) * 2022-12-08 2026-08-12 Changchun Bcht Biotechnology Co ANTIBODIES THAT BIND SPECIFICALLY TO VRS
CN121846262A (zh) * 2026-01-05 2026-04-14 上海生物制品研究所有限责任公司 抗呼吸道合胞病毒单克隆抗体制剂

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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
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
CR20190400A (es) 2019-12-03
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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