EA202190955A1 - Способы снижения агрегации биспецифических антител - Google Patents

Способы снижения агрегации биспецифических антител

Info

Publication number
EA202190955A1
EA202190955A1 EA202190955A EA202190955A EA202190955A1 EA 202190955 A1 EA202190955 A1 EA 202190955A1 EA 202190955 A EA202190955 A EA 202190955A EA 202190955 A EA202190955 A EA 202190955A EA 202190955 A1 EA202190955 A1 EA 202190955A1
Authority
EA
Eurasian Patent Office
Prior art keywords
methods
bispecific antibodies
reducing aggregation
aggregation
reducing
Prior art date
Application number
EA202190955A
Other languages
English (en)
Inventor
Бхарадвадж Джаганнатан
Джун Хух
Майкл Тройхайт
Дасянь Шань
Original Assignee
Эмджен Инк.
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 Эмджен Инк. filed Critical Эмджен Инк.
Publication of EA202190955A1 publication Critical patent/EA202190955A1/ru

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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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2809—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against the T-cell receptor (TcR)-CD3 complex
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2878—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/10—Immunoglobulins specific features characterized by their source of isolation or production
    • C07K2317/14—Specific host cells or culture conditions, e.g. components, pH or temperature
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/622—Single chain antibody (scFv)
    • 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)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Public Health (AREA)
  • Molecular Biology (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)

Abstract

Изобретение, раскрытое в данном документе, относится к способам снижения агрегации биспецифических антител, например снижения агрегации конструкций на основе биспецифического антитела-рекрутера Т-клеток (BiTE), в результате хранения в условиях заморозки с помощью выдерживания антител при определенных температурах после размораживания.
EA202190955A 2018-10-01 2019-09-27 Способы снижения агрегации биспецифических антител EA202190955A1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201862739542P 2018-10-01 2018-10-01
PCT/US2019/053462 WO2020072306A1 (en) 2018-10-01 2019-09-27 Methods for reducing aggregation of bispecific antibodies

Publications (1)

Publication Number Publication Date
EA202190955A1 true EA202190955A1 (ru) 2021-08-17

Family

ID=70055398

Family Applications (1)

Application Number Title Priority Date Filing Date
EA202190955A EA202190955A1 (ru) 2018-10-01 2019-09-27 Способы снижения агрегации биспецифических антител

Country Status (14)

Country Link
EP (1) EP3860567A4 (ru)
JP (1) JP2022512569A (ru)
KR (1) KR20210070314A (ru)
CN (1) CN112789028A (ru)
AU (1) AU2019351715A1 (ru)
BR (1) BR112021006220A2 (ru)
CA (1) CA3112655A1 (ru)
CL (1) CL2021000827A1 (ru)
EA (1) EA202190955A1 (ru)
IL (1) IL281621A (ru)
MA (1) MA53831A (ru)
MX (1) MX2021003628A (ru)
SG (1) SG11202102995PA (ru)
WO (1) WO2020072306A1 (ru)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4200333A1 (en) * 2020-08-24 2023-06-28 Amgen Inc. Pharmaceutical formulation comprising a bite, bispecific antibody, and methionine
WO2022060878A1 (en) * 2020-09-16 2022-03-24 Amgen Inc. Methods for treating prostate cancer
EP4214233A1 (en) * 2020-09-16 2023-07-26 Amgen Inc. Methods for administering therapeutic doses of bispecific t-cell engaging molecules for the treatment of cancer
CN117377695A (zh) * 2021-06-30 2024-01-09 安进公司 冻干制剂的重构方法
WO2024059675A2 (en) * 2022-09-14 2024-03-21 Amgen Inc. Bispecific molecule stabilizing composition

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX359384B (es) * 2011-10-11 2018-09-25 Genentech Inc Conjunto mejorado de anticuerpos bisespecificos.
TR201809507T4 (tr) * 2012-11-06 2018-07-23 Bayer Pharma AG Bispesifik T-hücresi bağlayıcıları (BİTE'ler) için formülasyon.
TWI679019B (zh) * 2013-04-29 2019-12-11 法商賽諾菲公司 抗ｉｌ－４／抗ｉｌ－１３之雙特異性抗體調配物
ES2974895T3 (es) * 2014-05-07 2024-07-02 Takeda Pharmaceuticals Co Formulación líquida que comprende un compuesto neutralizante de GM-CSF
WO2016036678A1 (en) * 2014-09-02 2016-03-10 Medimmune, Llc Formulations of bispecific antibodies
MX2018008300A (es) * 2016-01-13 2018-09-21 Genmab As Formulacion para anticuerpo y conjugado de farmaco del mismo.
TWI797073B (zh) * 2016-01-25 2023-04-01 德商安美基研究（慕尼黑）公司 包含雙特異性抗體建構物之醫藥組合物
LT3411404T (lt) * 2016-02-03 2022-12-27 Amgen Research (Munich) Gmbh Psma ir cd3 bispecifiniai, t ląsteles aktyvuojantys antikūno konstruktai
US11918650B2 (en) * 2017-05-05 2024-03-05 Amgen Inc. Pharmaceutical composition comprising bispecific antibody constructs for improved storage and administration
CA3082507A1 (en) * 2017-12-11 2019-06-20 Amgen Inc. Continuous manufacturing process for bispecific antibody products

Also Published As

Publication number Publication date
CL2021000827A1 (es) 2021-10-15
EP3860567A1 (en) 2021-08-11
WO2020072306A1 (en) 2020-04-09
KR20210070314A (ko) 2021-06-14
JP2022512569A (ja) 2022-02-07
MX2021003628A (es) 2021-05-27
AU2019351715A1 (en) 2021-04-22
EP3860567A4 (en) 2022-07-06
IL281621A (en) 2021-05-31
CN112789028A (zh) 2021-05-11
SG11202102995PA (en) 2021-04-29
MA53831A (fr) 2022-01-05
CA3112655A1 (en) 2020-04-09
BR112021006220A2 (pt) 2021-07-06

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