MX2021003628A - Metodos para reducir la agregacion de anticuerpos biespecificos. - Google Patents

Metodos para reducir la agregacion de anticuerpos biespecificos.

Info

Publication number
MX2021003628A
MX2021003628A MX2021003628A MX2021003628A MX2021003628A MX 2021003628 A MX2021003628 A MX 2021003628A MX 2021003628 A MX2021003628 A MX 2021003628A MX 2021003628 A MX2021003628 A MX 2021003628A MX 2021003628 A MX2021003628 A MX 2021003628A
Authority
MX
Mexico
Prior art keywords
methods
reducing aggregation
bispecific antibodies
bispecific
antibodies
Prior art date
Application number
MX2021003628A
Other languages
English (en)
Inventor
Joon Huh
Michael Treuheit
Bharadwaj Jagannathan
Daxian Shan
Original Assignee
Amgen Inc
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 Amgen Inc filed Critical Amgen Inc
Publication of MX2021003628A publication Critical patent/MX2021003628A/es

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Classifications

    • 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
    • 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
    • A61K9/19—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)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Public Health (AREA)
  • Biochemistry (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

La invención descrita en el presente documento se refiere a métodos para reducir la agregación de anticuerpos biespecíficos, por ejemplo, reducir la agregación de construcciones de anticuerpos acopladores de linfocitos T biespecíficos (BiTE), debida al almacenamiento en condiciones de congelación mediante la retención de los anticuerpos a determinadas temperaturas después de la descongelación.
MX2021003628A 2018-10-01 2019-09-27 Metodos para reducir la agregacion de anticuerpos biespecificos. MX2021003628A (es)

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
MX2021003628A true MX2021003628A (es) 2021-05-27

Family

ID=70055398

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2021003628A MX2021003628A (es) 2018-10-01 2019-09-27 Metodos para reducir la agregacion de anticuerpos biespecificos.

Country Status (14)

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

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022046651A1 (en) * 2020-08-24 2022-03-03 Amgen Inc. Pharmaceutical formulation comprising a bite, bispecific antibody, and methionine
AU2021345124A1 (en) * 2020-09-16 2023-03-30 Amgen Inc. Methods for administering therapeutic doses of bispecific T-cell engaging molecules for the treatment of cancer
WO2022060878A1 (en) * 2020-09-16 2022-03-24 Amgen Inc. Methods for treating prostate cancer
IL308847A (en) * 2021-06-30 2024-01-01 Amgen Inc The method of recovering a freeze-dried formulation
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
KR102106002B1 (ko) * 2011-10-11 2020-05-07 제넨테크, 인크. 이중특이적 항체의 개선된 어셈블리
PT2916866T (pt) * 2012-11-06 2018-07-10 Amgen Inc Formulação para ativadores de células t bispecíficas (bites)
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
JP6769879B2 (ja) * 2014-05-07 2020-10-14 タケダ・ゲー・エム・ベー・ハーＴａｋｅｄａ ＧｍｂＨ Ｇｍ−ｃｓｆ中和化合物を含む液体製剤
WO2016036678A1 (en) * 2014-09-02 2016-03-10 Medimmune, Llc Formulations of bispecific antibodies
WO2017121867A1 (en) * 2016-01-13 2017-07-20 Genmab A/S Formulation for antibody and drug conjugate thereof
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
SI3411404T1 (sl) * 2016-02-03 2023-01-31 Amgen Research (Munich) Gmbh Konstrukti bispecifičnih protiteles PSMA in CD3, ki aktivirajo T celico
AR111773A1 (es) * 2017-05-05 2019-08-21 Amgen Inc Composición farmacéutica que comprende constructos de anticuerpos biespecíficos para almacenamiento y administración
EA202091422A1 (ru) * 2017-12-11 2020-08-28 Эмджен Инк. Способ непрерывного производства продуктов на основе биспецифических антител

Also Published As

Publication number Publication date
IL281621A (en) 2021-05-31
BR112021006220A2 (pt) 2021-07-06
EP3860567A1 (en) 2021-08-11
CA3112655A1 (en) 2020-04-09
KR20210070314A (ko) 2021-06-14
EP3860567A4 (en) 2022-07-06
CN112789028A (zh) 2021-05-11
AU2019351715A1 (en) 2021-04-22
MA53831A (fr) 2022-01-05
JP2022512569A (ja) 2022-02-07
SG11202102995PA (en) 2021-04-29
CL2021000827A1 (es) 2021-10-15
WO2020072306A1 (en) 2020-04-09
EA202190955A1 (ru) 2021-08-17

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