BR112021006220A2 - métodos para reduzir a agregação de anticorpos biespecíficos - Google Patents

métodos para reduzir a agregação de anticorpos biespecíficos

Info

Publication number
BR112021006220A2
BR112021006220A2 BR112021006220A BR112021006220A BR112021006220A2 BR 112021006220 A2 BR112021006220 A2 BR 112021006220A2 BR 112021006220 A BR112021006220 A BR 112021006220A BR 112021006220 A BR112021006220 A BR 112021006220A BR 112021006220 A2 BR112021006220 A2 BR 112021006220A2
Authority
BR
Brazil
Prior art keywords
methods
bispecific antibody
aggregation
reducing
antibody aggregation
Prior art date
Application number
BR112021006220A
Other languages
English (en)
Inventor
Jagannathan Bharadwaj
Shan Daxian
Huh Joon
Treuheit Michael
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 BR112021006220A2 publication Critical patent/BR112021006220A2/pt

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
    • 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

Abstract

métodos para reduzir a agregação de anticorpos biespecíficos. a invenção aqui divulgada se refere a métodos para reduzir a agregação de anticorpos biespecíficos, por exemplo, reduzindo a agregação de construtos de anticorpo biespecífico acoplante de células t (bite), resultante do armazenamento em condições de congelamento, mantendo os anticorpos a certas temperaturas após o descongelamento.
BR112021006220A 2018-10-01 2019-09-27 métodos para reduzir a agregação de anticorpos biespecíficos BR112021006220A2 (pt)

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
BR112021006220A2 true BR112021006220A2 (pt) 2021-07-06

Family

ID=70055398

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112021006220A BR112021006220A2 (pt) 2018-10-01 2019-09-27 métodos para reduzir a agregação de anticorpos biespecíficos

Country Status (14)

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

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20230058432A (ko) * 2020-08-24 2023-05-03 암젠 인크 약제학적 제형
US20230398147A1 (en) * 2020-09-16 2023-12-14 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
CA3220933A1 (en) * 2021-06-30 2023-01-05 Amgen Inc. Method of reconstituting lyophilized 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
EP3418306B1 (en) * 2011-10-11 2023-12-06 F. Hoffmann-La Roche AG Improved assembly of bispecific antibodies
WO2014072277A1 (de) * 2012-11-06 2014-05-15 Bayer Pharma Aktiengesellschaft Formulierung für bispecific t-cell-engangers (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
WO2015169742A1 (en) * 2014-05-07 2015-11-12 Takeda Gmbh Liquid formulation comprising gm-csf neutralizing compound
WO2016036678A1 (en) * 2014-09-02 2016-03-10 Medimmune, Llc Formulations of bispecific antibodies
JP2019505520A (ja) * 2016-01-13 2019-02-28 ゲンマブ エー／エス 抗体およびその薬物コンジュゲートの製剤
JOP20170017B1 (ar) * 2016-01-25 2021-08-17 Amgen Res Munich Gmbh تركيب صيدلي يتضمن تركيبات جسم مضاد ثنائي الاختصاص
EP3411404B1 (en) * 2016-02-03 2022-11-09 Amgen Research (Munich) GmbH Psma and cd3 bispecific t cell engaging antibody constructs
WO2018204907A1 (en) * 2017-05-05 2018-11-08 Amgen Inc. Pharmaceutical composition comprising bispecific antibody constructs for improved storage and administration
EP3724229A1 (en) * 2017-12-11 2020-10-21 Amgen Inc. Continuous manufacturing process for bispecific antibody products

Also Published As

Publication number Publication date
CN112789028A (zh) 2021-05-11
IL281621A (en) 2021-05-31
CA3112655A1 (en) 2020-04-09
MX2021003628A (es) 2021-05-27
AU2019351715A1 (en) 2021-04-22
EP3860567A4 (en) 2022-07-06
WO2020072306A1 (en) 2020-04-09
CL2021000827A1 (es) 2021-10-15
KR20210070314A (ko) 2021-06-14
SG11202102995PA (en) 2021-04-29
JP2022512569A (ja) 2022-02-07
EP3860567A1 (en) 2021-08-11
EA202190955A1 (ru) 2021-08-17
MA53831A (fr) 2022-01-05

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