AR117650A1 - Procesamiento posterior de constructos de anticuerpos biespecíficos - Google Patents

Procesamiento posterior de constructos de anticuerpos biespecíficos

Info

Publication number
AR117650A1
AR117650A1 ARP190102910A ARP190102910A AR117650A1 AR 117650 A1 AR117650 A1 AR 117650A1 AR P190102910 A ARP190102910 A AR P190102910A AR P190102910 A ARP190102910 A AR P190102910A AR 117650 A1 AR117650 A1 AR 117650A1
Authority
AR
Argentina
Prior art keywords
construct
domain
refolding
buffer
concentration
Prior art date
Application number
ARP190102910A
Other languages
English (en)
Inventor
Neil Soice
Pavel Bondarenko
Pik Chan
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 AR117650A1 publication Critical patent/AR117650A1/es

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C07K1/18—Ion-exchange chromatography
    • 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
    • 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
    • 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
    • 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
    • C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • 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
    • 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
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation

Abstract

La presente proporciona un método de fabricación mejorado para la producción de constructos de anticuerpos biespecíficos, que comprenden al menos dos dominios de unión. El procedimiento comprende al menos el método que comprende una etapa de replegamiento del constructo, en el que uno o más de los dominios comprenden un enlace disulfuro, y en el que el constructo se pone en contacto con un tampón de replegamiento para replegar el constructo a su forma nativa, comprendiendo el tampón (i) un agente redox y/u oxidante que tiene una concentración de al menos 0.1 mM y (ii) un agente caótropo que tiene una concentración > 1 M, y en el que el pH del tampón de replegamiento corresponde a +/- 4.5 del valor de pI del primer dominio o +/- 4.0 del valor de pI de todo el constructo. Reivindicación 1: Un método de purificación de un constructo de anticuerpo biespecífico, comprendiendo el constructo: un primer dominio que tiene un pI de 5.0 a 9.5 que se une a una diana tumoral; un segundo dominio que se une a un epítopo extracelular de la cadena CD3e humana y de Macaca; y opcionalmente un tercer dominio que comprende dos monómeros de polipéptido, comprendiendo cada uno una bisagra, un dominio CH2 y un dominio CH3, en el que dichos dos monómeros de polipéptido se fusionan entre sí por medio de un enlazador peptídico, en el que el constructo comprende al menos un puente disulfuro abierto, en el que uno o más de los dominios comprenden un enlace disulfuro, el método caracterizado porque comprende una etapa de replegamiento del constructo, en el que el constructo se pone en contacto con un tampón de replegamiento para replegar el constructo a su forma nativa, comprendiendo el tampón (i) un agente redox y/u oxidante que tiene una concentración de al menos 0.1 mM donde el agente redox se selecciona del grupo que consiste de glutatión reducido / glutatión oxidado, cisteína / cistina, cisteína / cisteamina, cisteína / cistamina, ditiotreitol (DTT), b-mercaptoetanol y glutatión, y donde el agente oxidante se selecciona del grupo que consiste de cobre(II), oxígeno disuelto y ácido (L)-dehidroascórbico (DHA), y (ii) un agente caotrópico que tiene una concentración en el rango de 1 M a 2,5 M, donde el agente caotrópico se selecciona del grupo que consiste de urea, dimetil urea, metilurea, etilurea, solventes orgánicos y guanidinio, y en el que el pH del tampón de replegamiento corresponde a +/- 4.5 del valor de pI del primer dominio o +/- 4.0 del valor de pI de todo el constructo.
ARP190102910A 2018-10-11 2019-10-11 Procesamiento posterior de constructos de anticuerpos biespecíficos AR117650A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201862744595P 2018-10-11 2018-10-11

Publications (1)

Publication Number Publication Date
AR117650A1 true AR117650A1 (es) 2021-08-18

Family

ID=68425302

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP190102910A AR117650A1 (es) 2018-10-11 2019-10-11 Procesamiento posterior de constructos de anticuerpos biespecíficos

Country Status (13)

Country Link
US (1) US20210395298A1 (es)
EP (1) EP3863670A1 (es)
JP (1) JP2022512636A (es)
CN (1) CN112789058A (es)
AR (1) AR117650A1 (es)
AU (1) AU2019356564A1 (es)
CA (1) CA3114802A1 (es)
CL (1) CL2021000874A1 (es)
IL (1) IL281788A (es)
MX (1) MX2021003976A (es)
SG (1) SG11202103275YA (es)
TW (1) TW202027788A (es)
WO (1) WO2020077212A1 (es)

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JP2022512636A (ja) 2022-02-07
EP3863670A1 (en) 2021-08-18
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CL2021000874A1 (es) 2021-10-15
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