DK1648940T3 - Reduktion af udvaskning af protein A under protein A-affinitetskromatografi - Google Patents

Reduktion af udvaskning af protein A under protein A-affinitetskromatografi Download PDF

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Publication number
DK1648940T3
DK1648940T3 DK04777121.7T DK04777121T DK1648940T3 DK 1648940 T3 DK1648940 T3 DK 1648940T3 DK 04777121 T DK04777121 T DK 04777121T DK 1648940 T3 DK1648940 T3 DK 1648940T3
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Prior art keywords
protein
antibody
antibodies
humanized
leaching
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DK04777121.7T
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English (en)
Inventor
Robert L Fahrner
Amy Laverdiere
Paul J Mcdonald
Rhona M O'leary
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Genentech Inc
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    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/38—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving specific interaction not covered by one or more of groups B01D15/265 - B01D15/36
    • B01D15/3804—Affinity chromatography
    • B01D15/3809—Affinity chromatography of the antigen-antibody type, e.g. protein A, G, L chromatography
    • 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
    • C07K1/22—Affinity chromatography or related techniques based upon selective absorption processes
    • 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
    • C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • 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
    • C07K16/2839—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 integrin superfamily
    • C07K16/2845—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 integrin superfamily against integrin beta2-subunit-containing molecules, e.g. CD11, CD18
    • 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
    • C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Molecular Biology (AREA)
  • Medicinal Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Analytical Chemistry (AREA)
  • Oncology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Peptides Or Proteins (AREA)
  • Enzymes And Modification Thereof (AREA)

Claims (10)

1. Fremgangsmåde til oprensning af et protein, som omfatter en Chi2/CH3-region, ved hjælp af protein A-affinitetskromatografi, hvor en indledende protein A-kromatografi, der udføres ved en rumtemperatur på mere end 20 °C, resulterer i mere end 20 ng udvasket protein A per mg protein, som er til stede i en oprenset sammensætning, hvilken fremgangsmåde omfatter: (a) at udsætte en prøve af proteinet og en eller flere urenheder for protein A-affinitetskromatografi, hvor prøvens temperatur ved en reduceret temperatur er i området fra 3 °C til 15 °C, (b) at genindvinde den oprensede sammensætning, der er opnået, og (c) at måle det udvaskede protein A i den oprensede sammensætning, hvor udvaskningen af protein A er reduceret i den oprensede sammensætning, der er opnået ved den reducerede temperatur, og den oprensede sammensætning indeholder 0 ng protein A til 15 ng protein A per mg protein.
2. Fremgangsmåde ifølge krav 1, yderligere omfattende at udsætte sammensætningen, som har været underkastet protein A-affinitetskromatografi, for en proteaseinhibitor.
3. Fremgangsmåde ifølge krav 2, hvorved proteaseinhibitoren er EDTA eller 4-(2-aminoethyl)-benzensulfonyl-fluorid, hydrochlorid (AEBSF).
4. Fremgangsmåde ifølge krav 1, hvorved proteinet er et antistof.
5. Fremgangsmåde ifølge krav 4, hvorved antistoffet binder et antigen, udvalgt fra gruppen bestående af FIER2, vaskulær endothelial vækstfaktor (VEGF), IgE, CD20, CD40, CD11a, vævsfaktor (TF), prostatastamcelleanti-gen (PSCA), interleukin-8 (IL-8), epidermal vækstfaktorreceptor (EGFR), HER3, HER4, α4β7 og α5β3.
6. Fremgangsmåde ifølge krav 4, hvorved antistoffet udvælges fra gruppen bestående af trastuzumab, humaniseret 2C4, humaniseret CD11a-antistof og humaniseret VEGF-antistof.
7. Fremgangsmåde ifølge krav 4, hvorved antistoffet binder HER2-antigen.
8. Fremgangsmåde ifølge krav 7, hvorved antistoffet er trastuzumab eller humaniseret 2C4.
9. Fremgangsmåde ifølge krav 1, hvorved proteinet er et immunoadhesin.
10. Fremgangsmåde ifølge krav 9, hvorved inmunoadhesinet er et TNF-receptor- immunoadhesin.
DK04777121.7T 2003-07-28 2004-06-24 Reduktion af udvaskning af protein A under protein A-affinitetskromatografi DK1648940T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US49050003P 2003-07-28 2003-07-28
PCT/US2004/020480 WO2005016968A2 (en) 2003-07-28 2004-06-24 Reducing protein a leaching during protein a affinity chromatography

Publications (1)

Publication Number Publication Date
DK1648940T3 true DK1648940T3 (da) 2016-08-15

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Application Number Title Priority Date Filing Date
DK16164203.8T DK3095793T3 (da) 2003-07-28 2004-06-24 Reducering af udvaskning af protein A under en protein A-affinitetskromatografi
DK04777121.7T DK1648940T3 (da) 2003-07-28 2004-06-24 Reduktion af udvaskning af protein A under protein A-affinitetskromatografi

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DK16164203.8T DK3095793T3 (da) 2003-07-28 2004-06-24 Reducering af udvaskning af protein A under en protein A-affinitetskromatografi

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US (2) US7485704B2 (da)
EP (3) EP3722309A1 (da)
JP (1) JP4599355B2 (da)
AU (1) AU2004265253B2 (da)
CA (1) CA2531595C (da)
DK (2) DK3095793T3 (da)
ES (1) ES2786568T3 (da)
HR (1) HRP20200589T1 (da)
HU (2) HUE050171T2 (da)
LT (1) LT3095793T (da)
PL (2) PL1648940T3 (da)
PT (1) PT3095793T (da)
SI (2) SI1648940T1 (da)
WO (1) WO2005016968A2 (da)

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WO2005016968A3 (en) 2005-04-21
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SI3095793T1 (sl) 2020-07-31
SI1648940T1 (sl) 2016-08-31
CA2531595C (en) 2015-12-08
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US7807799B2 (en) 2010-10-05
US20090099344A1 (en) 2009-04-16
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