AU2019252941B2 - Stable anti-CD79B immunoconjugate formulations - Google Patents

Stable anti-CD79B immunoconjugate formulations

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Publication number
AU2019252941B2
AU2019252941B2 AU2019252941A AU2019252941A AU2019252941B2 AU 2019252941 B2 AU2019252941 B2 AU 2019252941B2 AU 2019252941 A AU2019252941 A AU 2019252941A AU 2019252941 A AU2019252941 A AU 2019252941A AU 2019252941 B2 AU2019252941 B2 AU 2019252941B2
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Australia
Prior art keywords
liquid composition
cd79b
composition
antibody
seq
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AU2019252941A
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AU2019252941A1 (en
Inventor
Jun Liu
Ankit R. Patel
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Genentech Inc
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Genentech Inc
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], 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
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    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
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