Abstract
Etanercept is a soluble tumor necrosis factor (TNF) receptor originally approved for treatment of moderate-to-severe rheumatoid arthritis, juvenile rheumatoid arthritis, and psoriatic arthritis. We have developed a non-innovator version of the recombinant protein etanercept, with the investigational name AVG01 (trade name AVENT™), using a novel expression vector-based technology. Here we show, by extensive analytical characterization, that AVG01 is highly similar to the reference product Enbrel® and demonstrates similar efficacy in pre-clinical studies.
Copyright © 2011 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.
MeSH terms
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Animals
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Antirheumatic Agents / pharmacology
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Arthritis / drug therapy*
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Blotting, Western
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CHO Cells
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Cell Line, Tumor
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Chromatography, High Pressure Liquid
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Cricetinae
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Cricetulus
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Disease Models, Animal
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Drug Evaluation, Preclinical
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Etanercept
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Female
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Humans
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Immunoglobulin G / analysis
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Immunoglobulin G / genetics
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Immunoglobulin G / pharmacology*
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Male
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Mice
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Mice, Inbred C57BL
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Mice, Inbred CBA
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Receptors, Tumor Necrosis Factor / analysis
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Receptors, Tumor Necrosis Factor / genetics
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Recombinant Proteins / analysis
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Recombinant Proteins / pharmacology*
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Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization
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Treatment Outcome
Substances
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Antirheumatic Agents
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Immunoglobulin G
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Receptors, Tumor Necrosis Factor
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Recombinant Proteins
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Etanercept