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The engineered protein inhibitor of human neutrophil elastase, Epi-hNE4, is being developed for the treatment of cystic fibrosis. Like many recombinant proteins, Epi-hNE4 may induce antibodies in pre-clinical species and in humans. The aim of this report was to validate an ELISA to assess its immunogenicity in monkeys. We have designed and optimized a classical ELISA in which Epi-hNE4 was coated directly...
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