Abstract

VALDERRAMA, Susset et al. Establishment and validation of an ELISA-type immunoenzymatic assay, used for quality control of human recombinant alpha-2b Interferon. Vaccimonitor [online]. 2009, vol.18, n.1, pp.8-14. ISSN 1025-028X.

An ELISA for quantification of human recombinant alpha-2b Interferon in the Active Pharmaceutical Ingredient (API) was established and validated, and the validity criteria for the assay were defined, based on Good Laboratory Practices compliance. The following parameters were evaluated: linearity, specificity, accuracy, range, precision and robustness. The assay was specific, with accuracy from 84.3 to 102.4%, a quadratic adjustment and a working range from 1 to 10 ng/mL, repetibility and intermediate precision with coefficients of variation lower than 10% and 20% respectively, and robustness confirmed in relation to the edge effect and the stability of solutions.

Keywords : ELISA; ELISA; human recombinant alpha-2b Interferon; validation.

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