Abstract

PEREZ, Eliana et al. Validation of an ELISA for the quantification of protein impurities from host strain on the active principle of the Cuban recombinant vaccine against hepatitis B. Vaccimonitor [online]. 2014, vol.23, n.1, pp.11-16. ISSN 1025-028X.

A double sandwich immunoassay was validated to quantify antibody protein impurities from host strain that can be present in the active pharmaceutical ingredient of Cuban vaccine against hepatitis B. All biological reagents used in the ELISA were prepared and characterized. The proteins from the host strain were obtained under the same conditions as the production process of the recombinant protein until a purification or primary semipurification step. The antisera addressed against those proteins were generated in rabbits by an immunization process in cascade. For validation the parameters analyzed were: linearity, limit of detection and quantification, accuracy, range and precision. The established assay was specific, and the calculated accuracy was from 89% to 109% for all studied buffers. A parabolic fit and a working range from 0.63 to 1.25 ng/mL were demonstrated. The repeatability and intermediate precision showed variation coefficients below 10% and 20% respectively.

Keywords : ELISA; hepatitis B; vaccine; validation.

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