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Revista Cubana de Farmacia
versión On-line ISSN 1561-2988
Resumen
VEGA, Maribel et al. Establecimiento de un material de referencia de trabajo para interleucina-2 recombinante. Rev Cubana Farm [online]. 2005, vol.39, n.2, pp. 1-1. ISSN 1561-2988.
Establishment of a working reference material for recombinant interleukin-2 Interleukin-2 is a human glycoprotein with 133 aminoacids that is crucial for attaining an effective immunological reaction. In the Center of Genetic Engineering and Biotechnology this protein has been obtained as a recombinant product from Eschericia coli bacteria. For the quality control of every batch produced, it was necessary to establish a working reference material. In this paper we describe the steps taken to obtain a candidate batch and the preparation of the working material as such. It was proved that the working pattern obtained.is homogenous for its use in the analytical techniques of quality control of interleukin-2. A loss of activity lower than an annual 5 % was predicted by an accelerated stability study. Adequate values were attained for the purity of the reference material, evaluated by electrophoresis, and for the biological activity that was established with traceability to the international reference material for this product.
Palabras clave : Reference material; interleukin-2; working reference material; patterns; standard.