Resumen

SANCHEZ-LABANINO, Sadiely; SEURET-HERNANDEZ, Niurka  y  MAYO- ABAD, Orestes. Improvements in the recombinant streptokinase active pharmaceutical ingredient conforming stage. RTQ [online]. 2015, vol.35, n.2, pp. 167-180. ISSN 2224-6185.

The Streptokinase way recombinant engineering was obtained at the Center of Genetic Engineering and Biotechnology (CIGB) in 1989 and after the technology transference to the National Center for Bioproducts (BioCen) in 2002, it has been possible to stably produce this medicament. Thanks to the effective and economic character of this protein it is widely used in some cases, under medical indications, to dissolve blood clots in myocardial infarction, deep venous thrombosis, ischemic brain infarction, lung embolisms, etc. In this work the Methodology of Process Analysis is used in order to find technical and organizational measures among which stand out; the formation of a work group, the substitution of part of the main equipment. That way, it was possible to strengthen the stage of API Conformation, with the application of a closed system, the introduction of flexible plastic bags of ethyl vinyl acetate and Sartorius capsules in the final filtration, allowing the process more operative, fast and aseptic. The impact achieved in the reduction of losses up to a 3 % was evaluated, demonstrating the economic feasibility of the measures taken.

Palabras clave : Non conformities; pyrogens; Active Pharmaceutical Ingredient (API); closed system.

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