Incremento en la capacidad de procesamiento para la producción de N-Glicolil GM3

The N-Glicolil GM 3 is a monosialilganglioside used as antigen and adjuvant in vaccines preparations for therapeutic use against breast, lung and melanoma cancer. The obtaining process of this ganglioside from equine erythrocytes comprises two stages: extraction and purification, in which we work to increment processing volumes. The assessment of increment in the processing capacity, its influence on the performance and the evaluation of purification process behavior by Preparative High-Performance Liquid Chromatography (Prep HPLC) constituted the objectives of this paper. The results obtained from the approved procedure and the proposal of change were compared. The process was controlled by evaluating the organoleptic characteristics and weight of lyophilized extract, as well as the detection and content of N-Glicolyl GM 3 by Qualitative Thin Layer Chromatography and colorimetric analysis of sialic acid; STATGRAPHICS software was used to assess the process variability. The increment in processing volume regarding the established procedure remained the extraction stage performance and incremented slightly the purification performance, by reducing the processing time with the use of Prep HPLC. The increment of processing capacity maintained the overall performance of the process in 0,006 g of N-Glicolyl GM 3 /g of erythrocytes and the product obtained by means of the proposed method fulfilled the quality specifications established for the same; allowing an increment in productivity by 30%, less energy consumption and less exhaustion of human resources, being feasible to implement the change.