Search

In this paper we study the conditions of adsorption chromatography on Silica gel 60 for purification of Spacer disaccharide a component of Active Pharmaceutical Ingredient (API) of QuimiHib® vaccine. For that, we made a scale down on an analytical scale that represented at 1.8% of industrial process, indicating reproducibility between two procedures in terms of packing efficiency, purity and recovery. Dynamic binding capacity of the resin Silicagel 60 by the DSE was roughly 125±0.2 mg /mL, 3.4 times the base process. The elution profile obtained, showed the possibility of collecting a unique fraction at range 195±2 and 260±2 minutes, if it is maintained a proper packing of the chromatography resin determined by asymmetry factor from 0.8 to 1.2, which ensures a recovery of 58.9±4.5% and high purity analyzed by Thin Layer Chromatography. Adjusting the adsorption conditions increases the productivity of chromatographic operation up to 3.5 fold, indicating that it is feasible in economic terms. [ABSTRACT FROM AUTHOR]

The exhaustive characterization of all components of our vaccine (VA-MENGOC-BC®), is a very important information to the new strategies of production and the best quality of it. Recently some regulatory authorities have recommended to remove thiomersal from vaccines altogether. In this paper we propose a disadsorption method for later chromatographic analysis of vaccine samples with or without thiomersal to know the possible antigenic variation. Three vaccine batches, stored between 2-8 °C, were studied at 0 time using different variants of disadsorption. We have demonstrated that solubilisation of the aluminium hydroxide by HCl to release the native vaccine complex is not possible and that the most efficient disadsorption method for the chromatographic analysis of VA-MENGOC-BC® is the following: the precipitate obtained from 3 mL of vaccine is diluted in 2 mL of phosphate buffer 5mM, pH 7,2-7,3, and allowed stand exactly 2 hours at 4°C. Afterwards, the samples were centrifuged and the supernatant collected. With this method we have obtained a 20% disadsorption of the sample. The result is very useful for showing the advantages of new formulations. [ABSTRACT FROM AUTHOR]