Atsushi Koiwa

Scale-up of liquid chromatography for industrial production of parenteral antibiotic E1077

Purification is a key process for the commercialization of new chemical compounds. This is especially the case of pharmaceutical compounds, which require high quality. Optimization of the purification process is a primary concern. An industrial-scale process was developed for synthesizing a new cephalosporin, 3-aminopropenyl-7-fluoromethoxyiminothiadiazolylcephem (E-1077). Column chromatography was applied to purify this product. Optimum conditions for production were determined on the basis of analytical-scale studies. The process was then scaled up to the pilot production of samples. In order to achieve successful scale-up of industrial chromatography, it is necessary to consider the chemical nature of the crude compound and optimization of each step in the total production process.