The increasing competition between pharmaceutical companies over the last few decades has led to more efficient ways of producing drug substances, and also the rationalization of production methods. Thus, costs are cut in every part of the production process. The purification or separation cost is one of these.
The purification step, and large-scale HPLC separation in the production of a pharmaceutical substance, can represent a significant proportion of the total production cost. It is therefore vital to optimize the running conditions (e.g. flow rate, column bed length, loading amount, particle size, etc) to minimize this cost.
The packing media used in the separation process are the single most important element that can influence the total separation cost. Therefore, choosing the right media is critical to the separation process, as well as the complete production stage.
When HPLC separations are performed on an industrial scale, the cost of solvent is normally 50–8 0%, and the cost of the packing material typically 5–10%. Labor, equipment and lost crude account for the remaining 10–40% of the total cost.
By using the right packing material, with increased loadability, the productivity can be increased, and the total separation cost can be reduced significantly. We call this the leverage effect in HPLC. (See section Leveraging productivity with Kromasil.)
Using the best packing media in the large scale HPLC separation process is no longer enough. Although this offers a lower separation cost and better quality of separation, further demands for production process optimization need to be satisfied to provide better production yield and even lower costs.
For this reason, the supplier of the silica needs to have advanced knowledge and experience in performing thorough optimization, and achieving a cost-effective separation.
The process of analyzing and optimizing the total purification process can be fairly complex, especially when performing multi-dimensional optimization of your chromatography. Kromasil has developed a tool, KromaGuide, that allows you to greatly simplify this process. In some cases, the test and comparison of varying conditions can be done in minutes. There is also an experienced team to guide you through this process.