Procedure for evaluating the performance of the production process of a therapeutic protein by biotechnological means

Abstract

In this work, the performance evaluation of the production process of an immunoglobulin G (IgG) was carried out in an initial phase of technological development, with the objective of identifying a set of projects aimed at increasing productive efficiency. For this, a strategy was proposed and developed that constitutes a tool to evaluate biotechnological processes, integrating technical, economic and environmental indicators. As a result, it was shown that there was a low efficiency of the process, mainly in the fermentation stage, determined by the low use of installed capacities of only 30.45 %. Productive reserves were also identified, conditioned by the low mass of IgG obtained per volume harvested. A great dispersion in cell productivity was statistically identified for the cycles analyzed and the filtration stage of the fermented crude as the one with the lowest recovery in purification, of only 77.46 %. The economic analysis showed that expendable material and raw material expenses are the ones that most affect the unit production cost and that this presents high variability between production cycles. A set of projects are proposed that should lead to the improvement of the process and actions directed to the operation of the management systems are recommended.