Most of the commodity active pharmaceutical ingredients (API) are manufactured in the Far East. The current COVID-19 pandemic has demonstrated that global supply becomes an issue in crisis situations, which has led to shortages for different APIs and intermediates. Therefore, a regional manufacturing of APIs and their intermediates is intensively discussed. The key question is: How this can be done in an economically useful way? Previous experience has demonstrated that key elements to reduce the cost per kg are process intensification and continuous manufacturing, both of which Microinnova has more than 15 years of experience in. Microinnova works on several projects for developing concepts and designing continuous processes to realize commodity APIs (>1.000 t/a) with significantly lower consumption of chemicals and energy, as well as decreased personnel costs.
Furthermore, the number of unit operations, solvent amounts and water demand can be significantly reduced. The first step of this is typically a detailed theoretical evaluation of the processes by investigation of its critical parameters by means of a literature study in combination with Microinnova’s broad competence of continuous manufacturing and process intensification. The core of Microinnova’s working procedure is a close interaction of the process development and engineering teams, leading to higher process capability, resulting in a higher product quality level. This leads to a first process flow diagram, including a first plant cost estimation. Dimensioned mass and energy balances, as well as waste and energy streams, enable a fundamental evaluation of the process costs and can be used as decision making tool. Afterwards, the continuous process will be developed. The verified process will be the base for the basic engineering, including a complete safety concept. The GMP-compliant Smart Manufacturing plant will be constructed and started up by Microinnova and will contain tools like model predictive control (MPC) and process analytical technology (PAT). The work is based on a standardized MIC internal scheme, developed from more than a hundred process development projects.