Batch to Continuous Technology: The Journey from Laboratory to Pilot Scale... - ERP Spain.com - España y América Latina

Batch to Continuous Technology: The Journey from Laboratory to Pilot Scale for DS Manufacturing The presentation outlines a case-study in establishing the operational space of a Grignard reaction in a series of continuous stirred tank reactors (CSTRs). The development of a laboratory scale continuous flow process for the manufacture of a key intermediate of the pharmaceutical product Ipatasertib for the treatment of metastatic castration-resistant prostate cancer and triple negative metastatic breast cancer involves flow and batch unit operations. In a head-to-head comparison between the continuous and batch processes, the former was clearly superior as it gave a higher yield (81% vs 63%) of the product and better reaction control for handling the unstable reaction intermediates. Short residence times, accurate temperature and pH control and steady concentration profiles enabled the synthesis of product in excellent and invariable purity The gathered data and experiences from this study was crucial for guiding the decision making process in order to design a suitable pilot setup for the subsequent cGMP campaign.