Batch to Continuous Technology: The Journey from Laboratory to Pilot Scale for DS Manufacturing
26th September 2022 | 10:00am EST / 7:00am PST / 3:00pm BST / 4:00pm CET | Jörg Sedelmeier, Platform Leader: Continuous flow technology (Principal Scientist) at Roche |WATCH FOR FREE
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.
Presented by Jörg Sedelmeier, Platform Leader: Continuous flow technology (Principal Scientist) at Roche
Jörg Sedelmeier, born 1977 in Freiburg (Germany), studied synthetic organic chemistry at the Albert-Ludwig University in Freiburg and conducted his PhD thesis in the group of Professor Bolm at the RWTH Aachen (Germany) in the field of sulfoximines and asymmetric metal catalysis. After a post-doctoral stay in Professor Ley’s group at University of Cambridge (UK) focusing on organic syntheses in continuous flow mode, he started his professional career as a process chemist at Novartis (Switzerland) in the Chemistry & Analytical Department in 2010. Here he was involved in process development, scale-up to pilot and plant scale, laboratory automation and continuous flow technologies. In 2017 Joerg became a Novartis Fellow. In 2019 he moved to F. Hoffmann-La Roche Ltd. (Switzerland) and is now platform leader for continuous flow technologies in Synthetic Molecules Technical Development. Jörg (co)-authored more than 31 publications and patents and won several company-internal science awards.