Traceability of products and guide for batch definition in integrated continuous biomanufacturing

Abstract

AbstractBACKGROUNDA major improvement in biomanufacturing will arise with the transition from batch processing to continuous processing. Two important challenges to address in this change are batch definition and the ability to trace raw material through the process.RESULTSWe used an established simulation of a process train to compare the conventional batch definition based on a fixed time to a new batch definition method based on the greatest common divisor (GCD) of the time period of the unit operations. We successfully demonstrated that, by using the new concept based on GCD, we will have a constant periodic concentration of product. With this basis, we can define batches in a continuous process, which will lead to higher control over the process, and we will be able to trace the material through the process.CONCLUSIONWe achieved better control over the process using the batch definition based on the GCD method. In comparison to collecting the outlet products over arbitrary hours or days, collecting the product based on a section using the GCD method meets the criteria for knowing the residence‐time distribution of the process, as advised by regulatory authorities. This method can be used in a continuous process or a hybrid process in which there are only a few continuous unit operations along with batch process operations. © 2021 The Authors. Journal of Chemical Technology and Biotechnology published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry (SCI).