Biopharmaceutical companies are facing major challenges today, including rising drug manufacturing costs and lower production volumes related to unpredictable demands. To achieve the necessary reductions in both costs of goods (CoG) and infrastructure and operational costs, biopharmaceutical manufacturers integrate process intensification strategies into their production schemes. Novasep has embedded specific features into its BioSC™ platform to enable and accelerate process intensification (two key examples being viral inactivation steps management and in-line buffer preparation). BioSC Predict, Exclusive Simulation and Optimization Software:…
Author Archives: Jérôme Chevalier
Control Strategy in Continuous and Intensified Bioprocessing
Pharmaceutical companies take several factors into account when deciding whether to switch from established batch processes to better performing ones, including continuous processing. Such issues include the need to cut cost of goods (CoG), improve product quality consistency, increase process robustness, prevent human error by implementing automation, and so on. However, some challenges remain for some companies integrating these new ways of processing into a current good manufacturing practice (CGMP) environment. One issue is the adaptation of a quality management…