Extractables And Leachables Assessment For Single-Use Systems In Intensified And Continuous Bioprocesses

By Armin Hauk, Ina Pahl, Roberto Menzel, and Nelly Montenay, Sartorius

Efforts to introduce process intensification and continuous processing in biopharmaceutical manufacturing stem from the need to boost production capacity in a resource-efficient, sustainable, and economically viable manner. This goal can be achieved by optimizing the manufacturing processes for drug substances and products using single-use solutions. However, the dynamic nature of the production environment necessitates additional considerations regarding the qualification of process equipment. One critical aspect to address is the temporal development of leachables related to process equipment. Leachables are substances that can migrate from the equipment into the product over time, potentially affecting product quality and safety. To manage this, specifically developed algorithms can be employed to predict the temporal development of leachables under kinetic conditions. These algorithms can simulate how leachables evolve to allow for proactive measures to be taken to mitigate their impact.

By continuously monitoring and adjusting the flow of production media, manufacturers can ensure that the process remains stable and that the quality of the final product is maintained. Explore how this approach not only enhances production efficiency but also contributes to the overall sustainability and economic viability of biopharmaceutical manufacturing.