We routinely use Design of Experiments (DoE) for process optimization. Associated with single-use high-throughput bioreactors (such as µ24, ambr15, ambr250…), it sets up the path for better and faster process development.
These new technologies can lead to a better process knowledge together with an increased capacity.
The benefit of such tools will be illustrated through different case studies.
At first a screening platform grounded on a panel of optimized scale-down models, including selected media and conditions allows to efficiently identify best clones for further scale-up.
Case study for process optimization of an industrial process was conducted in a µ24 microbioreactor, process scaled-down at 3mL scale. Experimental reproducibility was checked at this scale then a DoE was conducted and optimum conditions successfully applied at an intermediate scale and then up to 1000L industrial scale demonstrating linear performance between newly established screening platform and industrial process.
The well characterized high-throughput scale-down culture systems, DoE and PAT approaches through in line biomass measurement enable us to rapidly select strain and culture conditions, perform linear transfer to industrial process, perform process tuning outside of the industrial equipment and facility environment, while still providing meaningful data and documentation.