WP7: Final process
In workpackage ''Final process'' we will implement a fully integrated manufacturing platform based on continuous chromatography in combination with single-use disposable techniques for all unit operations of DSP on small production scale together with incorporation of advanced analytical tools. Modelling will be executed and used at decision points within the WP. After fixing the process at lab-scale, confirmation runs on final scale will follow with the aim to prove that the process is robust, yielding product of the desired quantity and quality. The process consistency will be shown using three confirmation batches on final scale. WP7 is led by LEK Pharmaceuticals.