Process understanding | 3L, 7L, 15L | CPPs and CQAs | modeling mixing | virtual experiments | pilot plant test runs | unique manufacturing strategies
Scale-up design is at the heart of what our bioengineering team do to support your medicines journey to manufacturing. From the earliest stages of upstream and downstream processes development, we strive to select cell lines, develop media, select separation technology, and choose chromatography resins that will make the mass production of your medicine possible.
We work in glassware to critically understand your process, leveraging a vast bioanalytical suite of technologies, before determining a scale-up strategy that gets your bioprocess into a bioreactor at the 3L, 7L and 15L scales. From here we assess the process for scalability, evaluating the relevant CPPs and developing the analytical methods to deliver the information needed to target the relevant quality attributes. We model mixing regimes at feed locations and determine shear rates that may impact the product yield. We also deploy PAT tools, upstream and downstream, that can monitor the metabolic flux or reveal protein aggregation.
From this position of deep process knowledge, we prepare to move to larger scales, ultimately targeting test runs at the 250L scale in our single-use pilot plant. These runs confirm performance and help make optimizations that will support a fast and effective transfer to commercial manufacturing. For many bioprocesses, the ultimate manufacturing strategy involves non-standard equipment sets that must be designed and built from the ground up. We support this effort running virtual experiments on SUBs and wave bags so challenging manufacturing introductions can happen right first time under challenging timelines.