How to Link Pilot Scale Data to PPQ Planning

The initial signs of complications during the scale-up from lab to pilot scale were detected when batches in the pilot phase demonstrated variability in quality attributes. During routine testing, discrepancies…

How to Link Pilot Scale Data to PPQ Planning

During the pilot batch development phase, operators reported unusual viscosity changes of the fermentation broth that were not observed during lab scale testing. Quality control (QC) personnel detected deviations in…