There are few challenges when increasing the scale of production for a solution formulation, but the challenges drastically increase when the formulation is intended for lyophilization. There can, for example, be differences in design of lyophilizers at laboratory-scale and at full-scale and also between full-scale equipment at different manufacturing sites. Considering the differences in equipment design and capability will aid in the scale-up and technical transfer of new processes from laboratory-scale to full-scale and in transfers between manufacturing sites.
