Support of Scale-Up and Technical Transfer Through Understanding Equipment for Lyophilization

Formulation and process development for injectable products are typically conducted at laboratory-scale. Laboratory-scale equipment is useful and necessary during development when there is little technical information available and especially when the active pharmaceutical ingredient (API) is in short supply. 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 be differences in design of lyophilizers at laboratory-scale and at full-scale and also between full-scale equipment at different manufacturing sites. In addition, laboratoryscale studies are often conducted using lyophilizers having 0.43 m2 product chambers and this must increase in scale to lyophilizers equipped with 19.95 m2 product chambers or larger. The increase in size and equipment design can affect heat transfer within the lyophilizer and can affect the equipment capability. These factors can greatly affect the success of scale-up and technical transfer.