Spray drying of biopharmaceuticals: Stability and process considerations

Spray drying represents an elegant one-step process for producing biopharmaceutical formulations with unique particle characteristics. However, the full potential of spray drying of therapeutic/proteins/peptides has yet to be fully exploited. The reluctance of utilizing spray drying for formulation development may stem from the fact that the process oftentimes subjects the therapeutic actives to temperatures in excess of 100 degrees C, which is a concern for thermally labile drugs as spray drying was performed primarily on co-current spray dryer in a single-stage mode. In this review we discuss the respective dehydration mechanisms of spray drying and the appropriate formulation strategies that can be taken to minimize detrimental effects on biomolecules.