Procress Development

Freeze-drying, often called lyophilization, has become a standard process in the pharmaceutical industry for the manufacturing of biologically active substances. Lyophilization offers several benefits including extended stability and simplified storage and shipping but there are limitations due to its high cost in capital and energy, and long processing time. In addition, there are challenges in selecting the process parameters such as time, drying temperature, pressure (vacuum), and component concentration for the lyophilization process. All these parameters must be optimized to: (i) achieve full recovery of activity and complete reconstitution of the often-labile drug, (ii) acceptable appearance of the freeze-dried cake, and (iii) good storage stability.