Lyophilization development's main driver is to improve the stability profile for therapeutic proteins. In the traditional therapeutic market, liquid products have dominated the market share. However, as the patient population and therapeutic targets continue to change; lyophilized products may begin taking a share of the market. The main causes for stealing market share are around the advantages that a lyophilized product achieves. These include the ability to deliver high doses (> 1mg per kg (mpk)), the potential for room temperature storage allowing patient convenience, and easier, more cost effective, worldwide distribution. For a successful lyophilized product, one must understand critical process parameters (CPPs) that allow scale-up from bench-top to full scale manufacturing (i.e. freezing rate, primary and secondary drying, pressure, etc). These CPPs will impact critical quality attributes (CQAs) such as moisture stability. The following presentation will discuss factors that should be considered when choosing lyophilization over liquid formulations and the critical lyophilization parameters which should be understood, monitored, and controlled.