Process Analytic Technologies (PAT) for Biologics

The development of biologic drugs for cancer treatment often requires formulations that must be lyophilized to produce stable drug products. The process of developing a drug formulation and freeze-drying process begins with laboratory experiments followed by scaled-up to pilot and production scale lyophilizers. A major challenge during early formulation and lyophilization process development is the cost and limited supply of active pharmaceutical ingredient available for development and the lack of a representative small scale lyophilizer that emulates a production scale dryer. Current laboratory dryers hold hundreds of vials and their operation and product drying behavior with just a few vials is different than with a full load of vials due to highly atypical radiation heat transfer. The process information gathered drying a few vials in a standard laboratory dryer is relatively useless. The goal of this Phase I SBIR program is to design , fabricate, test, and apply a mini-lyophilizer that dries one to seven product vials under heat and mass transfer conditions typically encountered in larger production freeze dryers. The mini lyophilizer will be outfitted with process analytic technology tools that enable the use of scientific and engineering principles for successful process scale up and economically viable drug product manufacturing.