Atmospheric Spray Freeze Drying (ASFD)

Atmospheric Spray Freeze Drying (ASFD) is a new, disruptive technology that produces a fine, light flowing powder from solutions of biopharmaceutical materials. Atmospheric pressure is maintained throughout the process reducing costs and sterility risks inherent in the current drying technologies. Initial proof of concept testing of mAbs, proteins, and cells, after drying, met post reconstitution standards for reconstitution time, moisture, yield, aggregates, and cell activity in the laboratory setting. 

Based on Aerosol’s previous experience and testing, the original Gen 2.0 equipment will be upgraded during this first segment of the project to function as more sensitive research instrument that will be easier to operate. During this part of the project, the newly enhanced Gen 3.0 equipment will be utilized to optimize the ASFD process drying conditions.  

Testing during this period will include: 

1. testing the operation of the Gen 3.0 equipment, 
2. optimizing process drying temperatures and process powder thickness on the filter, 
3. proving a uniform particle size (40 micron) with a narrow range in distribution of size, and 
4. proving powder quality post drying.