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Atmospheric Spray Freeze Drying (ASFD)

Atmospheric Spray Freeze Drying (ASFD) is a new, disruptive technology that produces a fine powder from drug product.
Categories
Drug product
Equipment and Supplies
Project status
100% Completed

Industry Need

  • Recipient of funding for NIIMBL Project Call 5.1, which involves projects that help determine the variability associated with key product attributes for therapeutic proteins such as recombinant monoclonal antibodies while investing in state-of-the-art analytical instrumentation infrastructure that will be available across our community to support NIIMBL-related activities in the future in this and related technical areas. 

 

Solution

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. 


Outcomes and Impacts

Availability of state-of-the-art analytical instrumentation infrastructure across the community to support NIIMBL-related activities in the future

Updates, Related Publications, and Deliverables

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Project Lead

Aerosol Therapeutics

Aerosol Therapeutics

Participating Organizations

NIIMBL

NIIMBL