Spray: single-donor plasma product for room temperature storage

Area of Science:

• Biotechnology
• Hematology
• Materials Science

Background:

• Spray-drying is widely used in various industries but not yet for human blood products.
• Spray-dried protein products exhibit excellent stability at room temperature.
• This study explores the application of spray drying to human plasma.

Purpose of the Study:

• To investigate the feasibility of spray drying human plasma.
• To assess the stability and recovery of proteins and coagulation factors after spray drying and reconstitution.
• To compare the efficacy of different reconstitution fluids.

Main Methods:

• Human plasma units were spray-dried and stored at room temperature for 48 hours.
• The spray-dried plasma was reconstituted using either 1.5% glycine or deionized water.
• Assays were performed to measure chemistry analytes and coagulation factor recovery, with fresh-frozen plasma as control.

Main Results:

• Reconstitution was achieved within 5 minutes for both groups.
• High recovery rates (≥96%) were observed for total protein, albumin, IgG, IgA, and IgM.
• Glycine reconstitution yielded superior recovery of clotting factors (72%-93%) compared to deionized water, though Factor VIII recovery was 58%.

Conclusions:

• Spray-dried plasma products successfully recovered proteins and coagulation factors in physiologic quantities.
• Further optimization of spray-drying and reconstitution may enhance recovery rates.
• Spray drying presents a promising method for creating a stable, easily transportable, and rapidly reconstitutable human plasma product.