title: Spray: single-donor plasma product for room temperature storage.
abstract: BACKGROUND
  Spray-drying techniques are commonly utilized in the pharmaceutical, dairy, and animal feed industries for processing liquids into powders but have not been applied to human blood products. Spray-dried protein products are known to maintain stability during storage at room temperature.
  
  
  METHODS
  Plasma units collected at the donor facility were shipped overnight at room temperature to a processing facility where single-use spray drying occurred. After 48 hours' storage at room temperature, the spray-dried plasma product was split in two and rehydrated with 1.5% glycine or deionized water and assayed for chemistry analytes and coagulation factors. Matched fresh-frozen plasma was analyzed in parallel as controls.
  
  
  RESULTS
  Reconstitution was achieved for both rehydration groups within 5 minutes (n = 6). There was no significant intergroup difference in recovery for total protein, albumin, immunoglobulin (Ig)G, IgA, and IgM (96% or higher). With the exception of Factor VIII (58%), the recovery of clotting factors in the glycine reconstituted products ranged from 72% to 93%. Glycine reconstitution was superior to deionized water.
  
  
  CONCLUSIONS
  We documented proteins and coagulation activities were recovered in physiologic quantities in reconstituted spray-dried plasma products. Further optimization of the spray-drying method and reconstitution fluid may result in even better recoveries. Spray drying is a promising technique for preparing human plasma that can be easily stored at room temperature, shipped, and reconstituted. Rapid reconstitution of the microparticles results in a novel plasma product from single donors.
authors: Department of Transfusion Medicine, Clinical Center, National Institutes of Health, Bethesda, Maryland, USA. garrett.s.booth@vanderbilt.edu
authors: Garrett S
authors: GS
authors: Booth
authors: Jay N
authors: JN
authors: Lozier
authors: Khanh
authors: K
authors: Nghiem
authors: Douglas
authors: D
authors: Clibourn
authors: Harvey G
authors: HG
authors: Klein
authors: Willy A
authors: WA
authors: Flegel
mesh_terms: D001782:Blood Donors; D001793:Blood Preservation; D005612:Freeze Drying; D006801:Humans; D010949:Plasma; D013696:Temperature