Retention of Coagulation Factors and Storage of Freeze-Dried Plasma

ABSTRACT Introduction Terumo BCT is developing a system to produce freeze-dried plasma product, Terumo’s (TFDP), that stored in rugged, light-weight plastic package suitable for field use, which retains stable level of specific coagulation factors and proteins within clinical range, when up 2 years at room temperature 4°C. Materials Methods Plasma frozen 24 hours phlebotomy (PF24) were thawed, sampled, individually lyophilized corresponding TFDP unit. Fresh (FFP) units pooled groups 10 (also sampled) lots TFDP. Each unit was reconstituted with water injection (WFI) tested pH, prothrombin time, activated partial thromboplastin V VIII, fibrinogen, protein C, S. Results compared PF24/FFP. Additional FFP pooled, divided generate each time point (1, 2, 3, 6, 12, 18, months, one 4°C 25°C) lyophilized. Postlyophilization, or 25°C, WFI, the listed above. Residual moisture content also tested. Coagulation factor activity ±20% Pooling standardized variation activities, ranges postlyophilization. The pH PF24/FFP required range. <2%. Conclusions process had no negative impact on activity. Input anticoagulant type did not affect quality. normalized variability negatively product months refrigerated temperatures. comparable It does require complex logistics time-consuming thawing. may be rapid treatment coagulopathies logistical advantages over