Spray dried plasma manufactured from apheresis and whole blood derived plasma

BACKGROUND: Dried plasma is an attractive option when provision of frozen plasma is challenging. FrontlineODP™ system (Velico Medical) is a spray drying system producing a unit of spray dried plasma (SDP), in a blood bag, in around 30 min. This study evaluates coagulation parameters before and after drying, using two types of starting plasma: Whole blood (WB) derived, and apheresis derived. METHODS: A minimum of 15 units each of WB derived CPD-anticoagulated plasma and plasmapheresis (Aurora, Fresenius Kabi) sodium citrate-anticoagulated plasma were sampled and frozen within 12-18 h of venepuncture. Units were spray dried using the Velico FrontlineODP™ system. Following rehydration with sterile water, further samples were taken. All samples (pre drying, immediately post rehydration and 6 h post rehydration) were tested in parallel for a range of coagulation parameters, including thrombin generation, as well as biochemical parameters and bacterial contamination. RESULTS: All dried plasma units rehydrated in an average of 6 min. All coagulation parameters were within ±20% pre to post drying, except von Willebrand factor (vWF) activity and FXIII activity, which decreased by approximately 50% and 25%, respectively. Further investigation of vWF showed a change in the ratio of high and low molecular weight multimers. No bacterial contamination was detected in any of the units. SUMMARY/CONCLUSIONS: The FrontlineODP system can be incorporated into a standard blood service laboratory environment and successfully produce SDP with acceptable levels of coagulation proteins. Clinical data assessing SDP in a relevant patient population are now needed.