Spray dried plasma manufactured from apheresis and whole blood derived plasma
Lucy Bower, Sian Huish, Katarzyna Oleniacz, Matthew Ellington, Melanie J. Robbins, Tom Woolley, Jihae Sohn, Laura Green, Rebecca CardiganAbstract
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.