Vitalant Research Institute, Denver, CO Denver, Colorado, United States
Background/Case Studies: Whole blood (WB) collection and processing is critical to maintaining a sustainable blood supply. In the US platelets (PLT) are predominantly collected via apheresis, and the Platelet Rich Plasma (PRP) method (top & top) is the only approved WB process in the US to manufacture platelets (PLT). Other countries use the buffy coat (BC) method (top & bottom) for the separation of WB into Red Blood Cells (RBC), plasma, and BC layers. BCs are pooled to produce leukoreduced PLTs in additive solution (PAS). Adopting this approach in the US could maximize the use of the existing WB donor pool, buffer and stabilize PLT inventory and mitigate PLT shortages. This study was conducted at Vitalant, one of the largest US blood centers, in collaboration with Macopharma.
Study
Design/Methods: ABO-matched WB units were collected and transported at room temperature (RT). Within 24 hrs of collection, WB was transferred to a collection bag with DEHT plasticizer (Macopharma) and separated into RBCs, plasma, and individual BCs using an automatic press (Macopress Smarter). RBCs were resuspended in additive solution (PAGGSM), leukoreduced and moved to 4˚C storage for 42 days. BCs rested for a minimum of 2 hrs at RT, and 5 ABO compatible BCs were pooled in PAS-E (SSP+) using a pooling set and a sterile connection device (Maconnect) that makes 6 sterile connections simultaneously. The BC pool was centrifuged, separated and leukoreduced using Macopress Smarter. PLT concentrates were stored for 7 days and sampled on days 1, 5, and 7 for in vitro quality.
Results/Findings: WB (N=68) was collected in CPD and processing started within 24 hrs (range 13.2-23.5 hrs) of collection. RBC recovery (vol/vol) and PLT yield was on average 97±1% and 3.99x10E11, respectively. Swirling was observed throughout storage. Component characteristics and in vitro storage parameters are summarized in the Table below.
Conclusions: WB processing after a 24-hrs hold at RT with the top & bottom DEHT plasticizer (non-DEHP) bags, coupled with automated separation and pooling technologies, demonstrates acceptable component quality and compliance with leukoreduction standards. RBCs suspended in PAGGSM maintained on average low hemolysis levels throughout storage. The pooled PLT concentrates in SSP+ showed high PLT yields, low residual leukocytes, and stable pH levels throughout 7 days storage, ensuring suitability for transfusion. The BC method optimizes WB operations and provides a sustainable solution to enhance PLT availability and resource efficiency.
