Implementation of buffy coat platelet component production: comparison to platelet-rich plasma platelet production

BACKGROUND: Buffy coat (BC) production of platelets (PLTs) has been successfully used in Europe for more than two decades. Currently, Canadian Blood Services is implementing the BC method. This article summarizes results of the validation testing performed to qualify the process of PLT production from whole blood and compares the quality of PLTs produced in routine production by either the PLT-rich plasma method (PRPPCs) or the BC method (BC-PCs). STUDY DESIGN AND METHODS: Validation data included variables used for routine quality control (QC; pH, PLT count, volume, sterility, residual white blood cell count) as well as nonroutine testing of PLTs for PLT activation, metabolic changes during storage, and PLT responsiveness to hypotonic shock and the extent of shape change induced by adenosine 5′-diphosphate. BC-PCs were tested on Days 1 and 6. QC of production runs included the same routine tests performed on Day 6. RESULTS: PLTs produced by the BC method during validation and pilot implementation met all Canadian Standards Association standards with respect to yield, volume, pH, and leukoreduction. Additional validation testing indicated a moderate level of PLT storage lesion development. In comparison to PRP-PCs, in vitro variables of BC-PCs, either pH in this study, or other markers compared to the literature were better, suggesting that BC-PCs have less evidence of productionrelated damage and improved PLT quality during storage. CONCLUSIONS: PLT concentrates produced from whole blood by the BC method after an overnight hold have laboratory variables suggestive of a higher quality than those concentrates produced by the PRP method. C anadian Blood Services undertook to change its method of component production from whole blood from the North American standard platelet-rich plasma (PRP) method to the buffy coat (BC) method of platelet (PLT) production. Developed by investigators in the Netherlands and Sweden in the mid-1970s, 1 the BC production method reverses the sequence of centrifugation steps compared to PRP. A hard spin is used initially to separate whole blood into three components: plasma, red blood cells (RBCs), and a BC layer. Using semiautomated extraction, the most common configuration uses a so-called top-and-bottom collection set in which plasma and RBCs are transferred to storage containers and the BC is left in the donation bag. This BC contains PLTs, white blood cells (WBCs), plasma, and some RBCs. ABO-matched BCs are pooled together with 1 plasma unit from one of the donors or 1 unit of PLT additive solution using a sterile docking device. The pooled BC is then given a soft spin, and the PRP is extracted with or without leukofiltration to produce a pooled PLT concentrate. Although both methods produce a PLT product, the products may have somewhat different in vitro characteristics. There is noticeable quality improvement in laboratory markers of BC-produced PLTs