QUALITY CONTROL EVALUATION OF LEUCODEPLETED PLATELET CONCENTRATES PREPARATION WITH BUFFY COAT POOLING METHODE IN GSH BLOOD BANK IN SAO PAULO, BRAZIL

Abstract

Objective: To evaluate the quality of leukodepleted platelet concentrates (LDPC) obtained from the buffy coat pooling method from the whole blood (WB) collected and processed in GSH blood bank Sao Paulo (SP), during April - June 2024, verifying local and the European Directorate for the Quality of Medicines & HealthCare (EDQM) Blood Guide. Material and methods: WB units were collected using Top and bottom (T&B) quadruple CDP/SAGM with in-line filter bags (n = 84, 450 ml), (LQT610L® system Macopharma; France) in GSH Blood Bank, SP, Brazil, between April - June 2024. WB was centrifuged on day 0 at 3,500 rpm (Sorval RC 3C Plus) for 15 min. Blood components were separated with a Fractiomatic Plus 2 blood separator (Grifols, Spain). After T&B processing, 4 Buffy Coats (BCs) (ABO compatible, overnight rest) were pooled and mixed with 1 plasma unit, using a BC pooling system with in-line filtration (TRV806L, Macopharma) and sterile connector device (TSCD, Terumo, Japan). BC Pools were centrifuged at 1450 rpm × 6:00 min and separated to obtain leukodepleted platelet concentrates (LDPC) (n = 21), which were measured for final volume, platelet count after two hours of resting (Cell Dyn- Emerald, Abbot), residual leukocytes (rWBC) (Nageotte camera, Blaubrand), pH (potentiometer) and microbiological culture (manual). Results: Volume values of LDPC suspended in plasma were 333.47 ml (198 – 374 ml), with platelet recovery on day 1 of 3.01×1011/unit (2.05 – 4.25), aligned with the local requirements (> 3.0 × 1011/unit). Also, the obtained platelet recovery percentages are within the specified limits: 77% average (62% – 108%). For leukoreduction, the results meet the terms with local and international (EDQM) requirements ( 6.4). Finally, 100% of microbiological cultures were negative, ensuring the safety of the preparation method. Discussion: The widespread adoption of the buffy coat (BC) method for platelet preparation is evident in numerous countries. The present evaluation demonstrated that this type of implementation could be accomplished in Brazilian blood centers. Leukodepleted platelet concentrates (LDPCs), produced during the validation phase, adhered to local and European standards, specifically the European Directorate for the Quality of Medicines (EDQM, 2023), regarding platelet count and leukocyte reduction. While it is well-recognized that Brazil predominantly use the ‘top and top’(T&T) method for producing platelet-rich plasma (PRP), the BC pooling approach presents a viable alternative to optimizes resources, requiring merely four donors to yield a therapeutic platelet dose, and ensuring superior quality, attributable to the leukodepletion filter and the integrity of a closed system. Conclusion: The Thromboflex® TXP system is a method for producing LDPCs from BC pooling that meets the local and EDQM standards. Quality indicators confirmed the production of international standardized platelet products, establishing whole blood-sourced, buffy coat pooled platelets as a reliable method to ensure the blood supply at the GSH blood bank.