Abstract / Summary
Background and Objectives: Platelet-rich plasma (PRP) composition and activity vary with patient-related factors, medication exposure, and preparation procedures. We developed an adaptable manufacturing quality control score (QC-Score) framework and retained clinical outcomes as a secondary exploratory layer. Methods: This retrospective multicenter study included 13,283 hematological analyses associated with administered infiltrations. Its product-profile alignment index (PPAI; 0–100) summarizes the alignment of platelet enrichment and residual white blood cell (WBC) and red blood cell (RBC) ratios with a study-defined compositional profile. The criteria are research proxies and not manufacturer or regulatory release limits. Results: The full PPAI was reportable in 8937 analyses and a platelet-only partial index in 404 analyses. The median full PPAI values for Systems A, B, and D were 74.6, 90.6, and 48.8, and complete-case conformance to the frozen study-defined benchmark was 9.8%, 15.8%, and 10.2%, respectively. System C was evaluated on platelet enrichment only. Modeling the recorded final-product WBC and RBC zeros as residual concentrations of 0.01 changed nine individual PPAI values but no system median or conformance count. Center–system patterns were heterogeneous. Secondary exploratory Knee Injury and Osteoarthritis Outcome Score (KOOS) analyses were sensitive to incomplete questionnaire handling and showed no consistent association with the PPAI. Conclusions: The QC-Score framework and PPAI support product characterization and targeted process investigation. Their operational proxies are neither manufacturer release limits nor regulatory specifications, and the PPAI was not validated as a clinical predictor.