Pharmaceuticals
An Adaptable Quality Control Framework for Platelet-Rich Plasma as a Blood-Derived Product: A Multicenter Real-World Study
Por Pedro Martí Picó, Diego Delgado, María Cayuela y 3 más.
Contenido en inglés
Resumen
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.



