Platelet membrane-coated nanoparticles: Bioengineering principles, quality control, and translational opportunities.

Platelet membranes (PMs) are increasingly explored as bioinspired coatings for nanoparticles (NPs), providing improved immune evasion, prolonged circulation, and disease-homing properties that enhance targeted drug delivery. Unlike conventional NPs that rely mainly on passive targeting, PM-coated systems expose platelet surface markers such as CD47, GPIb, and P-selectin, enabling vascular adhesion and selective localization to tumors or thrombi. PM-NPs are thus increasingly regarded as promising carriers for oncology, cardiovascular, and infectious disease therapies. This review introduces the various bioengineering principles underlying PM-NP fabrication, including points to consider for platelet sourcing, membrane isolation, and coating strategies. Achieving reliable quality control (QC) and reproducibility depends on rigorous assessment of critical formulation variables, including nanoparticle size, surface charge, and the preservation of functional membrane proteins. The implementation of scientific approaches and regulatory standardization frameworks, such as the Minimal Information for Studies of Extracellular Vesicles guidelines, and Food and Drug Administration/European Medicines Agency (FDA/EMA) regulatory expectations, is critical to establish reproducibility and facilitate regulatory acceptance of PM-NP technologies, guiding their advancement toward clinical-grade production. Furthermore, we highlight translational opportunities and the complementary potential of platelet-derived extracellular vesicles, which share similar surface markers, yet offer intrinsic nanoscale size, endogenous bioactivity, and improved stability. By integrating robust engineering design with standardized QC practices, PM-NPs can progress from laboratory research to clinically viable therapeutics, establishing a relevant benchmark for future cell membrane-based nanomedicines.