PRP Quality Control: A Real-World Study

A multicentre study by BioSmartData, published in Pharmaceuticals (Q1), proposes a framework to characterise PRP composition based on 13,283 real-world analyses.

BioSmartData has just published a new scientific article in Pharmaceuticals, an international journal ranked in the first quartile (Q1), with an impact factor of 5.7 and indexed in PubMed and Scopus. The study, An Adaptable Quality Control Framework for Platelet-Rich Plasma as a Blood-Derived Product: A Multicenter Real-World Study, proposes a methodology to characterise the composition of platelet-rich plasma (PRP) and analyse its variability in routine clinical practice.

A study built on real-world data

The analysis brings together 13,283 haematological analyses linked to infiltrations administered to 5,339 patients across 35 private clinical centres in Spain. The data were collected during routine care, without additional interventions, and analysed in pseudonymised form under a framework approved by the Research Ethics Committee of the Balearic Islands.

Why PRP quality is a challenge

PRP is prepared from the patient’s own blood, close to the point of care. Its composition depends on patient factors, the preparation system and the protocol used at each centre. Existing classification systems help describe a preparation, but they do not allow routine monitoring of whether the product matches the intended profile, or which attribute explains a deviation.

What the study proposes

The article presents an adaptable quality control framework that includes an index from 0 to 100. This index summarises how closely each preparation matches a defined compositional profile based on three attributes: platelet enrichment and the residual ratios of white and red blood cells.

The framework is adaptable because the reference profile can change depending on the type of product a centre aims to obtain. It also always reports the index alongside each attribute separately, so it is clear which component deviates from the profile.

What the study observed

The study observed that PRP compositional profiles varied across centres and preparation systems, and that the attribute driving each deviation also differed from one group to another. According to the authors, this points towards reviewing specific processes, such as training, protocol execution, sampling or measurement, rather than ranking centres or devices.

What the study does not claim

The authors stress that the index is a research and process-monitoring tool. It is not a validated clinical predictor or a regulatory or manufacturer specification, and it should not be used to guide individual treatment decisions. An exploratory analysis of patients with knee osteoarthritis showed no consistent association between the index and clinical outcomes.

What this means for BioSmartData

This publication shows that data collected in routine clinical practice, when properly governed, can become peer-reviewed scientific research. It is tangible evidence of the value of our technology and strengthens our commitment to the medical community, institutions and the healthcare industry.

Special thanks

We would like to give special thanks to Pedro Martí Picó, lead author, for his dedication and rigour throughout the process. Thanks also to María Cayuela, Amrei Ewers and María Sanchez, to Diego Delgado and Dr Mikel Sánchez of MiKS Hospital, and to the participating clinical centres.

Read the full article in Pharmaceuticals

Source: Martí Picó P, Delgado D, Cayuela M, Sánchez M, Ewers A, Sanchez M. An Adaptable Quality Control Framework for Platelet-Rich Plasma as a Blood-Derived Product: A Multicenter Real-World Study. Pharmaceuticals. 2026;19(10):1609. doi:10.3390/ph19101609. Published 10 October 2026.

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