Abstract

Transfusion medicine is a clinical discipline characterized by one of the most advanced quality management systems, which is structured so as to assure the production of blood components and raw materials, for biopharmaceutical fractionation, that are safe, efficient and effective.During the production, pathogen inactivation and storage processes there is the risk of changes in the integrity of blood components, especially at the protein level. These changes could be the cause of some of the negative effects of transfusion therapy. It is therefore a major challenge to identify significant alterations of these products, and, in this context, proteomics can play a potentially relevant role in transfusion medicine to assess the protein composition of blood‐derived therapeutics, particularly for identifying modified proteins.Proteomics can also provide a more detailed understanding of the proteins found in plasma derivatives, with particular regard to peptide and protein changes related to the various procedures used for protein purification and pathogen inactivation during the modern plasma industrial factionation. The latter could cause protein modifications and/or degradation and neoantigen production, with the potential to induce adverse effects in recipients.At present, blood component quality control is mainly focused on standardized quantitative assessment, providing relatively limited information about products. Proteomics allows a comprehensive study of protein modifications, qualitative and quantitative analysis, and high‐throughput protein identification. Moreover, being the only tool to evaluate structural changes in proteins (or their degradation products) after their manipulation, and having the capacity to identify many new proteins, proteomics seems to be the most promising tool for global quality assessment and possible improvement of the production process of blood components and plasma derivatives. It can also provide comprehensive information about possible contaminants and neoantigens that may influence the immunogenic capacity of blood‐derived therapeutics.

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