Quality Assessment of Established and Emerging Blood Components for Transfusion

Abstract

Blood is donated either as whole blood, with subsequent component processing, or through the use of apheresis devices that extract one or more components and return the rest of the donation to the donor. Blood component therapy supplanted whole blood transfusion in industrialized countries in the middle of the twentieth century and remains the standard of care for the majority of patients receiving a transfusion. Traditionally, blood has been processed into three main blood products: red blood cell concentrates; platelet concentrates; and transfusable plasma. Ensuring that these products are of high quality and that they deliver their intended benefits to patients throughout their shelf-life is a complex task. Further complexity has been added with the development of products stored under nonstandard conditions or subjected to additional manufacturing steps (e.g., cryopreserved platelets, irradiated red cells, and lyophilized plasma). Here we review established and emerging methodologies for assessing blood product quality and address controversies and uncertainties in this thriving and active field of investigation.

Characteristics of Extracellular Vesicles in Red Blood Concentrates Change with Storage Time and Blood Manufacturing Method

“…Although regulatory standards are applied for the processing and storage of RCCs to ensure the safety of the blood products, a number of product quality characteristics have been shown to be impacted by the manufacturing method and hypothermic storage [3,22,31,48]. Currently, the role that the storage duration may play on the quality of blood products and transfusion outcomes has been the focus of several studies [22,35].…”

“…Currently, the role that the storage duration may play on the quality of blood products and transfusion outcomes has been the focus of several studies [22,35]. Variability exists within the blood products themselves [48,49], which may contribute to the storage lesions and adverse clinical outcomes. The blood component manufacturing processes and donor characteristics have emerged as major elements to explain some of the variability and conflicting clinical observations detected amongst blood products [22,48,50].…”

“…Variability exists within the blood products themselves [48,49], which may contribute to the storage lesions and adverse clinical outcomes. The blood component manufacturing processes and donor characteristics have emerged as major elements to explain some of the variability and conflicting clinical observations detected amongst blood products [22,48,50]. Here, we contribute to the current understanding on the impact of blood manufacturing methods and hypothermic storage duration on the characteristics of different subpopulations of EVs and in vitro quality parameters of RCCs produced by RCF and WBF processing methods.…”

“…However, it is important to mention that it is not yet clear whether these findings and differences observed are due to the differences in manufacturing methods or due to other variables such as donor characteristics. Although donor factors such as sex and age may influence RCC products during storage [48], the main focus of this project was to understand how the quality of RCC products was affected by the manufacturing process chosen and storage duration. Further comprehensive studies are needed to understand the role of donor factors, storage duration, and blood manufacturing processes on patient outcomes.…”

Cold storage of platelets in platelet additive solution: an in vitro comparison of two Food and Drug Administration–approved collection and storage systems

“…This short shelf life, enforced due to bacterial growth concerns, causes a chronic shortage in PLT inventories. RT PLTs also decline in hemostatic function and metabolism and release proinflammatory mediators during storage . As a result, alternative methods of storage to extend PLT function and prolong shelf life are needed.…”