Analytical approaches to the quality assurance of leukocyte-reduced blood components: Impact of strategy on product quality/new technology for leukocyte enumeration

Abstract

The medical benefits of leukocyte-reduced blood components have been well documented. Standards for the labeling of these products have been defined. Manufacturers of leukocyte-reduced blood components must demonstrate compliance with the Guidelines and Requirements for these products published by CBER. The implementation of these requirements by a manufacturer could have a significant impact on the quality of product. It is critical that both process control and product quality control be addressed by the strategy established by the manufacturer for these products. An alternative method for the enumeration of residual leukocytes in these blood components has been described. With this method, accurate enumeration of leukocyte concentration can be obtained with simple processing steps and automated analysis.