文摘
Human dialyzable leukocyte extracts (DLEs) are heterogeneous mixtures of low-molecular-weight peptides that modulate immune responses in various diseases. Due their complexity, standardized methods to identify their physicochemical properties and determine that production batches are biologically active must be established. We aimed to develop and validate a size exclusion ultra performance chromatographic (SE-UPLC) method to characterize Transferon鈩? a DLE that is produced under good manufacturing practices (GMPs). We analyzed an internal human DLE standard and 10 representative batches of Transferon鈩? all of which had a chromatographic profile characterized by 8 main peaks and a molecular weight range between 17.0 and 0.2 kDa. There was high homogeneity between batches with regard to retention times and area percentages, varying by less than 0.2% and 30%, respectively, and the control chart was within 3 standard deviations. To analyze the biological activity of the batches, we studied the ability of Transferon鈩?to stimulate IFN-纬 production in vitro. Transferon鈩?consistently induced IFN-纬 production in Jurkat cells, demonstrating that this method can be included as a quality control step in releasing Transferon鈩?batches. Because all analyzed batches complied with the quality attributes that were evaluated, we conclude that the DLE Transferon鈩?is produced with high homogeneity.
