![]() ![]() % values were less than or equal to 10 % at each parameter. CV % of samples and Difference % of controls form standards were calculated from obtained data. The standard four-parameter logistic equation was used to determine the unknown concentration. Controls were run between unknown samples to check the reliability of the method. The unknown concentration of FAB1 measured via calibration curve dependent concentration measurement. High amounts of anti-FAB1 were captured onto sensor chip surfaces via biotin/neutravidin interaction. To contribute to the alleviation of the deficiency in this matter, we developed a system suitability testing of an SPR-based active concentration measurement method using Fab-fragment as a model. System compliance must be demonstrated with certain tests in order, for the method validation to be ensured, as agreed by the scientific community and the industry, and specified in the guidelines. However, there are few reports on method validation and system suitability testing (SST), in particular on concentration determination methods related to the potency of the drug. SPR methods are increasingly accepted by the biopharmaceutical industry in quality control (QC), R&D and clinical research. ![]()
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