Abstract

YıLMAZ, Habibe et al. System Suitability Testing of the Method Developed to Measure the Active Concentration of a Fab Fragment Via Surface Plasmon Resonance. J. Mex. Chem. Soc [online]. 2021, vol.65, n.4, pp.491-500.  Epub Feb 28, 2022. ISSN 1870-249X.  https://doi.org/10.29356/jmcs.v65i4.1527.

SPR methods are increasingly accepted by the biopharmaceutical industry in quality control (QC), R&D and clinical research. 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. 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. 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. High amounts of anti-FAB1 were captured onto sensor chip surfaces via biotin/neutravidin interaction. The unknown concentration of FAB1 measured via calibration curve dependent concentration measurement. Controls were run between unknown samples to check the reliability of the method. The standard four-parameter logistic equation was used to determine the unknown concentration. CV % of samples and Difference % of controls form standards were calculated from obtained data. The CV % and Diff. % values were less than or equal to 10 % at each parameter. The 100 % level of unknown sample measured as 105 %. Obtained CV % values and repeated analyses showed that the system and method are suitable for the concentration analysis of the FAB1 fragment. The system suitability parameters evaluated in the study can be applied for all SPR analyzes.

Keywords : Fab fragment; concentration measurement; surface plasmon resonance; biopharmaceutics; system suitability testing.

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