RÉSUMÉ
The high performance liquid chromatography-fluorescence micelle assay (HPLC-FMA) method for the content determination of polysorbate 80 in monoclonal antibody drugs was validated to study its applicability and transferability between various laboratories, and the feasibility to be included in the Chinese Pharmacopoeia. Both J.T. Baker and Nanjing Well-sourced polysorbate 80 was used in the collaborative validation of polysorbate 80 content analysis in seven different laboratories. The results show that when the protein concentration was no more than 20 mg·mL-1 and the concentration of polysorbate 80 ranged from 0.05 to 0.5 mg·mL-1, the method had good specificity. The recovery rates of the spiked samples ranged from 92.20% to 117.70% for J.T.Baker and from 93.90% to 117.20% for Nanjing Well. The intra-laboratory precision (%RSD) was less than 4.30% for J.T. Baker, and less than 2.60% for Nanjing Well, while the overall precision was less than 5.45% for J.T. Baker, and less than 6.70% for Nanjing Well. The linear correlation coefficient was more than 0.98 for J.T. Baker and more than 0.99 for Nanjing Well. The results of the collaborative validation prove that the HPLC-FMA method has good accuracy, precision, linearity, and specificity, and could be used for release control analysis of polysorbate 80 content in monoclonal antibodies across different laboratories.
RÉSUMÉ
Microbial fuel cell ( MFC ) is a type of energy device in which exoelectrogens are harnessed for directly converting the chemical energy of organic matter into electric energy. In addition to researches on the development of high-performance MFC, we have witnessed a rapid progress in the analytical application of MFCs. The MFC-based biosensors are simple and easy to operate, and they can also be used to monitor target online without external power sources, thus attracting more and more attention. Here, we summarize and discuss the progress on using MFCs for measuring biological oxygen demand ( BOD ) , volatile fatty acids, pollutant and toxic compounds, microbial activities and other substances. Furthermore, the design principle of MFC-based biosensors is clarified. The outlook and future prospect of MFC-based biosensors are also discussed in the end.