| Autor: |
Kang DH; Biologics Research Division, Pharmaceutical and Medical Device Research Department, National Institute of Food and Drug Safety Evaluation, Cheongju 28159, Republic of Korea., Yun SY; Biologics Research Division, Pharmaceutical and Medical Device Research Department, National Institute of Food and Drug Safety Evaluation, Cheongju 28159, Republic of Korea., Eum S; Biologics Research Division, Pharmaceutical and Medical Device Research Department, National Institute of Food and Drug Safety Evaluation, Cheongju 28159, Republic of Korea., Yoon KE; Biologics Research Division, Pharmaceutical and Medical Device Research Department, National Institute of Food and Drug Safety Evaluation, Cheongju 28159, Republic of Korea., Ryu SR; Biologics Research Division, Pharmaceutical and Medical Device Research Department, National Institute of Food and Drug Safety Evaluation, Cheongju 28159, Republic of Korea., Lee C; Biologics Research Division, Pharmaceutical and Medical Device Research Department, National Institute of Food and Drug Safety Evaluation, Cheongju 28159, Republic of Korea., Heo HR; Biologics Research Division, Pharmaceutical and Medical Device Research Department, National Institute of Food and Drug Safety Evaluation, Cheongju 28159, Republic of Korea., Lee KM; Biologics Research Division, Pharmaceutical and Medical Device Research Department, National Institute of Food and Drug Safety Evaluation, Cheongju 28159, Republic of Korea. |
| Abstrakt: |
Gram-negative bacterial endotoxins can cause pathophysiological effects such as high fever when introduced into the bloodstream. Therefore, endotoxin testing is necessary when producing injectable pharmaceuticals. The pharmaceutical industry has widely used Limulus amebocyte lysate (LAL) to certify product quality. However, ethical concerns have been raised and the increasing scarcity of Limulus polyphemus necessitates the development of novel testing techniques. Recombinant factor C (rFC) was developed using genetic engineering techniques. The aim of this study was to investigate the validity of rFC testing and compare it with the LAL method. The specificity, linearity, accuracy, precision, and robustness of the rFC assay were evaluated. After validation, the rFC assay was found to be suitable for endotoxin detection. We compared the accuracy of the rFC and LAL assays using reference standard endotoxin. The rFC assay was as accurate as the LAL assay. We also compared the two assays using biopharmaceuticals. Greater interference occurred in some samples when the rFC assay was used than when the LAL assay was used. However, the rFC assay overcame the interference when the samples were diluted. Overall, we suggest that rFC can be applied to test biopharmaceuticals. |
