China Creates the World's First Non-Biologically Dependent Endotoxin Detection System
China Creates the World's First Non-Biologically Dependent Endotoxin Detection System
Endotoxin testing in the production of drugs and medical devices has long relied on reagents made from the living blood of the endangered horseshoe crab—which is constrained both by species resources and by foreign technological monopolies, and which also suffers from problems such as lengthy testing time and the inability to monitor in place. This industry pain point was recently solved by a young interdisciplinary team in China.
According to Science and Technology Daily, the Light of the Horseshoe Crab team, led by Wang Qing, a doctoral student at Dalian University of Technology, successfully developed PSO, the world's first non-biologically dependent endotoxin detection system. It has obtained CMA/CNAS authoritative certification and has been applied on the production lines of leading pharmaceutical companies such as Pfizer, marking a shift in China's drug quality control from "biologically constrained" to "independently defined."
Conventional horseshoe-crab reagent testing takes more than an hour and can only be done as offline spot checks; once a production line is contaminated, an entire batch is easily scrapped. At the molecular level, the team pioneered a "blue-blood-like" peptide for precise recognition, completely eliminating the dependency on biological extraction and reaching a detection sensitivity of 10^-12 M. It also created an original acoustic-streaming exciton structure and an optical supersensitive probe, cutting detection response time to 16 seconds—roughly 200 times faster than conventional methods—and enabling real-time, online monitoring throughout the process. This fills the gap of being "unable to perform in-place continuous detection," and can spare a single production line from tens of millions of yuan in contamination losses each year.
Authoritative verification shows that the PSO system achieves a detection limit of 0.0035 EU/mL, better than mainstream international products, with per-test costs reduced by 40% and equipment prices only one-third of imported products.
This achievement effectively breaks the long-standing monopoly of foreign testing reagents, drives the endotoxin testing industry to upgrade from "offline spot checks" to "online full inspection," builds a solid biosafety defense line for domestically developed innovative drugs and devices, and offers a new model for the self-reliance and controllability of biomedical testing equipment.
(Compiled from a report by Science and Technology Daily; the original article, "Chinese Scholars Break the Blue Blood Dependency and Create the World's First Non-Biological Endotoxin Detection System," was published in Science and Technology Daily. Copyright belongs to the original author.)