AlphaBET - Endotoxin detection for the 21st Century

点击翻译按钮获取中文摘要

Bacteria do not have to be whole and 'alive' to cause problems. If certain cell components enter the blood stream the consequences can be life threatening. Endotoxin is one such component. Found in high-concentrations in the cell wall of many bacteria, including those resident in the human GI tract, endotoxin is the most potent mediator of inflammation known to man if it gets into our bloodstream. It is possible to introduce endotoxin into the blood stream accidentally. For instance, if an injectable medicine, or other pharmaceutical product such as saline or a vaccine, is contaminated with endotoxin, then the very act of administrating the medication will also deliver a potentially lethal dose of endotoxin.It is therefore essential that all injectable products are screened for endotoxin prior to release to the market. The current regulatory approved method for testing for endotoxin uses a product derived from the blood of the horseshoe crab. Current tests are perceived by end-users as slow, imprecise, lacking in sensitivity and generally unsuited to modern forms of production. As demand for injectable medicines grow, so does the need for a better approach to endotoxin testing including the reduced consumption of crab-derived reagent.To address these needs CMD has developed alphaBET, a CE marked instrument that uses regulatory approved reagents in a novel manner to deliver the next generation bacterial endotoxin test. alphaBET outperforms all current marking leading methods in terms of speed, precision, accuracy, reliability and affordability and importantly uses a fraction of the reagent used in currently used tests. The proposed project is the next step in alphaBET's journey to commercialisation. The IUK loan will support submissions for regulatory approval for alphaBET in UK, Europe and US, put appropriate quality management standards in place, complete preparations for large-scale manufacture of the instrument and the consumable test-cartridge and allow CMD to recruit key staff ahead of predicted first sales in Q1 2022.