AlphaBET - Endotoxin detection for the 21st Century

细菌并不一定要是完整的和“活的”才会引起问题。如果某些细胞成分进入血流，后果可能危及生命。内毒素就是其中的一种成分。内毒素存在于许多细菌的细胞壁中，浓度很高，包括那些驻留在人类胃肠道的细菌。如果内毒素进入我们的血液，它是人类已知的最有效的炎症介质。意外地将内毒素引入血液是有可能的。例如，如果一种可注射药物或其他药物产品，如生理盐水或疫苗，受到内毒素污染，那么给药的行为本身也会带来潜在致命剂量的内毒素。因此，在将所有注射产品投放市场之前，对其进行内毒素检查是至关重要的。目前监管部门批准的内毒素检测方法使用的是从马蹄蟹血液中提取的产品。目前的测试被最终用户认为缓慢、不准确、缺乏敏感性，而且通常不适合现代生产形式。随着对可注射药物的需求的增长，对内毒素检测的更好方法的需求也在增加，包括减少螃蟹衍生试剂的消耗。为了满足这些需求，CMD开发了一种CE标志的仪器Alphabet，它以一种新颖的方式使用监管批准的试剂来提供下一代细菌内毒素检测。Alphabet在速度、精确度、精确度、可靠性和可负担性方面优于所有当前领先的打标方法，重要的是使用了当前使用的测试中使用的试剂的一小部分。拟议中的项目是Alphabet商业化之旅的下一步。IUK的贷款将支持提交英国、欧洲和美国监管机构批准的字母表，建立适当的质量管理标准，完成仪器和消耗品测试墨盒的大规模制造准备，并允许CMD在2022年第一季度预计首次销售之前招聘关键员工。

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.