AlphaBET - Endotoxin detection for the 21st Century

AlphaBET - 21 世纪的内毒素检测

• 批准号: 830248
• 金额: $ 47.29万
• 依托单位: COTTON MOUTON DIAGNOSTICS LTD
• 依托单位国家: 英国
• 项目类别: Innovation Loans
• 财政年份: 2021
• 资助国家: 英国
• 起止时间: 2021 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=830248
• 关键词: AlphaBET; Endotoxin; detection; 21st; Century

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.

细菌不一定是完整的和“活着的”才能引起问题。如果某些细胞成分进入血液，后果可能危及生命。内毒素就是这样一种成分。在许多细菌的细胞壁中发现高浓度的内毒素，包括那些居住在人类胃肠道中的细菌，如果它进入我们的血液，它是人类已知的最有效的炎症介质。有可能意外地将内毒素引入血流中。例如，如果注射药物或其他药物产品（如生理盐水或疫苗）被内毒素污染，那么给药的行为也会释放潜在的致命剂量的内毒素。因此，所有注射产品在投放市场之前都必须进行内毒素筛查。目前监管部门批准的内毒素检测方法使用的是来自鲎血的产品。目前的测试被最终用户认为是缓慢的，不准确的，缺乏敏感性，一般不适合现代形式的生产。随着对注射药物需求的增长，对更好的内毒素检测方法的需求也在增长，包括减少蟹源性试剂的消耗。为了满足这些需求，CMD开发了alphaBET，这是一种CE认证的仪器，以一种新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、准确度、可靠性和可负担性方面优于目前所有的标记领先方法，重要的是使用了目前使用的测试中使用的一小部分试剂。该项目是alphaBET商业化之旅的下一步。IUK贷款将支持alphaBET在英国，欧洲和美国的监管批准申请，制定适当的质量管理标准，完成仪器和耗材测试盒的大规模制造准备工作，并允许CMD在2022年第一季度预计首次销售之前招募关键员工。