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.

细菌不必整个，并且“活着”就会引起问题。如果某些细胞成分进入血流，那么后果可能会威胁生命。内毒素就是这样的成分。内毒素在许多细菌的细胞壁中发现，包括居住在人类胃肠道中的细菌，如果它进入我们的血液，则是人类已知的最有效的炎症介质。可以意外地将内毒素引入血液。例如，如果可注射药物或其他药物（例如盐水或疫苗）被内毒素污染，那么给药药物的行为也将提供一种潜在的杀伤性内毒素。当前的监管批准测试内毒素的方法使用了源自马蹄蟹血液的产物。最终用户认为当前的测试是缓慢，不精确，缺乏敏感性，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，需要更好的方法进行内毒素测试的方法，包括减少蟹源试剂的消耗。为了满足这些需求，CMD开发了Alphabet，CMD已开发出一种标记的仪器，该仪器使用了一种新型的方式，以一种新颖的方式以一种新的方式提供下一代一代细菌性内毒素测试。字母在速度，精度，准确性，可靠性和可负担性方面优于所有当前标记领先方法，并且重要的是使用当前使用测试中使用的试剂的一部分。拟议的项目是字母表商业化之旅的下一步。 IUK贷款将支持英国，欧洲和美国字母批准的法规批准的提交，对仪器的大规模制造和可消耗的测试量表制造进行了适当的质量管理标准，并允许CMD在第1季度2022年第1季度的首次销售中招募关键员工。