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Rapid Metabolite Analyser for Medicines Manufacture

Rapid Metabolite Analyser for Medicines Manufacture
用于药品制造的快速代谢物分析仪
批准号:
104200
负责人:
金额:
$158.91万
依托单位:
依托单位国家:
英国
项目类别:
Collaborative R&D
财政年份:
2018
资助国家:
英国
项目状态:
已结题
起止时间:
2018 至 --

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中文摘要
翻译
“许多现代药物不再是在化学实验室生产,而是在大型生物反应器中生产,细胞在那里生产药物(又称生物疗法)。这类似于酿造啤酒或制作酸奶时发生的事情。就像任何活着的有机体一样,不同类型的细胞有微妙的差异,其中一些在制造高质量药物方面比另一些更有效。因此,为你试图生产的药物选择最好的细胞系是很重要的。此外,在培养细胞时,定期检查它们是否健康并具有适当的营养水平是很重要的,以确保以尽可能高的产量生产高质量的药物。监测这些细胞培养的健康状况的一个极好的参数是一组称为代谢物的不同化学物质。这些包括营养素(维生素、糖、氨基酸、脂肪),但也包括代谢副产物(如乳酸盐)或毒素。目前,尽管生物疗法是有希望的治疗方法,但生物疗法的制造成本很高,因此是一个国家药品预算的巨大消耗。在细胞培养过程中密切和重复监测多种代谢物可以显著提高生物疗法的生产效率和成本,避免代价高昂的培养失败,使更好的药物能够以更低的成本生产,最终使患者受益。尽管代谢物监测有明显的优势,但目前只测量了少数几种,而且在过程中很少出现这种情况。这是因为目前的测量仪器购买非常昂贵,每次测试都很昂贵,机器操作困难,结果出来的速度很慢。我们的解决方案是开发一种突破性的代谢物分析仪,克服上述缺点。我们的分析仪将能够在一个样本中快速测量许多不同的代谢物。重要的是,它将易于使用,购买和运行成本要低得多。这将使其在药品生产的许多阶段都可以使用,最终导致更多的患者获得新药。“
英文摘要
"Many modern medicines are no longer produced in chemistry labs, but instead in big bio-reactors where cells produce the medicines (aka biotherapeutics). This is similar to what happens when beer is brewed or yoghurt is made. Like any living organism, different strains of cells vary subtly with some much more effective at making high quality medicines than others. Thus it is important to select the best cell line for the medicine you are trying to produce. In addition, when growing cells it is important to regularly check that they are healthy and have the right levels of nutrients to ensure that a high quality medicine is produced at highest possible yield.An excellent parameter to monitor the health of these cell cultures is a diverse group of chemicals known as metabolites. These include nutrients (vitamins, sugars, amino acids, fats), but also metabolic by-products (like lactate) or toxins.Currently, whilst they are promising treatments, biotherapeutics are expensive to manufacture, thus are a big drain on a country's medicines budget.The close and repeated monitoring of multiple metabolites in cell culture processes could significantly improve the efficiency and cost of manufacturing biotherapeutics and avoid costly culture failures, enabling better medicines to be produced more cheaply, ultimately benefitting patients.Despite the noted advantages of metabolite monitoring, only a few are measured at present and at infrequent points in the process. This is because current measurement instruments are very expensive to purchase, each test is expensive, the machines are difficult to operate and slow in giving results.Our solution is to develop a breakthrough metabolite analyser that overcomes the above drawbacks. Our analyser will be able to quickly measure many different metabolites in one sample. Importantly it will be easy to use and much cheaper to purchase and run. This will make it usable at many stages of medicines manufacture, ultimately leading to new medicines reaching more patients."
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