Rapid Metabolite Analyser for Medicines Manufacture
Rapid Metabolite Analyser for Medicines Manufacture
批准号:
104200
负责人:
金额:
$158.91万
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 --
中文摘要
“许多现代药物不再在化学实验室中生产,而是在大型生物反应器中由细胞生产药物(又名生物疗法)。这与酿造啤酒或制作酸奶的过程类似。就像任何活的有机体一样,不同种类的细胞有细微的差别,其中一些在制造高质量药物方面比其他的有效得多。因此,为你要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,定期检查细胞是否健康,是否有适当的营养水平,以确保以尽可能高的产量生产出高质量的药物,这一点很重要。监测这些细胞培养物健康状况的一个极好的参数是一组被称为代谢物的化学物质。这些包括营养物质(维生素、糖、氨基酸、脂肪),也包括代谢副产物(如乳酸)或毒素。目前,虽然生物疗法是有希望的治疗方法,但它们的生产成本很高,因此是一个国家药品预算的巨大消耗。密切和反复监测细胞培养过程中的多种代谢物可以显著提高生产生物治疗药物的效率和成本,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。尽管代谢物监测具有明显的优势,但目前只测量了少数代谢物,并且在该过程中不经常测量。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,机器难以操作并且给出结果的速度很慢。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品中快速测量许多不同的代谢物。重要的是,它将易于使用,更便宜的购买和运行。这将使其可用于药物生产的许多阶段,最终使新药惠及更多患者。”
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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