FAstLyo: Formulation accelerated freeze-drying by reduced vapour flow resistance (micro-collapse)

FAstLyo：通过降低蒸汽流动阻力（微塌陷）加速冷冻干燥的配方

• 批准号: 133425
• 金额: $ 10.05万
• 依托单位: BIOPHARMA PROCESS SYSTEMS LIMITED
• 依托单位国家: 英国
• 项目类别: Feasibility Studies
• 财政年份: 2018
• 资助国家: 英国
• 起止时间: 2018 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=133425
• 关键词: FAstLyo; Formulation; accelerated; freeze; drying

"New medicines/therapies being developed by the pharmaceutical industry and research organizations are increasingly based on some type of biological (rather than chemical) substance, e.g. a large molecule like a protein rather than a small molecule like aspirin. These substances, known collectively as biopharmaceuticals, are significantly more complex to develop and manufacture as a stable and efficacious product than their chemical counter-parts. This increases the demand for new knowledge and understanding to enable the development of these products (for example the composition or formulation of the product) and the associated commercial manufacturing process. Progress in developing new methods and instrumentation which are tailored specifically to the concurrent design of product and process, has been constrained largely by the relatively small market for such instruments and the significant investment that is required to, first test their feasibility, and then develop into a fully validated market offering.The aim of this project is to test the feasibility for developing a new instrument, that has the potential for further development into a high throughput screening tool that will provide the new knowledge required to accelerate and de-risk the development of new product in the fast developing markets for biopharmaceutical, while presenting a unique opportunity for SMEs in the CRO sector and Research Organizations to increase market share and create opportunities for high-skilled employment in this sector."

“制药业和研究机构正在开发的新药/疗法越来越多地基于某种类型的生物（而不是化学）物质，例如蛋白质等大分子，而不是阿司匹林等小分子。这些物质统称为生物药物，作为一种稳定有效的产品，其开发和生产比其化学对应物要复杂得多。这增加了对新知识和理解的需求，以实现这些产品（例如产品的组成或配方）和相关商业生产工艺的开发。在开发专门针对产品和过程的并行设计的新方法和仪器方面的进展，在很大程度上受到了这种仪器相对较小的市场和需要大量投资的限制，首先测试它们的可行性，然后发展成为一个完全有效的市场产品。本项目的目的是测试开发新仪器的可行性，这有可能进一步发展成为一个高通量筛选工具，将提供所需的新知识，以加速和降低风险的新产品的开发在快速发展的市场生物制药，同时提出了一个独特的机会，中小企业在CRO部门和研究组织，以增加市场份额，并创造机会，高技能的就业机会，在这个部门。"