Digital Design for Crystallisation in Advanced Pharmaceutical Manufacturing: Uncertainty of information and how to find data
先进药品制造中结晶的数字化设计:信息的不确定性以及如何查找数据
基本信息
- 批准号:2890547
- 负责人:
- 金额:--
- 依托单位:
- 依托单位国家:英国
- 项目类别:Studentship
- 财政年份:2022
- 资助国家:英国
- 起止时间:2022 至 无数据
- 项目状态:未结题
- 来源:
- 关键词:
项目摘要
Advanced pharmaceutical manufacturing approaches including continuous pharmaceutical manufacturing (C-PM) involve complex operations requiring high degrees of process control, understanding and experience. We are innovating the development of smart, AI-driven and robotically enabled development platforms, or 'DataFactories' to accelerate product and process development and enable the development and application of digital twins. CMAC's vision is to deliver the digital transformation of Chemistry, Manufacturing and Control (CMC) operations as part of the approval of new medicines and a key aim of this is the development of a Crystallisation Classification System (CCS) that will allow rapid prediction of crystallisation outcomes from targeted, material sparing experimental approaches. Significant investment by CMAC has established new DataFactories for accelerated crystallisation development using model driven experimental design and collaborative robotics to drive initial experiments to estimate thermodynamic (solubility) and kinetic (nucleation, growth) parameters as well as key particle attributes (solid form, size and shape) that will direct process design. The platform's comprise multiple sensors with offline measurements and data analysis to achieve this. Currently, the measurement of uncertainties and their propagation throughout the digital design process are not well understood. Evaluation of these at all measurement points in the CCS DataFactory will improve process understanding, identify routes for improvement and build confidence in digital tools. Presently, there are no common standards for the storage of (meta)data of instruments or the handling of such large heterogenous data. While control software tools attempt to capture the information required to regulate the processes ad-hoc, they do not facilitate capturing analytical results from process-related instruments. Thus, there is a need for improved data storage, governance and access to the myriad of information about complex mulit-phase processes to enhance the quality and efficiency of medicines development and manufacturing and realise the full potential of digital transformation. The PhD will focus on the acquisition of comprehensive data using the DataFactory and develop novel methods for the propagation of information and uncertainty delivered through the novel Crystallisation Parameter database being established as part of CMAC's vision to become the data centre for pharmaceutical products and processes and deliver the CCS.
包括连续制药(C-PM)在内的先进制药方法涉及复杂的操作,需要高度的过程控制、理解和经验。我们正在创新开发智能、人工智能驱动和机器人驱动的开发平台,即“数据工厂”,以加速产品和工艺开发,并实现数字孪生的开发和应用。CMAC的愿景是将化学、制造和控制(CMC)操作的数字化转型作为新药审批的一部分,其中一个关键目标是开发结晶分类系统(CCS),该系统将允许通过有针对性的、节省材料的实验方法快速预测结晶结果。CMAC的重大投资建立了新的数据工厂,用于加速结晶开发,使用模型驱动实验设计和协作机器人来驱动初始实验,以估计热力学(溶解度)和动力学(成核,生长)参数以及关键颗粒属性(固体形式,尺寸和形状),这些将指导工艺设计。该平台由多个传感器组成,具有离线测量和数据分析功能。目前,不确定度的测量及其在数字化设计过程中的传播还没有得到很好的理解。在CCS数据工厂的所有测量点对这些进行评估,将提高对过程的理解,确定改进的路线,并建立对数字工具的信心。目前,对于仪器(元)数据的存储或此类大型异构数据的处理,还没有统一的标准。虽然控制软件工具试图捕获临时调节过程所需的信息,但它们不能方便地从过程相关仪器中捕获分析结果。因此,需要改进数据存储、治理和获取有关复杂多阶段过程的大量信息,以提高药物开发和制造的质量和效率,并充分发挥数字化转型的潜力。博士学位将专注于使用数据工厂获取综合数据,并开发通过新型结晶参数数据库传播信息和不确定性的新方法,该数据库是CMAC愿景的一部分,旨在成为制药产品和工艺的数据中心,并提供CCS。
项目成果
期刊论文数量(0)
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其他文献
吉治仁志 他: "トランスジェニックマウスによるTIMP-1の線維化促進機序"最新医学. 55. 1781-1787 (2000)
Hitoshi Yoshiji 等:“转基因小鼠中 TIMP-1 的促纤维化机制”现代医学 55. 1781-1787 (2000)。
- DOI:
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LiDAR Implementations for Autonomous Vehicle Applications
- DOI:
- 发表时间:
2021 - 期刊:
- 影响因子:0
- 作者:
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吉治仁志 他: "イラスト医学&サイエンスシリーズ血管の分子医学"羊土社(渋谷正史編). 125 (2000)
Hitoshi Yoshiji 等人:“血管医学与科学系列分子医学图解”Yodosha(涉谷正志编辑)125(2000)。
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Effect of manidipine hydrochloride,a calcium antagonist,on isoproterenol-induced left ventricular hypertrophy: "Yoshiyama,M.,Takeuchi,K.,Kim,S.,Hanatani,A.,Omura,T.,Toda,I.,Akioka,K.,Teragaki,M.,Iwao,H.and Yoshikawa,J." Jpn Circ J. 62(1). 47-52 (1998)
钙拮抗剂盐酸马尼地平对异丙肾上腺素引起的左心室肥厚的影响:“Yoshiyama,M.,Takeuchi,K.,Kim,S.,Hanatani,A.,Omura,T.,Toda,I.,Akioka,
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