Visual identification, analysis and modelling of sterilising grade filtration for liposome enveloped products
脂质体包封产品灭菌级过滤的视觉识别、分析和建模
基本信息
- 批准号:2596197
- 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:2021
- 资助国家:英国
- 起止时间:2021 至 无数据
- 项目状态:未结题
- 来源:
- 关键词:
项目摘要
Bioprocess challenge the project seeks to address:Sterile filtration is essential to the manufacture and safety of biological medicines. The performance of these filtration systems is an industrially relevant challenge that continues to evolve along with next generation therapeutics including viral vectors and liposomes. These products can present difficulties during sterile filtration due to their relatively large size leading to retention within the filter structure. The increasing importance of liposomes has been highlighted by the success of Covid-19 mRNA vaccines which are enveloped and delivered in liposomes. In this project we will combine the high-resolution imaging techniques of confocal microscopy and x-ray computed tomography to measure the means of entrapment for biological components within the filter membrane. Understanding these mechanisms will enable a rational approach to determining operating conditions, membrane type and formulation conditions for sterile filtration of these products.Objectives:- Develop imaging approaches to visualise feed material retention for liposome products, formulations in a range of filter types whilst minimising sample interference- Identify different foulants in complex formulations as they pass or block the filter- Combine information with complementary techniques to determine where and why fouling is occurring to develop predictive models- Apply the knowledge gained to various Pall systems, for example pleated sheet cartridges and TFF systems to demonstrate robustness of the research projectProject Description:Deterioration of performance during sterile filtration of lipid enveloped products e.g. mRNA vaccines is a commonplace issue for industrial scale bioprocesses [1, 2]. At UCL and within the Pall-UCL Centre of Excellence various high-resolution imaging techniques have been successfully used to visualise separation media, including X-ray CT, confocal microscopy, electron microscopy and focused ion beam microscopy. The objective is to characterise the structural features of these materials that determine their bioprocess performance [3-5]. This EngD aims to apply these methods in order to understand Pall sterile filtration separation membrane systems.Each imaging technique has inherent advantages and limitations, we aim to complement relevant approaches to maximise information gathered. For example combining the capabilities of X-ray CT to measure the 3D structure of the membrane with confocal microscopy to identify fluorescently tagged biological components [5] enables the identification of the regions where those components are trapped within a membrane. These can then be correlated with structural features such as an internal pore size decrease or tortuosity increase. The research will combine the information from these various techniques in order to build towards a mechanistic model [6] to predict sterile filtration membrane performance for liposomes.Investigating and comparing multiple sterile grade membranes and liposome types during this project will be used to deepen this mechanistic understanding. We are able to make use of the latest microfluidic liposome synthesis technology (developed by Precision NanoSystems) within the project to further this objective.
该项目寻求解决的生物工艺挑战:无菌过滤对于生物药品的生产和安全至关重要。这些过滤系统的性能是一个与工业相关的挑战,随着包括病毒载体和脂质体在内的下一代疗法的发展而不断发展。这些产品在无菌过滤过程中可能会遇到困难,因为它们的尺寸相对较大,导致滞留在过滤器结构内。 Covid-19 mRNA 疫苗的成功凸显了脂质体日益增长的重要性,该疫苗被脂质体包裹和递送。在这个项目中,我们将结合共焦显微镜和 X 射线计算机断层扫描的高分辨率成像技术来测量过滤膜内生物成分的截留方式。了解这些机制将能够采用合理的方法来确定这些产品无菌过滤的操作条件、膜类型和配方条件。 目标:- 开发成像方法,以可视化脂质体产品、各种过滤器类型中的配方的进料截留,同时最大限度地减少样品干扰 - 识别复杂配方中通过或阻塞过滤器时的不同污垢 - 将信息与补充技术相结合,以确定发生污垢的位置和原因 预测模型 - 将获得的知识应用于各种 Pall 系统,例如褶皱片滤筒和 TFF 系统,以证明研究项目的稳健性项目描述:脂质包封产品(例如液体)在无菌过滤期间性能恶化mRNA 疫苗是工业规模生物过程中的一个常见问题 [1, 2]。在伦敦大学学院和颇尔-伦敦大学学院卓越中心内,各种高分辨率成像技术已成功用于可视化分离介质,包括 X 射线 CT、共焦显微镜、电子显微镜和聚焦离子束显微镜。目的是表征这些材料的结构特征,从而决定其生物工艺性能[3-5]。本工程旨在应用这些方法来了解颇尔无菌过滤分离膜系统。每种成像技术都有固有的优点和局限性,我们的目标是补充相关方法以最大限度地收集信息。例如,将 X 射线 CT 测量膜 3D 结构的功能与共聚焦显微镜的功能相结合,识别荧光标记的生物成分 [5],从而能够识别这些成分被捕获在膜内的区域。然后可以将这些与内部孔径减小或弯曲度增加等结构特征相关联。该研究将结合来自这些不同技术的信息,以建立一个机械模型[6]来预测脂质体的无菌过滤膜性能。在该项目期间研究和比较多种无菌级膜和脂质体类型将用于加深对这种机械的理解。我们能够在该项目中利用最新的微流控脂质体合成技术(由 Precision NanoSystems 开发)来进一步实现这一目标。
项目成果
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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:
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2021 - 期刊:
- 影响因子:0
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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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