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首页> 外文会议>Conference on single-use technologies II: bridging polymer science to biotechnology applications >DEVELOPING A FLEXIBLE AUTOMATED CONTINUOUS DOWNSTREAM PROCESSING SYSTEM FOR RESEARCH TO CLINICAL SUPPLY
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DEVELOPING A FLEXIBLE AUTOMATED CONTINUOUS DOWNSTREAM PROCESSING SYSTEM FOR RESEARCH TO CLINICAL SUPPLY

机译：开发灵活的自动化连续下游加工系统以研究临床供应

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Continuous manufacturing has gained a lot of attention over the last 10-15 years for numerous reasons such as the potential for higher efficiencies, reduced cost of goods, and improved product quality. However, the adoption of these technologies has been slow due to concerns over operating these processes in a GMP manufacturing environment. Some of these concerns relate to the operation of multiple continuous unit operations in an integrated process sequence. This presentation will highlight these concerns and show how these issues were addressed by developing an overarching automated and modular platform which can be easily adapted for processing most products. The developed automation platform is the result of a project funded by Innovate UK that brings together a number of biopharmaceutical companies including Allergan, AstraZeneca, Fujifilm Diosynth Biotechnologies and GSK to identify and address these issues. One objective of the project is to develop a flexible automated biologies downstream process consisting of multiple unit operations that can be rapidly reconfigured for manufacturing different products. To that end the process has been design with modularity in mind with each module having common inputs and outputs. The automation software has also been developed in a way that most typical downstream processes can be implemented in the system with little to no software updates. The ability to rapidly reconfigure the process has been demonstrated by using the system to produce two products with different process sequences. Another issue that inhibits the adoption of continuous technologies is the concern over simultaneously operating multiple unit operations. This presentation will detail how the automation software was developed to control both the key unit operations such as chromatography and filtration steps but also intermediate operations such as feed conditioning and viral inactivation steps. The automated system reduces the complexity of downstream processes, which can have in excess of eleven unit operations, to a single user-friendly interface. Implementing this control platform enables a single operator to control the entire process. This presentation will also detail how the automation strategy has been developed to enable a single operator to deal with start-up/shutdown, perturbations in the process and mid-process equipment turnover. It will highlight the challenges that have been faced when developing this system and how these have been overcome. The aim of this project was to improve efficiency by reducing processing time when compared to the current batch process and this was demonstrated by testing the system with two different products (a MAb and a MAb fusion protein). Furthermore, this presentation with show data from the production of these two products that demonstrates comparability between the continuous process and the original batch processes.
机译：在过去的10到15年中，由于许多原因（例如更高的效率潜力，降低的产品成本和改进的产品质量），连续制造赢得了广泛的关注。但是，由于担心在GMP制造环境中操作这些过程，这些技术的采用速度一直很慢。这些问题中的一些涉及集成过程序列中多个连续单元操作的操作。本演讲将重点介绍这些问题，并展示如何通过开发可轻松适用于处理大多数产品的总体自动化和模块化平台来解决这些问题。开发的自动化平台是由Innovate UK资助的一个项目的结果，该项目汇集了包括Allergan，AstraZeneca，Fujifilm Diosynth Biotechnologies和GSK在内的许多生物制药公司，以识别和解决这些问题。该项目的一个目标是开发一种灵活的自动化生物下游流程，该流程由多个单元操作组成，可以快速重新配置以制造不同的产品。为此，在设计过程时要考虑模块化，每个模块都具有共同的输入和输出。自动化软件的开发方式也使得大多数典型的下游过程都可以在系统中实施，而几乎不需要软件更新。通过使用该系统生产具有不同工艺顺序的两种产品，已经证明了快速重新配置工艺的能力。阻碍采用连续技术的另一个问题是对同时运行多个单元操作的关注。本演讲将详细介绍如何开发自动化软件来控制关键单元操作（例如色谱和过滤步骤）以及中间操作（例如进料调节和病毒灭活步骤）。自动化系统将下游流程的复杂性降低到一个用户友好的界面，该流程可以进行十一个以上的单元操作。实施此控制平台可使单个操作员控制整个过程。本演讲还将详细介绍如何制定自动化策略，以使单个操作员能够处理启动/关闭，过程中的扰动和过程中设备周转。它将重点介绍开发该系统时面临的挑战以及如何克服这些挑战。该项目的目的是通过与当前的批处理过程相比减少处理时间来提高效率，并通过使用两种不同的产品（MAb和MAb融合蛋白）测试该系统来证明这一点。此外，此演示文稿还显示了这两种产品的生产数据，证明了连续过程和原始批过程之间的可比性。

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