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首页> 外文会议>Conference on single-use technologies II: bridging polymer science to biotechnology applications >PUSHING THE CLOSED AND CONTINUOUS BOUNDARY: END-TO-END ICB AT THE PILOT SCALE
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PUSHING THE CLOSED AND CONTINUOUS BOUNDARY: END-TO-END ICB AT THE PILOT SCALE

机译：寻求封闭和连续的边界：试点规模的端到端ICB

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Encouragingly, the biomanufacturing field continues to move towards GMP implementation of integrated and continuous processes. To our knowledge, all implemented ICB processes - including those at Sanofi - do not extend the ICB boundary to drug substance. In fact, questions remain not just as to whether fully continuous is necessary but whether the required process and engineering technologies yet exist to enable fully continuous at a commercially relevant scale. At Sanofi, we have built on our experience developing and implementing ICB technology to achieve an industry-first demonstration of a fully continuous process, including all typical downstream purification steps, to produce kilograms of drug substance. We will present our vision for end-to-end integrated and continuous biomanufacturing including design goals related to closed processing, automation, and continuous unit operations (not fast batch). Operation at the pilot scale, integrated to an intensified 100L perfusion bioreactor, required creative solutions in many aspects of the run design and execution while allowing for identification of true failure modes and, therefore, identification of areas for future development. Overall, we believe that currently available technology may allow for the realization of an end-to-end closed continuous commercial process. Moreover, our results suggest investment in pushing the continuous boundary may inspire disruptive innovation across bioprocessing to meet long-held aspirations for a truly disruptive facility of the future.
机译：令人鼓舞的是，生物制造领域继续朝着实施GMP的要求，逐步实施一体化和连续性过程。据我们所知，所有已实施的ICB流程-包括赛诺菲的流程-都没有将ICB的范围扩展到原料药。实际上，问题不仅仅在于是否需要完全连续，还在于是否存在所需的工艺和工程技术以实现在商业上相关的规模上完全连续。在赛诺菲，我们积累了开发和实施ICB技术的经验，以实现行业首创的完全连续过程的演示，包括所有典型的下游纯化步骤，可生产千克原料药。我们将展示我们对端到端集成和连续生物制造的愿景，包括与封闭处理，自动化和连续单元操作（非快速批处理）相关的设计目标。在中试规模上运行，并集成到增强型100L灌注生物反应器中，需要在运行设计和执行的许多方面提供创新的解决方案，同时要确定真正的故障模式，从而确定未来的发展领域。总体而言，我们认为当前可用的技术可能允许实现端到端的封闭式连续商业流程。此外，我们的结果表明，为推动连续性发展而进行的投资可能会激发整个生物加工领域的颠覆性创新，以满足人们长期以来对建立真正颠覆性设施的期望。

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