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首页> 外文会议>Conference on single-use technologies II: bridging polymer science to biotechnology applications >DEVELOPING NEW PERFUSION CAPABILITIES FOR AMBR® MICRO AND MINI BIOREACTORS
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DEVELOPING NEW PERFUSION CAPABILITIES FOR AMBR® MICRO AND MINI BIOREACTORS

机译：为AMBR®微型和微型生物反应器开发新的灌注功能

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In recent years a strong trend towards intensified and continuous biopharmaceutical processing has gathered momentum, enabled by key cell culture technologies such as ATF and TFF. However, small-scale application has been limited to traditional benchtop bioreactor formats that are manually intensive, relatively low throughput and costly to operate. Automated high throughput single-use bioreactor systems have transformed fed-batch cell culture bioprocess development over the last decade and new capabilities to support perfusion culture in these micro and mini bioreactor formats could facilitate and accelerate an industry wide transition to intensified and continuous perfusion cell culture processes. Working in close collaboration with biopharm industry development partners, the design of the 'ambr 250 high throughput' bioreactor system has been modified to include hardware, software and single use components required to operate up to 24 parallel bioreactors with ATF or TFF cell retention modes. Iterative prototype testing with development partners has resulted in a novel ambr 250 system design capable of operating for extended culture durations and supporting high cell densities. In addition, a new Generation 2 ambr 15 cell culture system has been developed and demonstrated with technical capabilities facilitating perfusion mimic applications. Case studies will be presented on the utility of new ambr 15 system features for perfusion mimic (20-40M cell/ml) via cell settling and centrifugation methods, together with a range of industry case studies and novel performance data for the new 'ambr 250 perfusion' system (24 parallel perfusion cultures; ＞30d; ＞100M cell/ml; 0.25 vs. 5L; fully automated VCD control). As previously established with ambr systems for fed-batch processes, the new Generation 2 ambr 15 and ambr 250 perfusion systems together have the potential to provide the biopharm industry with a step change in perfusion process development capacity, enabling high throughput bioreactor screening and DoE optimization approaches for accelerated perfusion process development.
机译：近年来，在关键的细胞培养技术（例如ATF和TFF）的推动下，生物技术不断发展的趋势越来越强。然而，小规模的应用已经限于传统的台式生物反应器形式，该形式是人工密集的，相对低的通量并且操作成本高。在过去的十年中，自动化的高通量一次性生物反应器系统已经转变了补料分批细胞培养生物工艺的发展，并且支持这些微型和微型生物反应器形式的灌注培养的新功能可以促进并加速整个行业向强化和连续灌注细胞培养的过渡流程。与生物制药行业发展合作伙伴密切合作，对“ ambr 250高通量”生物反应器系统的设计进行了修改，以包括硬件，软件和一次性组件，这些组件可运行多达24个具有ATF或TFF细胞保留模式的平行生物反应器。通过与开发合作伙伴进行的迭代原型测试，得出了新颖的ambr 250系统设计，该系统能够延长培养时间并支持高细胞密度。另外，已经开发并展示了具有新型技术的第二代ambr 15细胞培养系统，该系统可促进灌注模拟应用。案例研究将通过细胞沉降和离心方法介绍有关ambr 15新系统功能用于灌注模拟（20-40M细胞/ ml）的实用性，以及一系列行业案例研究和新型'ambr 250的新性能数据灌注”系统（24个平行灌注培养;＞ 30d;＞ 100M细胞/ml;0.25对5L;全自动VCD控制）。正如先前使用用于补料分批工艺的ambr系统建立的那样，新一代2代ambr 15和ambr 250灌注系统一起为生物制药行业提供了在灌注工艺开发能力方面逐步改变的潜力，从而实现了高通量生物反应器筛选和DoE优化加快灌注过程开发的方法。

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