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首页> 外文会议>Conference on single-use technologies II: bridging polymer science to biotechnology applications >HIGH DENSITY PERFUSED BATCH: ROBUSTNESS AND SCALABILITY OF PERFUSION PROCESSES FROM LAB SCALE TO COMMERCIAL SCALE
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HIGH DENSITY PERFUSED BATCH: ROBUSTNESS AND SCALABILITY OF PERFUSION PROCESSES FROM LAB SCALE TO COMMERCIAL SCALE

机译：高密度灌装批次：从实验室规模到商业规模的灌装过程的耐用性和可扩展性

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The advancement on cell retention technologies and downstream processing of the last decades has revived the opportunities for the continuous manufacture of biologics. At Novartis, the vision to make Advanced Integrated Biologics Manufacturing has matured over the past 5 years and it is ready for commercialization. The program is based on novel business strategies, operational approaches and process technologies to reduce time and cost, while increasing flexibility for the different pipeline modalities. As a result, the developed process allows producing commercial quantities in a 10-times smaller manufacturing scale. Over the past 3 years, 3 high-density perfused batch (HDPB) processes have been developed and scaled up showing scaling feasibility and technology robustness. The HDPB concept has enabled a 1000L disposable bioreactor (reaching 3-4 fold higher cell densities with respect to fed batch) to produce the same mass, or greater, as a traditional ～10,000L bioreactor. The flexible nature of the facility enable a fast turn-around and the use of different cell retention devices (e.g. ATF, TFF). Both cell retention devices were evaluated in our HDPB continuous process at lab and manufacturing scale. The filtration technologies (ATF/TFF) were aligned at lab scale using common engineering criteria resulting in a comparable growth, productivity and product quality, while at manufacturing scale different operation strategies were evaluated in order to improve the process robustness. Overall interchangeability between ATF and TFF was demonstrated, though TFF showed significant advantage when comes to operation flexibility and simplicity. The HDPB processes have been developed at lab scale for multiple products, including 1 NBE (new biological entity) and 2 Legacy molecules. Each of the HDPB processes demonstrated consistent process performance and product quality at manufacturing scale and on average delivered 6-10 fold more product, per liter reactor, relative a commercial fed-batch bioreactor. Additionally, a scale-down model (SDM) was successfully qualified, which enabled the start of process characterization for one of the molecules. Novartis efforts to keep growing the technology are strong and include SDM development, screening/optimizing cell retention technologies, as well as, improving the operation of the final scale, among others. The next step in our journey to re-imagine the development and manufacturing of biologies is to bring the program to the commercial stage, which ultimately will help us to reach our patients faster and more cost effectively.
机译：近几十年来，细胞保留技术和下游加工技术的进步为生物制剂的连续生产带来了机遇。在诺华，制造高级集成生物制剂的愿景在过去5年中已经成熟，可以商业化了。该计划基于新颖的业务战略，运营方法和流程技术，以减少时间和成本，同时增加不同管道方式的灵活性。结果，所开发的方法允许以小十倍的制造规模来生产商业数量。在过去的3年中，已经开发并扩大了3种高密度灌注批次（HDPB）工艺，显示出规模可行性和技术稳健性。 HDPB概念使1000L一次性生物反应器（相对于补料批次，细胞密度提高了3-4倍）可以产生与传统10,000L生物反应器相同或更高的质量。该设施的灵活性使之能够快速周转并使用不同的细胞保留装置（例如ATF，TFF）。在我们的HDPB连续过程中，在实验室和制造规模上对这两种细胞保留装置进行了评估。过滤技术（ATF / TFF）使用通用的工程标准在实验室范围内进行校准，以实现可比的增长，生产率和产品质量，而在制造规模上，对不同的操作策略进行了评估，以提高过程的稳定性。演示了ATF和TFF之间的总体互换性，尽管TFF在操作灵活性和简单性方面显示出显着优势。 HDPB工艺已在实验室范围内针对多种产品开发，包括1个NBE（新生物实体）和2个Legacy分子。每个HDPB工艺在制造规模上均表现出一致的工艺性能和产品质量，相对于商用分批补料生物反应器，每升反应器平均可多输送6-10倍的产品。此外，按比例缩小模型（SDM）已成功获得资格，这使得能够开始对一种分子进行工艺表征。诺华一直在努力保持技术的强劲增长，其中包括SDM开发，筛选/优化细胞保留技术，以及改善最终规模的运作等。重新设想生物技术的开发和制造过程中的下一步是将程序带入商业阶段，这最终将帮助我们更快，更经济地接触患者。

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