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首页> 外文会议>Conference on single-use technologies II: bridging polymer science to biotechnology applications >INTEGRATED CONTINUOUS BIOPROCESSING: COSTS OF GOODS VERSUS COST OF DEVELOPMENT
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INTEGRATED CONTINUOUS BIOPROCESSING: COSTS OF GOODS VERSUS COST OF DEVELOPMENT

机译：集成式连续生物处理：商品成本与开发成本

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A significant benefit of continuous manufacture is the potential to provide higher productivities compared to traditional batch processes. Smaller facilities with single-use technology could become preferable offering reductions in the capital expenditure. Hence, continuous bioprocessing could offer savings in the cost of goods (COG). However there are other cost factors that need to be considered when evaluating bioprocess facilities in addition to the COG. The cost of development (COD) is a key cost driver that could affect the decision to adopt new manufacturing methods. This study aims to carry out a holistic financial assessment of introducing continuous bioprocessing strategies by considering both the COG and the COD. To be able to perform this level of analysis a decisional tool was developed at University College London to evaluate the cost of implementing traditional batch or continuous bioprocessing (end-to-end and hybrid) at various stages of the drug development pathway. A range of scenarios investigated the economics of different manufacturing strategies at various demands, company sizes and stages of manufacture (pre-clinical, clinical and commercial). Therefore, through the analysis it was possible to determine whether the apparent benefits of continuous bioprocessing translate into cost savings, focusing on the development and commercialisation of monoclonal antibodies.
机译：与传统的批处理方法相比，连续制造的显着优势是可以提供更高的生产率。采用一次性技术的小型设施可能会成为首选，从而减少资本支出。因此，连续的生物加工可以节省商品成本（COG）。但是，在评估生物工艺设施时，除了COG之外，还需要考虑其他成本因素。开发成本（COD）是关键的成本驱动因素，可能会影响采用新制造方法的决策。这项研究旨在通过考虑COG和COD来进行引入连续生物处理策略的整体财务评估。为了能够执行此级别的分析，伦敦大学学院开发了一种决策工具，用于评估在药物开发途径的各个阶段实施传统的批量或连续生物处理（端对端和混合）的成本。一系列方案研究了在各种需求，公司规模和制造阶段（临床前，临床和商业）下不同制造策略的经济性。因此，通过分析，有可能确定连续生物处理的明显好处是否转化为成本节省，重点放在单克隆抗体的开发和商业化上。

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