Department of Chemical Engineering, University of California, Davis, CA, USA.
Global HealthShare Initiative, University of California, Davis, CA, USA.
Methods Mol Biol. 2022;2480:159-189. doi: 10.1007/978-1-0716-2241-4_11.
Technoeconomic modeling and simulation is a critical step in defining a manufacturing process for evaluation of commercial viability and to focus experimental process research and development efforts. Technoeconomic analysis (TEA) is increasingly demanded alongside scientific innovation by both public and private funding agencies to maximize efficiency of resource allocation. It is particularly important for plant-based manufacturing, and other nontraditional recombinant protein production platforms, to explicitly demonstrate the manufacturing potential and to identify critical technical and economic challenges through robust technoeconomic analysis. In addition, in silico process modeling and TEA of scaled biomanufacturing facilities allows rapid evaluation of the impacts of process and economic changes on capital expenditures (CAPEX, also sometimes referred to as total capital investment), operational expenditures (OPEX, also known as total manufacturing costs or total production costs), cost of goods sold (COGS, also known as unit production costs), and profitability metrics such as net present value (NPV) and discounted cash flow rate of return (DCROR, also known as internal rate of return or IRR). These models can also be used to assess environmental, health, and safety impact of a designed biomanufacturing facility to evaluate its sustainability and environmental-friendliness. Here we describe a general method for performing technoeconomic modeling and simulation for and environmental assessment of plant-based manufacturing of recombinant proteins.
技术经济建模与模拟是定义制造工艺以评估商业可行性并集中进行实验性工艺研究与开发工作的关键步骤。技术经济分析（TEA）越来越受到公共和私人资助机构的要求，以提高资源配置效率，与科学创新齐头并进。对于基于植物的制造以及其他非传统重组蛋白生产平台，通过强大的技术经济分析明确展示制造潜力并确定关键技术和经济挑战尤为重要。此外，通过对规模化生物制造设施进行计算机模拟过程建模和技术经济分析，可以快速评估工艺和经济变化对资本支出（CAPEX，有时也称为总资本投资）、运营支出（OPEX，也称为总制造成本或总生产成本）、销售成本（COGS，也称为单位生产成本）和盈利能力指标（如净现值（NPV）和折现现金流量回报率（DCROR，也称为内部收益率或 IRR）的影响。这些模型还可用于评估设计中的生物制造设施的环境、健康和安全影响，以评估其可持续性和环境友好性。在这里，我们描述了一种用于进行基于植物的重组蛋白制造的技术经济建模与模拟以及环境评估的通用方法。
