Recombinant adeno-associated virus (rAAV) is one of the most widely used viral vectors that has been used for gene therapy to treat a variety of human diseases. As a newly developed product type with growing demand, understanding process performance is critical. In this study, flowsheet modeling is used to design a rAAV drug manufacturing process operating in batch and continuous mode. The designed plant has the capability to reach an annual production rate close to 2.7 × 10¹⁹ vg/year. Economic analysis is used to analyze the cost and provide a breakdown into specific categories and unit operations. The Benzonase® nuclease used in the primary clarification contributes the highest amount among the overall costs for both batch and continuous processes. For batch operation, the most cost-effective production rate is 2.6 × 10¹⁹ vg/year which is obtained by applying process debottlenecking method. To understand the process flexibility, different manufacturing scales are compared for batch and continuous operation. The analysis illustrated that the continuous operation becomes advantageous for production above 0.5 × 10¹⁹ vg/year whereas batch operation is more cost-effective to supply AAV products that are less than 0.5 × 10¹⁹ vg/year.

重组腺相关病毒 (rAAV) 是使用最广泛的病毒载体之一，已用于基因治疗以治疗多种人类疾病。作为一种需求不断增长的新开发产品类型，了解工艺性能至关重要。在本研究中，流程图建模用于设计以分批和连续模式运行的 rAAV 药物制造工艺。^{设计的工厂有能力达到接近 2.7 × 10 19}的年生产率vg/年。经济分析用于分析成本并提供具体类别和单位运营的细分。初级澄清中使用的 Benzonase® 核酸酶在分批和连续过程的总成本中贡献最大。对于批量操作，采用工艺去瓶颈法获得的最具成本效益的生产率为 2.6 × 10 ^{19 vg/年。}为了了解工艺的灵活性，我们比较了批量和连续操作的不同制造规模。分析表明，连续操作对于 0.5 × 10 ¹⁹ vg/年以上的生产变得有利，而批量操作对于供应低于 0.5 × 10 ¹⁹ vg/年的 AAV 产品更具成本效益。