Adenoviral Vector COVID-19 Vaccines: Process and Cost Analysis
Adenoviral Vector COVID-19 Vaccines: Process and Cost Analysis
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DOI：
10.3390/pr9081430
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发表时间：
2021-08-01
期刊：
影响因子：
3.5
通讯作者：
Petrides, Demetri
中科院分区：
文献类型：
--
作者：
Ferreira, Rafael G.;Gordon, Neal F.;Petrides, Demetri
COVID-19大流行推动了许多疫苗的快速开发，这些疫苗已被证明对SARS-CoV-2有效。这些成功的疫苗中有几种是基于腺病毒载体平台的。这些疫苗的大规模生产构成了巨大的挑战，特别是在大流行的情况下，必须以可负担得起的成本迅速生产大量疫苗。在这项工作中，设计、模拟和经济评估了生产COVID-19腺病毒载体疫苗B1和P1的两个基线工艺，并借助软件SuperPro Designer进行了评估。B1采用批量细胞培养病毒生产步骤，在不锈钢和一次性设备中，病毒滴度为5 × 10（10）个病毒颗粒(VP)/mL。P1采用灌注细胞培养病毒生产步骤，在专用一次性设备中，病毒滴度为1 × 10(12) VP/mL。这两种工艺的规模都达到了每年400立方米疫苗剂量。与B1相比，P1的每剂成本更低（0.15美元对0.23美元），所需的资本投资也少得多（1.26亿美元对2.99亿美元）。媒体和设施相关费用是运营费用的主要来源。结果表明，腺病毒载体疫苗是可以大规模、低成本生产的。
The COVID-19 pandemic has motivated the rapid development of numerous vaccines that have proven effective against SARS-CoV-2. Several of these successful vaccines are based on the adenoviral vector platform. The mass manufacturing of these vaccines poses great challenges, especially in the context of a pandemic where extremely large quantities must be produced quickly at an affordable cost. In this work, two baseline processes for the production of a COVID-19 adenoviral vector vaccine, B1 and P1, were designed, simulated and economically evaluated with the aid of the software SuperPro Designer. B1 used a batch cell culture viral production step, with a viral titer of 5 x 10(10) viral particles (VP)/mL in both stainless-steel and disposable equipment. P1 used a perfusion cell culture viral production step, with a viral titer of 1 x 10(12) VP/mL in exclusively disposable equipment. Both processes were sized to produce 400 M/yr vaccine doses. P1 led to a smaller cost per dose than B1 ($0.15 vs. $0.23) and required a much smaller capital investment ($126 M vs. $299 M). The media and facility-dependent expenses were found to be the main contributors to the operating cost. The results indicate that adenoviral vector vaccines can be practically manufactured at large scale and low cost.