Stability Modelling of mRNA Vaccine Quality Based on Temperature Monitoring throughout the Distribution Chain.
Stability Modelling of mRNA Vaccine Quality Based on Temperature Monitoring throughout the Distribution Chain.
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DOI：
10.3390/pharmaceutics14020430
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发表时间：
2022-02-17
期刊：
影响因子：
5.4
通讯作者：
Kis Z
中科院分区：
文献类型：
--
作者：
Kis Z
一些低收入和中等收入国家的疫苗分销链不足以促进在所需的低温和超低温下快速交付大量热敏性 COVID-19 mRNA 疫苗。目前，COVID-19 mRNA 疫苗与温度监测设备一起分发，以跟踪和识别整个分发链中与预定义条件的偏差。这些温度读数可以输入计算模型，以更准确地量化 mRNA 疫苗关键质量属性 (CQA) 和剩余疫苗保质期。在此，提出了一种动力学建模方法来量化与稳定性相关的 CQA 和 mRNA 疫苗的剩余保质期。 CQA 和保质期值可以根据疫苗从生产设施通过分销网络分发到疫苗接种中心的条件来计算。这种方法有助于量化温度变化对疫苗质量的影响程度，还可以减少疫苗浪费。此外，由于获得了有关 mRNA 疫苗剩余保质期的信息，可以改善疫苗库存管理。这种基于模型的 mRNA 疫苗质量和剩余保质期量化可以改善 COVID-19 mRNA 疫苗在低收入和中等收入国家的部署。
The vaccine distribution chains in several low- and middle-income countries are not adequate to facilitate the rapid delivery of high volumes of thermosensitive COVID-19 mRNA vaccines at the required low and ultra-low temperatures. COVID-19 mRNA vaccines are currently distributed along with temperature monitoring devices to track and identify deviations from predefined conditions throughout the distribution chain. These temperature readings can feed into computational models to quantify mRNA vaccine critical quality attributes (CQAs) and the remaining vaccine shelf life more accurately. Here, a kinetic modelling approach is proposed to quantify the stability-related CQAs and the remaining shelf life of mRNA vaccines. The CQA and shelf-life values can be computed based on the conditions under which the vaccines have been distributed from the manufacturing facilities via the distribution network to the vaccination centres. This approach helps to quantify the degree to which temperature excursions impact vaccine quality and can also reduce vaccine wastage. In addition, vaccine stock management can be improved due to the information obtained on the remaining shelf life of mRNA vaccines. This model-based quantification of mRNA vaccine quality and remaining shelf life can improve the deployment of COVID-19 mRNA vaccines to low- and middle-income countries.
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影响因子：
4.3
作者：
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通讯作者：
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DOI：
10.1108/jhlscm-03-2017-0006
发表时间：
2018-01-01
影响因子：
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作者：
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DOI：
10.1016/j.ejpb.2018.01.005
发表时间：
2018-04-01
影响因子：
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作者：
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