可用于纯化COVID-19疫苗的TOYOPEARL制备填料

    为了应对新型冠状病毒（SARS-CoV-2）引发的世界性大规模病毒感染（COVID-19）（大规模流行病），各个国家/地区都在加速新冠疫苗的研发。虽然现在已经有21种新冠疫苗获得批准，但供应量仍然不够。因此，很多国家/地区选择委托合同生产机构（CMO）进行疫苗生产。新冠疫苗的纯化会使用到各种层析法。下表是已获批上市的新冠疫苗，以及可在其纯化工艺中使用的TOYOPEARL制备层析填料的相关内容。

● 已获批上市的新冠疫苗

* 以上是截至2021年7月26日的数据，并进行了部分修改。包括“特例批准”和“紧急批准”。

Ref.: WHO, Draft landscape of COVID-19 candidate vaccines, https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines

Covid-19 Vaccine Tracker; https://covid19.trackvaccines.org/vaccines/

● 可用于纯化新冠疫苗的TOYOPEARL填料示例

* 根据具体情况，也可使用不同粒径等级的产品（S, M, C, F等级等）。还可使用高速制备TSKgel^® PW系列填料。

在疫苗纯化中，一般会使用尺寸排阻层析（SEC）、离子交换层析（IEC；主要是阴离子交换层析）和疏水层析（HIC），而在Spike蛋白疫苗的纯化中，在纯化末端添加了His-Tag标记的重组蛋白质时，可使用金属螯合亲和层析（IMAC），在纯化mRNA/DNA疫苗时，还可使用羟基磷灰石等多（混合）模式层析（MMC, MXC）填料。

● 用于工艺开发和筛选的预装柱SkillPak^TM

在工艺开发的早期阶段需要进行制备填料的筛选和分离条件探讨/优化，使用容量1 mL或5 mL的预装柱SkillPak，可更加迅速、准确地进行评估。套装产品包含不同模式的各种层析柱，非常有利于层析工艺开发。

（产品网页：https://www.separations.asia.tosohbioscience.com/productjp/process/prosdev）

● 参考文献 （注）参考文献中并未记述疫苗的层析纯化、生产的详细内容。

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