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SARS-CoV-2 在细胞产品生产过程中传播风险评估研究。

A risk assessment study of SARS-CoV-2 propagation in the manufacturing of cellular products.

机构信息

Minaris Regenerative Medicine GmbH. Haidgraben 5, Ottobrunn, 85521, Germany.

Minaris Regenerative Medicine, LLC. 4 Pearl Ct, Allendale, NJ 07401, USA.

出版信息

Regen Med. 2023 Feb;18(2):169-180. doi: 10.2217/rme-2022-0096. Epub 2022 Dec 1.

DOI:10.2217/rme-2022-0096
PMID:36453030
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9724788/
Abstract

The potential infection of cellular therapies by SARS-CoV-2 present high risks, as the target patients for these treatments are often immunocompromised or have chronic diseases associated with a higher risk of serious illness and death by COVID-19. The multicellular tropism of this virus presents challenges for the manufacturing of cell therapies, whereby the material could potentially become infected at the source or during cell processing. In this review we assess the risk of a SARS-CoV-2 propagation in cell types used to date in cellular therapies. Altogether, the risk of SARS-CoV-2 contamination of cellular products remains low. This risk should be evaluated on an individual basis, considering ACE2 and TMPRSS2 expression, existing literature regarding the susceptibility to infection, and single cell RNA sequencing data of COVID-19 patients. This analysis should ideally be performed for both the cells being manufactured and the cells used to produce the vector to ensure patient safety.

摘要

SARS-CoV-2 对细胞疗法的潜在感染带来了高风险,因为这些治疗的目标患者通常免疫功能低下或患有与 COVID-19 严重疾病和死亡风险较高相关的慢性疾病。该病毒的多细胞趋向性给细胞疗法的制造带来了挑战,在此过程中,原材料在源头或细胞处理过程中可能会受到感染。在这篇综述中,我们评估了迄今为止用于细胞疗法的细胞类型中 SARS-CoV-2 传播的风险。总的来说,SARS-CoV-2 污染细胞产品的风险仍然很低。应根据 ACE2 和 TMPRSS2 的表达、有关易感性的现有文献以及 COVID-19 患者的单细胞 RNA 测序数据,对每个患者进行个体化评估。对于正在制造的细胞和用于产生载体的细胞,都应进行理想的分析,以确保患者安全。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6fc3/9724788/bea56f533263/figure2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6fc3/9724788/cb52940186b1/figure1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6fc3/9724788/bea56f533263/figure2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6fc3/9724788/cb52940186b1/figure1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6fc3/9724788/bea56f533263/figure2.jpg

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