Method for the detection and quantification of viral contamination during the preparation of gene therapy drugs in a hospital pharmacy.

IF 3.9 2区医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH

Occupational and Environmental Medicine Pub Date : 2024-12-04 DOI:10.1136/oemed-2024-109574

Laure Deramoudt, Marine Pinturaud, Peggy Bouquet, Anne Goffard, Nicolas Simon, Pascal Odou

{"title":"Method for the detection and quantification of viral contamination during the preparation of gene therapy drugs in a hospital pharmacy.","authors":"Laure Deramoudt, Marine Pinturaud, Peggy Bouquet, Anne Goffard, Nicolas Simon, Pascal Odou","doi":"10.1136/oemed-2024-109574","DOIUrl":null,"url":null,"abstract":"Objective: The objective of the present study was to develop a method for sampling and detecting an adenovirus-derived gene therapy (GT) vector on isolator worksurfaces.Methods: We used a quantitative PCR (q-PCR) to detect the viral genome in standard dilutions of pure GT product and extracts of sampled surfaces. We compared three devices for surface sampling (a cotton compress, a cotton swab and a polyester flocked swab) and performed positive control, negative control and induced contamination tests for each.Results: Our results showed that the GT pure product is detected by the q-PCR assay and is amplified throughout the range of dilutions. The mean difference between the expected and measured number of vector particles in the q-PCR assay was 1.27 log. The numbers of particles in the total extracted volume were 4.66×108 for the polyester swab (7.8% of the initial quantity), 3.82×108 for a cotton compress (6.4%) and 2.88×107 for a cotton swab (4.8%).Conclusion: These initial results suggest that viral monitoring of worksurfaces is feasible and will help us to validate the GT product supply chain.","PeriodicalId":19459,"journal":{"name":"Occupational and Environmental Medicine","volume":" ","pages":""},"PeriodicalIF":3.9000,"publicationDate":"2024-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Occupational and Environmental Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1136/oemed-2024-109574","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH","Score":null,"Total":0}

引用次数: 0

Abstract

Objective: The objective of the present study was to develop a method for sampling and detecting an adenovirus-derived gene therapy (GT) vector on isolator worksurfaces.

Methods: We used a quantitative PCR (q-PCR) to detect the viral genome in standard dilutions of pure GT product and extracts of sampled surfaces. We compared three devices for surface sampling (a cotton compress, a cotton swab and a polyester flocked swab) and performed positive control, negative control and induced contamination tests for each.

Results: Our results showed that the GT pure product is detected by the q-PCR assay and is amplified throughout the range of dilutions. The mean difference between the expected and measured number of vector particles in the q-PCR assay was 1.27 log. The numbers of particles in the total extracted volume were 4.66×10⁸ for the polyester swab (7.8% of the initial quantity), 3.82×10⁸ for a cotton compress (6.4%) and 2.88×10⁷ for a cotton swab (4.8%).

Conclusion: These initial results suggest that viral monitoring of worksurfaces is feasible and will help us to validate the GT product supply chain.

查看原文本刊更多论文

医院药房基因治疗药物制备过程中病毒污染的检测与定量方法。

目的：本研究的目的是建立一种在隔离器工作面上取样和检测腺病毒衍生基因治疗（GT）载体的方法。方法：采用定量PCR （q-PCR）方法，在标准稀释的纯GT产品和样品表面提取物中检测病毒基因组。我们比较了三种表面取样设备（棉絮压布、棉签和聚酯棉絮拭子），并对每种设备进行了阳性对照、阴性对照和诱导污染测试。结果：我们的结果表明，GT纯产物可以通过q-PCR检测到，并且在整个稀释范围内扩增。在q-PCR检测中，预期的载体颗粒数与实际的载体颗粒数之间的平均差异为1.27 log。总萃取量中，涤纶棉签的颗粒数为4.66×108（占初始量的7.8%），棉签为3.82×108（占6.4%），棉签为2.88×107（占4.8%）。结论：这些初步结果表明，对工作台面进行病毒监测是可行的，并将帮助我们验证GT产品供应链。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Occupational and Environmental Medicine 医学-公共卫生、环境卫生与职业卫生

CiteScore

8.30

自引率

2.00%

发文量

审稿时长

2 months

期刊介绍： Occupational and Environmental Medicine is an international peer reviewed journal covering current developments in occupational and environmental health worldwide. Occupational and Environmental Medicine publishes high-quality research relating to the full range of chemical, physical, ergonomic, biological and psychosocial hazards in the workplace and to environmental contaminants and their health effects. The journal welcomes research aimed at improving the evidence-based practice of occupational and environmental research; including the development and application of novel biological and statistical techniques in addition to evaluation of interventions in controlling occupational and environmental risks.