{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,14]],"date-time":"2026-03-14T01:06:20Z","timestamp":1773450380953,"version":"3.50.1"},"reference-count":31,"publisher":"BMJ","issue":"12","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["Occup Environ Med"],"accepted":{"date-parts":[[2024,10,21]]},"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:sec>\n<jats:title>Objective<\/jats:title>\n<jats:p>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.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Methods<\/jats:title>\n<jats:p>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.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Results<\/jats:title>\n<jats:p>\nOur 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\u00d710\n<jats:sup>8<\/jats:sup>\nfor the polyester swab (7.8% of the initial quantity), 3.82\u00d710\n<jats:sup>8<\/jats:sup>\nfor a cotton compress (6.4%) and 2.88\u00d710\n<jats:sup>7<\/jats:sup>\nfor a cotton swab (4.8%).\n<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Conclusion<\/jats:title>\n<jats:p>These initial results suggest that viral monitoring of worksurfaces is feasible and will help us to validate the GT product supply chain.<\/jats:p>\n<\/jats:sec>","DOI":"10.1136\/oemed-2024-109574","type":"journal-article","created":{"date-parts":[[2024,12,4]],"date-time":"2024-12-04T18:20:30Z","timestamp":1733336430000},"page":"615-621","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Method for the detection and quantification of viral contamination during the preparation of gene therapy drugs in a hospital pharmacy"],"prefix":"10.1136","volume":"81","author":[{"ORCID":"https:\/\/orcid.org\/0009-0003-4807-9037","authenticated-orcid":false,"given":"Laure","family":"Deramoudt","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marine","family":"Pinturaud","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peggy","family":"Bouquet","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne","family":"Goffard","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5257-440X","authenticated-orcid":false,"given":"Nicolas","family":"Simon","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pascal","family":"Odou","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2024,12,4]]},"reference":[{"key":"2025021207351225000_81.12.615.1","doi-asserted-by":"publisher","DOI":"10.3389\/fmed.2024.1324602"},{"key":"2025021207351225000_81.12.615.2","unstructured":"Directive 2001\/83\/CE of the European parliament and of the council of 6 November 2001 on the community code relating to medicinal products for human use. 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