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An Industry Proposal for a Cell and Gene Therapy Safety Data Sheet.
Appl Biosaf. 2023 Sep 1;28(3):176-191. doi: 10.1089/apb.2023.0009. Epub 2023 Sep 12.
Appl Biosaf. 2023.
PMID: 37736420
Environmental Health and Biosafety Risk Assessment Guidance for Commercial-Scale Cell and Gene Therapy Manufacturing.
DiGiandomenico K, Dunn E, Sadowski C, Godwin S, Keeler M, Preston F, Niven P, Ramsey P, Hay H.
DiGiandomenico K, et al.
Appl Biosaf. 2020 Dec 1;25(4):201-213. doi: 10.1177/1535676020946235. Epub 2020 Dec 1.
Appl Biosaf. 2020.
PMID: 36032393
Free PMC article.
Review.
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Environmental Health and Safety Offers a Biosafety Risk Assessment for a Theoretical Model of a Gene Therapy Process Transfer from Research and Development to Large-Scale Manufacturing.
Godwin S, Elkind S, Carey T, DiGiandomenico K, Balbo A, Blocksidge J, Olson J, Miklosko J, Njongmeta L, Preston F, Hodges R.
Godwin S, et al. Among authors: digiandomenico k.
Appl Biosaf. 2023 Sep 1;28(3):164-175. doi: 10.1089/apb.2023.0007. Epub 2023 Sep 12.
Appl Biosaf. 2023.
PMID: 37736419
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