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- W3027720986 abstract "Background & Aim Per regulatory requirements, cell-culture based therapies must be free of mycoplasma. Manufacturers have traditionally outsourced testing to labs that specialize in the 28-day culture-based test method. For manufacturers of gene and cell therapy products, as well as other low-dose and short shelf-life therapeutics, it is not feasible to wait 28 days for test results. Thus, the need for rapid mycoplasma test results has also increased. Real-time PCR based assays provide a viable alternative to the culture based method and provide results in hours while meeting the required sensitivity. Following validation, regulatory filing and review, users across multiple therapeutic modalities have received regulatory acceptance for use of a rapid, real-time PCR based mycoplasma detection assay. Methods, Results & Conclusion See above for abstract - No separare abstract for methods, results & conclusion" @default.
- W3027720986 created "2020-05-29" @default.
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- W3027720986 date "2020-05-01" @default.
- W3027720986 modified "2023-09-26" @default.
- W3027720986 title "A Rapid Alternative to Culture Based Mycoplasma Detection" @default.
- W3027720986 doi "https://doi.org/10.1016/j.jcyt.2020.03.343" @default.
- W3027720986 hasPublicationYear "2020" @default.
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