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Viral contamination in biologic manufacture and implications for emerging therapies.
Barone PW, Wiebe ME, Leung JC, Hussein ITM, Keumurian FJ, Bouressa J, Brussel A, Chen D, Chong M, Dehghani H, Gerentes L, Gilbert J, Gold D, Kiss R, Kreil TR, Labatut R, Li Y, Müllberg J, Mallet L, Menzel C, Moody M, Monpoeho S, Murphy M, Plavsic M, Roth NJ, Roush D, Ruffing M, Schicho R, Snyder R, Stark D, Zhang C, Wolfrum J, Sinskey AJ, Springs SL. Barone PW, et al. Among authors: monpoeho s. Nat Biotechnol. 2020 May;38(5):563-572. doi: 10.1038/s41587-020-0507-2. Epub 2020 Apr 27. Nat Biotechnol. 2020. PMID: 32341561 Review.
Report of the 2019 NIST-FDA workshop on standards for next generation sequencing detection of viral adventitious agents in biologics and biomanufacturing.
Cleveland MH, Anekella B, Brewer M, Chin PJ, Couch H, Delwart E, Huggett J, Jackson S, Martin J, Monpoeho S, Morrison T, Ng SHS, Ussery D, Khan AS. Cleveland MH, et al. Among authors: monpoeho s. Biologicals. 2020 Mar;64:76-82. doi: 10.1016/j.biologicals.2020.02.003. Epub 2020 Feb 22. Biologicals. 2020. PMID: 32094072 Free PMC article.
11 results