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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: keumurian fj. 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.
Historical evaluation of the in vivo adventitious virus test and its potential for replacement with next generation sequencing (NGS).
Barone PW, Keumurian FJ, Neufeld C, Koenigsberg A, Kiss R, Leung J, Wiebe M, Ait-Belkacem R, Azimpour Tabrizi C, Barbirato C, Beurdeley P, Brussel A, Cassart JP, Cote C, Deneyer N, Dheenadhayalan V, Diaz L, Geiselhoeringer A, Gilleece MM, Goldmann J, Hickman D, Holden A, Keiner B, Kopp M, Kreil TR, Lambert C, Logvinoff C, Michaels B, Modrof J, Mullan B, Mullberg J, Murphy M, O'Donnell S, Peña J, Ruffing M, Ruppach H, Salehi N, Shaid S, Silva L, Snyder R, Spedito-Jovial M, Vandeputte O, Westrek B, Yang B, Yang P, Springs SL. Barone PW, et al. Among authors: keumurian fj. Biologicals. 2023 Feb;81:101661. doi: 10.1016/j.biologicals.2022.11.003. Epub 2023 Jan 6. Biologicals. 2023. PMID: 36621353 Free article.
MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility.
Koenigsberg AL, Fowler V, Domike R, Brussel A, Barone PW, Keumurian FJ, Leung J, Wiebe ME, Brewer MT, Chan S, Dumey N, Fournillier A, Goodnight M, Kindermann J, Leavy R, Lee B, Minning S, Murphy M, Myers E, Nahabedian A, Nanda K, Parriott S, Raju GK, Scallan C, Schoch S, Shiminsky J, Shum B, Teitz S, Westrek B, Springs SL. Koenigsberg AL, et al. Among authors: keumurian fj. PDA J Pharm Sci Technol. 2023 Mar-Apr;77(2):115-132. doi: 10.5731/pdajpst.2021.012691. Epub 2022 Oct 14. PDA J Pharm Sci Technol. 2023. PMID: 36241212
Biopharmaceutical Industry Approaches to Facility Segregation for Viral Safety: An Effort from the Consortium on Adventitious Agent Contamination in Biomanufacturing.
Barone PW, Avgerinos S, Ballard R, Brussel A, Clark P, Dowd C, Gerentes L, Hart I, Keumurian FJ, Kindermann J, Leung JC, Ly N, Mink S, Minning S, Mullberg J, Murphy M, Nöske K, Parriott S, Shum B, Wiebe ME, Springs SL. Barone PW, et al. Among authors: keumurian fj. PDA J Pharm Sci Technol. 2019 Mar-Apr;73(2):191-203. doi: 10.5731/pdajpst.2018.008862. Epub 2018 Oct 25. PDA J Pharm Sci Technol. 2019. PMID: 30361281