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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. 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.
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. 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
Analytical methods for process and product characterization of recombinant adeno-associated virus-based gene therapies.
Gimpel AL, Katsikis G, Sha S, Maloney AJ, Hong MS, Nguyen TNT, Wolfrum J, Springs SL, Sinskey AJ, Manalis SR, Barone PW, Braatz RD. Gimpel AL, et al. Among authors: barone pw. Mol Ther Methods Clin Dev. 2021 Feb 17;20:740-754. doi: 10.1016/j.omtm.2021.02.010. eCollection 2021 Mar 12. Mol Ther Methods Clin Dev. 2021. PMID: 33738328 Free PMC article. Review.
Cellular pathways of recombinant adeno-associated virus production for gene therapy.
Sha S, Maloney AJ, Katsikis G, Nguyen TNT, Neufeld C, Wolfrum J, Barone PW, Springs SL, Manalis SR, Sinskey AJ, Braatz RD. Sha S, et al. Among authors: barone pw. Biotechnol Adv. 2021 Jul-Aug;49:107764. doi: 10.1016/j.biotechadv.2021.107764. Epub 2021 May 3. Biotechnol Adv. 2021. PMID: 33957276 Review.
45 results