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Tumorigenicity assessment of cell therapy products: The need for global consensus and points to consider.
Sato Y, Bando H, Di Piazza M, Gowing G, Herberts C, Jackman S, Leoni G, Libertini S, MacLachlan T, McBlane JW, Pereira Mouriès L, Sharpe M, Shingleton W, Surmacz-Cordle B, Yamamoto K, van der Laan JW. Sato Y, et al. Cytotherapy. 2019 Nov;21(11):1095-1111. doi: 10.1016/j.jcyt.2019.10.001. Epub 2019 Nov 9. Cytotherapy. 2019. PMID: 31711733 Free article. Review.
Inflammation and immunogenicity limit the utility of the rabbit as a nonclinical species for ocular biologic therapeutics.
de Zafra CLZ, Sasseville VG, Matsumoto S, Freichel C, Milton M, MacLachlan TK, Farman C, Raymond I, Gupta S, Newton R, Atzpodien EA, Thackaberry EA. de Zafra CLZ, et al. Among authors: maclachlan tk. Regul Toxicol Pharmacol. 2017 Jun;86:221-230. doi: 10.1016/j.yrtph.2017.03.013. Epub 2017 Mar 16. Regul Toxicol Pharmacol. 2017. PMID: 28322894
Nonclinical Studies that Support Viral Vector-Delivered Gene Therapies: An EFPIA Gene Therapy Working Group Perspective.
Bolt MW, Whiteley LO, Lynch JL, Lauritzen B, Fernández de Henestrosa AR, MacLachlan T, Ulrich P, Philip BK, Mahalingaiah PK, Fuller CL, Compton DR. Bolt MW, et al. Mol Ther Methods Clin Dev. 2020 Sep 1;19:89-98. doi: 10.1016/j.omtm.2020.08.017. eCollection 2020 Dec 11. Mol Ther Methods Clin Dev. 2020. PMID: 33024793 Free PMC article.
Corrigendum to "Inflammation and immunogenicity limit the utility of the rabbit as a nonclinical species for ocular biologic therapeutics" [Regul. Toxicol. Pharmacol. (2017) 221-230].
de Zafra CLZ, Sasseville VG, Matsumoto S, Freichel C, Milton M, MacLachlan TK, Farman C, Raymond I, Gupta S, Newton R, Atzpodien EA, Thackaberry EA. de Zafra CLZ, et al. Among authors: maclachlan tk. Regul Toxicol Pharmacol. 2017 Aug;88:364. doi: 10.1016/j.yrtph.2017.04.006. Epub 2017 Apr 18. Regul Toxicol Pharmacol. 2017. PMID: 28431771 No abstract available.
49 results