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Experimental validation of a parenteral permitted daily exposure value for cleaning-induced degradants from recombinant therapeutic proteins with in vitro immunogenicity assays.
Cohen JR, Joubert MK, Tabassum S, Capili A, Carreon J, Xiang C, Prabhu S, Merlo A, Mytych D, Dolan DG, Kouda R. Cohen JR, et al. Among authors: xiang c. J Pharm Sci. 2024 Oct 28:S0022-3549(24)00490-8. doi: 10.1016/j.xphs.2024.10.041. Online ahead of print. J Pharm Sci. 2024. PMID: 39490658
A High Threshold of Biotherapeutic Aggregate Numbers is Needed to Induce an Immunogenic Response In Vitro, In Vivo, and in the Clinic.
Cohen JR, Brych SR, Prabhu S, Bi V, Elbaradei A, Tokuda JM, Xiang C, Hokom M, Cui X, Ly C, Amos N, Sun J, Calamba D, Herskovitz J, Capili A, Nourbakhsh K, Merlo A, Carreon J, Wypych J, Narhi LO, Jawa V, Joubert MK. Cohen JR, et al. Among authors: xiang c. Pharm Res. 2024 Apr;41(4):651-672. doi: 10.1007/s11095-024-03678-2. Epub 2024 Mar 22. Pharm Res. 2024. PMID: 38519817
1,595 results