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CMC Regulatory Considerations for Antibody-Drug Conjugates.
Bechtold-Peters K, Ruggiero A, Vriezen N, Ihle N, Klein A, Morgan C, Schweizer D, Liu D, Jacobson F, Buecheler J, Panek M, Duggan N, Malyala P, Dupraz P, Desai P, Niu S, Feng Y, Wang X. Bechtold-Peters K, et al. Among authors: dupraz p. J Pharm Sci. 2023 Dec;112(12):2965-2980. doi: 10.1016/j.xphs.2023.09.007. Epub 2023 Sep 21. J Pharm Sci. 2023. PMID: 37741455 Review.
Rapid cGMP manufacturing of COVID-19 monoclonal antibody using stable CHO cell pools.
Agostinetto R, Rossi M, Dawson J, Lim A, Simoneau MH, Boucher C, Valldorf B, Ross-Gillespie A, Jardine JG, Sok D, Burton DR, Hassell T, Broly H, Palinsky W, Dupraz P, Feinberg M, Dey AK. Agostinetto R, et al. Among authors: dupraz p. Biotechnol Bioeng. 2022 Feb;119(2):663-666. doi: 10.1002/bit.27995. Epub 2021 Dec 10. Biotechnol Bioeng. 2022. PMID: 34796474 Free PMC article.
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