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Subvisible (2-100 μm) Particle Analysis During Biotherapeutic Drug Product Development: Part 1, Considerations and Strategy.
Narhi LO, Corvari V, Ripple DC, Afonina N, Cecchini I, Defelippis MR, Garidel P, Herre A, Koulov AV, Lubiniecki T, Mahler HC, Mangiagalli P, Nesta D, Perez-Ramirez B, Polozova A, Rossi M, Schmidt R, Simler R, Singh S, Spitznagel TM, Weiskopf A, Wuchner K. Narhi LO, et al. Among authors: wuchner k. J Pharm Sci. 2015 Jun;104(6):1899-1908. doi: 10.1002/jps.24437. Epub 2015 Apr 1. J Pharm Sci. 2015. PMID: 25832583 Review.
A Multicompany Assessment of Submicron Particle Levels by NTA and RMM in a Wide Range of Late-Phase Clinical and Commercial Biotechnology-Derived Protein Products.
Hubert M, Yang DT, Kwok SC, Rios A, Das TK, Patel A, Wuchner K, Antochshuk V, Junge F, Bou-Assaf GM, Cao S, Saggu M, Montrond L, Afonina N, Kolhe P, Loladze V, Narhi L. Hubert M, et al. Among authors: wuchner k. J Pharm Sci. 2020 Jan;109(1):830-844. doi: 10.1016/j.xphs.2019.10.025. Epub 2019 Oct 21. J Pharm Sci. 2020. PMID: 31647951
27 results