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Industry Perspective on the use and Characterization of Polysorbates for Biopharmaceutical Products Part 1: Survey Report on Current State and Common Practices for Handling and Control of Polysorbates.
Wuchner K, Yi L, Chery C, Nikels F, Junge F, Crotts G, Rinaldi G, Starkey JA, Bechtold-Peters K, Shuman M, Leiss M, Jahn M, Garidel P, de Ruiter R, Richer SM, Cao S, Peuker S, Huille S, Wang T, Le Brun V. Wuchner K, et al. Among authors: nikels f. J Pharm Sci. 2022 May;111(5):1280-1291. doi: 10.1016/j.xphs.2022.02.009. Epub 2022 Feb 22. J Pharm Sci. 2022. PMID: 35192858 Review.
Industry Perspective on the Use and Characterization of Polysorbates for Biopharmaceutical Products Part 2: Survey Report on Control Strategy Preparing for the Future.
Wuchner K, Yi L, Chery C, Nikels F, Junge F, Crotts G, Rinaldi G, Starkey JA, Bechtold-Peters K, Shuman M, Leiss M, Jahn M, Garidel P, de Ruiter R, Richer SM, Cao S, Peuker S, Huille S, Wang T, Brun VL. Wuchner K, et al. Among authors: nikels f. J Pharm Sci. 2022 Nov;111(11):2955-2967. doi: 10.1016/j.xphs.2022.08.021. Epub 2022 Aug 21. J Pharm Sci. 2022. PMID: 36002077 Review.
An Interlaboratory Study to Identify Potential Visible Protein-Like Particle Standards.
Telikepalli SN, Carrier MJ, Ripple DC, Barnett G, Bhirde A, Bolton D, Bou-Assaf GM, Ferrari E, Leigh S, Levitskaya-Seaman S, Menzen T, Nikels F, Riley A, Saggu M, Sahni N, Vernooij E, Wuchner K. Telikepalli SN, et al. Among authors: nikels f. AAPS PharmSciTech. 2022 Dec 16;24(1):18. doi: 10.1208/s12249-022-02457-9. AAPS PharmSciTech. 2022. PMID: 36526853
Monitoring of Visible Particles in Parenteral Products by Manual Visual Inspection-Reassessing Size Threshold and Other Particle Characteristics that Define Particle Visibility.
Mazaheri M, Saggu M, Wuchner K, Koulov AV, Nikels F, Chalus P, Das TK, Cash PW, Finkler C, Levitskaya-Seaman SV, Case J, Parsons J, Gonzalez K. Mazaheri M, et al. Among authors: nikels f. J Pharm Sci. 2024 Mar;113(3):616-624. doi: 10.1016/j.xphs.2023.10.002. Epub 2023 Oct 5. J Pharm Sci. 2024. PMID: 37802369
12 results