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Page 1
An Intercompany Perspective on Biopharmaceutical Drug Product Robustness Studies.
Morar-Mitrica S, Adams ML, Crotts G, Wurth C, Ihnat PM, Tabish T, Antochshuk V, DiLuzio W, Dix DB, Fernandez JE, Gupta K, Fleming MS, He B, Kranz JK, Liu D, Narasimhan C, Routhier E, Taylor KD, Truong N, Stokes ESE. Morar-Mitrica S, et al. Among authors: crotts g. J Pharm Sci. 2018 Feb;107(2):529-542. doi: 10.1016/j.xphs.2017.10.017. Epub 2017 Oct 23. J Pharm Sci. 2018. PMID: 29074375
An Intercompany Perspective on Compatibility and In-use Stability Studies to Enable Administration Of Biopharmaceutical Drug Products.
Kamen DE, Crotts G, Narasimhan C, Hu Q, Bhargava AC, Muthurania K, Burton L, Gbormittah FO, Mathews L, Mills B, Hodge T, Saluja S, Singh SN, Tabish T, Wu Y, Stokes ESE. Kamen DE, et al. Among authors: crotts g. J Pharm Sci. 2022 Apr;111(4):1092-1103. doi: 10.1016/j.xphs.2021.09.043. Epub 2021 Sep 30. J Pharm Sci. 2022. PMID: 34600941
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: crotts g. 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: crotts g. 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.