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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: yi l. 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: yi l. 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.
Technical considerations for the implementation of the multi-attribute-method by mass spectrometry in a quality control laboratory.
Pohl T, Gervais A, Dirksen EHC, D'Alessio V, Bechtold-Peters K, Burkitt W, Cao L, Greven S, Lennard A, Li X, Lössner C, Niu B, Reusch D, O'Riordan T, Shearer JW, Spencer D, Xu W, Yi L. Pohl T, et al. Among authors: yi l. Eur J Pharm Biopharm. 2023 Jul;188:231-242. doi: 10.1016/j.ejpb.2023.04.024. Epub 2023 May 3. Eur J Pharm Biopharm. 2023. PMID: 37146738 Free article.
Compliance and regulatory considerations for the implementation of the multi-attribute-method by mass spectrometry in a quality control laboratory.
Gervais A, Dirksen EHC, Pohl T, Bechtold-Peters K, Burkitt W, D'Alessio V, Greven S, Lennard A, Li X, Lössner C, Niu B, Reusch D, O'Riordan T, Shearer JW, Spencer D, Xu W, Yi L. Gervais A, et al. Among authors: yi l. Eur J Pharm Biopharm. 2023 Oct;191:57-67. doi: 10.1016/j.ejpb.2023.08.008. Epub 2023 Aug 13. Eur J Pharm Biopharm. 2023. PMID: 37582411 Free article.
3,332 results