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Page 1
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. 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.
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. 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.
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.
Subvisible (2-100 μm) particle analysis during biotherapeutic drug product development: Part 2, experience with the application of subvisible particle analysis.
Corvari V, Narhi LO, Spitznagel TM, Afonina N, Cao S, Cash P, 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, Weiskopf A, Wuchner K. Corvari V, et al. Among authors: wuchner k. Biologicals. 2015 Nov;43(6):457-73. doi: 10.1016/j.biologicals.2015.07.011. Epub 2015 Aug 29. Biologicals. 2015. PMID: 26324466 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: wuchner k. AAPS PharmSciTech. 2022 Dec 16;24(1):18. doi: 10.1208/s12249-022-02457-9. AAPS PharmSciTech. 2022. PMID: 36526853
A Multicompany Survey Study for Helium Leak Container Closure Integrity Test.
Mathaes R, Wuchner K, Riesop D, Wagner D, Dreher S, Woelfle F, Mudumala PR, Bonvin D, Müller C, Traub-Hoffmann K, Hebting H. Mathaes R, et al. Among authors: wuchner k. PDA J Pharm Sci Technol. 2022 May-Jun;76(3):216-235. doi: 10.5731/pdajpst.2021.012633. Epub 2021 Nov 15. PDA J Pharm Sci Technol. 2022. PMID: 34782444
27 results