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Page 1
CMC Regulatory Considerations for Antibody-Drug Conjugates.
Bechtold-Peters K, Ruggiero A, Vriezen N, Ihle N, Klein A, Morgan C, Schweizer D, Liu D, Jacobson F, Buecheler J, Panek M, Duggan N, Malyala P, Dupraz P, Desai P, Niu S, Feng Y, Wang X. Bechtold-Peters K, et al. J Pharm Sci. 2023 Dec;112(12):2965-2980. doi: 10.1016/j.xphs.2023.09.007. Epub 2023 Sep 21. J Pharm Sci. 2023. PMID: 37741455 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: bechtold peters k. 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. Among authors: bechtold peters k. 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.
Classification of protein aggregates.
Narhi LO, Schmit J, Bechtold-Peters K, Sharma D. Narhi LO, et al. Among authors: bechtold peters k. J Pharm Sci. 2012 Feb;101(2):493-8. doi: 10.1002/jps.22790. Epub 2011 Oct 11. J Pharm Sci. 2012. PMID: 21989781
Not the Usual Suspects: Alternative Surfactants for Biopharmaceuticals.
Brosig S, Cucuzza S, Serno T, Bechtold-Peters K, Buecheler J, Zivec M, Germershaus O, Gallou F. Brosig S, et al. Among authors: bechtold peters k. ACS Appl Mater Interfaces. 2023 Jul 26;15(29):34540-34553. doi: 10.1021/acsami.3c05610. Epub 2023 Jul 14. ACS Appl Mater Interfaces. 2023. PMID: 37450418
New FDA draft guidance on immunogenicity.
Parenky A, Myler H, Amaravadi L, Bechtold-Peters K, Rosenberg A, Kirshner S, Quarmby V. Parenky A, et al. Among authors: bechtold peters k. AAPS J. 2014 May;16(3):499-503. doi: 10.1208/s12248-014-9587-6. Epub 2014 Mar 29. AAPS J. 2014. PMID: 24682766 Free PMC article.
35 results