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An Intra-Company Analysis of Inherent Particles in Biologicals Shapes the Protein Particle Mitigation Strategy Across Development Stages.
Morar-Mitrica S, Pohl T, Theisen D, Boll B, Bechtold-Peters K, Schipflinger R, Beyer B, Zierow S, Kammüller M, Pribil A, Schmelzer B, Boehm S, Goetti M, Serno T. Morar-Mitrica S, et al. Among authors: bechtold peters k. J Pharm Sci. 2023 May;112(5):1476-1484. doi: 10.1016/j.xphs.2023.01.023. Epub 2023 Jan 31. J Pharm Sci. 2023. PMID: 36731778
New FDA draft guidance on immunogenicity.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. 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.
Stabilization of IgG1 in spray-dried powders for inhalation.
Schüle S, Schulz-Fademrecht T, Garidel P, Bechtold-Peters K, Frieb W. Schüle S, et al. Eur J Pharm Biopharm. 2008 Aug;69(3):793-807. doi: 10.1016/j.ejpb.2008.02.010. Epub 2008 Feb 19. Eur J Pharm Biopharm. 2008. PMID: 18477504
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.
35 results