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Enzymatic degradation pattern of polysorbate 20 impacts interfacial properties of monoclonal antibody formulations.
Eur J Pharm Biopharm. 2024 Jan;194:74-84. doi: 10.1016/j.ejpb.2023.11.024. Epub 2023 Nov 30.
Eur J Pharm Biopharm. 2024.
PMID: 38042510
Free article.
Screening techniques for monitoring the sub-visible particle formation of free fatty acids in biopharmaceuticals.
Chen W, Klemm D, Gregoritza K, Satya Krishna Kishore R, Olaf Stracke J, Wurth C, Pinto C, Sancho Oltra N.
Chen W, et al. Among authors: gregoritza k.
Eur J Pharm Biopharm. 2023 Sep;190:242-247. doi: 10.1016/j.ejpb.2023.07.018. Epub 2023 Jul 29.
Eur J Pharm Biopharm. 2023.
PMID: 37524212
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Metal-Induced Fatty Acid Particle Formation Resulting from Hydrolytic Polysorbate Degradation.
Gregoritza K, Cai SK, Siketanc M, Woehr A, Lebouc V, Kishore RSK, Nicoulin V, Bleher S, Allmendinger A.
Gregoritza K, et al.
J Pharm Sci. 2022 Mar;111(3):743-751. doi: 10.1016/j.xphs.2021.09.044. Epub 2021 Oct 1.
J Pharm Sci. 2022.
PMID: 34600939
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Evaluating a Modified High Purity Polysorbate 20 Designed to Reduce the Risk of Free Fatty Acid Particle Formation.
Doshi N, Ritchie K, Shobha T, Giddings J, Gregoritza K, Taing R, Rumbelow S, Chu J, Tomlinson A, Kannan A, Saggu M, Cai SK, Nicoulin V, Liu W, Russell S, Luis L, Yadav S.
Doshi N, et al. Among authors: gregoritza k.
Pharm Res. 2021 Sep;38(9):1563-1583. doi: 10.1007/s11095-021-03087-9. Epub 2021 Sep 8.
Pharm Res. 2021.
PMID: 34495486
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