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An Intra-Company Analysis of Inherent Particles in Biologicals Shapes the Protein Particle Mitigation Strategy Across Development Stages.
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
An Intercompany Perspective on Biopharmaceutical Drug Product Robustness Studies.
Morar-Mitrica S, Adams ML, Crotts G, Wurth C, Ihnat PM, Tabish T, Antochshuk V, DiLuzio W, Dix DB, Fernandez JE, Gupta K, Fleming MS, He B, Kranz JK, Liu D, Narasimhan C, Routhier E, Taylor KD, Truong N, Stokes ESE.
Morar-Mitrica S, et al.
J Pharm Sci. 2018 Feb;107(2):529-542. doi: 10.1016/j.xphs.2017.10.017. Epub 2017 Oct 23.
J Pharm Sci. 2018.
PMID: 29074375
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Development of a stable low-dose aglycosylated antibody formulation to minimize protein loss during intravenous administration.
Morar-Mitrica S, Puri M, Beumer Sassi A, Fuller J, Hu P, Crotts G, Nesta D.
Morar-Mitrica S, et al.
MAbs. 2015;7(4):792-803. doi: 10.1080/19420862.2015.1046664.
MAbs. 2015.
PMID: 26073995
Free PMC article.
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