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An Intercompany Perspective on Biopharmaceutical Drug Product Robustness Studies.
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
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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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.
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
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