Stress Temperature Studies in Small Scale Hastelloy® Drug Substance Containers Lead to Increased Extent of and Increased Variability in Antibody-Drug Conjugate and Monoclonal Antibody Aggregation: Evidence for Novel Oxidation-Induced Crosslinking in Monoclonal Antibodies
Klair, Nathaniel, Kim, Michael T., Lee, Aron, Xiao, Nina J., Patel, Ankit R.
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Published in Journal of pharmaceutical sciences (01.04.2021)
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Leachables from Saline-Containing IV Bags Can Alter Therapeutic Protein Properties
Chang, Judy Y, Xiao, Nina J, Zhu, Min, Zhang, Jennifer, Hoff, Ed, Russell, Stephen J, Katta, Viswanatham, Shire, Steven J
Published in Pharmaceutical research (01.11.2010)
Published in Pharmaceutical research (01.11.2010)
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A Small-scale Model to Assess the Risk of Leachables from Single-use Bioprocess Containers through Protein Quality Characterization
Xiao, Nina J, Medley, Colin D, Shieh, Ian C, Downing, Gregory, Pizarro, Shelly, Liu, Jun, Patel, Ankit R
Published in PDA journal of pharmaceutical science and technology (01.11.2016)
Published in PDA journal of pharmaceutical science and technology (01.11.2016)
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