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A Tiered Approach for Characterization to Ensure Quality, Reproducibility, and Long-Term Stability of Critical Reagents in Regulated Bioanalysis to Support PK/ADA/NAb Assays for Biologics and Vaccines Programs.
Yang K, Zhang Y, Chou R, Yeung L, Letarte S, Yang RS, Li X, Beaumont M, Gunawan R, Richardson D, Dellatore S, Woolf E, Xu Y. Yang K, et al. Among authors: li x. ACS Pharmacol Transl Sci. 2020 Oct 28;3(6):1310-1317. doi: 10.1021/acsptsci.0c00135. eCollection 2020 Dec 11. ACS Pharmacol Transl Sci. 2020. PMID: 33344904 Free PMC article.
Identification and characterization of a residual host cell protein hexosaminidase B associated with N-glycan degradation during the stability study of a therapeutic recombinant monoclonal antibody product.
Li X, An Y, Liao J, Xiao L, Swanson M, Martinez-Fonts K, Pavon JA, Sherer EC, Jawa V, Wang F, Gao X, Letarte S, Richardson DD. Li X, et al. Biotechnol Prog. 2021 May;37(3):e3128. doi: 10.1002/btpr.3128. Epub 2021 Mar 12. Biotechnol Prog. 2021. PMID: 33476097 Free PMC article.
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