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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. 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. Among authors: richardson dd. Biotechnol Prog. 2021 May;37(3):e3128. doi: 10.1002/btpr.3128. Epub 2021 Mar 12. Biotechnol Prog. 2021. PMID: 33476097 Free PMC article.
New Peak Detection Performance Metrics from the MAM Consortium Interlaboratory Study.
Mouchahoir T, Schiel JE, Rogers R, Heckert A, Place BJ, Ammerman A, Li X, Robinson T, Schmidt B, Chumsae CM, Li X, Manuilov AV, Yan B, Staples GO, Ren D, Veach AJ, Wang D, Yared W, Sosic Z, Wang Y, Zang L, Leone AM, Liu P, Ludwig R, Tao L, Wu W, Cansizoglu A, Hanneman A, Adams GW, Perdivara I, Walker H, Wilson M, Brandenburg A, DeGraan-Weber N, Gotta S, Shambaugh J, Alvarez M, Yu XC, Cao L, Shao C, Mahan A, Nanda H, Nields K, Nightlinger N, Barysz HM, Jahn M, Niu B, Wang J, Leo G, Sepe N, Liu YH, Patel BA, Richardson D, Wang Y, Tizabi D, Borisov OV, Lu Y, Maynard EL, Gruhler A, Haselmann KF, Krogh TN, Sönksen CP, Letarte S, Shen S, Boggio K, Johnson K, Ni W, Patel H, Ripley D, Rouse JC, Zhang Y, Daniels C, Dawdy A, Friese O, Powers TW, Sperry JB, Woods J, Carlson E, Sen KI, Skilton SJ, Busch M, Lund A, Stapels M, Guo X, Heidelberger S, Kaluarachchi H, McCarthy S, Kim J, Zhen J, Zhou Y, Rogstad S, Wang X, Fang J, Chen W, Yu YQ, Hoogerheide JG, Scott R, Yuan H. Mouchahoir T, et al. J Am Soc Mass Spectrom. 2021 Apr 7;32(4):913-928. doi: 10.1021/jasms.0c00415. Epub 2021 Mar 12. J Am Soc Mass Spectrom. 2021. PMID: 33710905 Free article.
49 results