Analytical Control Strategy for Biologics. Part I: Foundations
J. Pharm Sci. (2025) 114(7):103826, Kendrick B. S., Sampathkumar K., Gabrielson J. P., Ren D.
Analytical Control Strategy for Biologics. Part II: Roadmap for Development and Implementation
J. Pharm Sci. (2025) 114(8):103834, Sampathkumar K., Kendrick B. S., Gabrielson J.P., Ren D.
Comprehensive multi-attribute method (MAM) workflow for biotherapeutic characterization and cGMP testing
Nat. Protoc. (2023) 8(4):1056-1089, Bones J., Millan-Martin S., Carillo S., Jakes C., Ren D., Rogers R.S.
Attribute analytics performance metrics from the MAM consortium interlaboratory study
J. Am. Soc. Mass Spectrom. (2022) 23(9), 1659-1677. Mouchahoir T. et al.
A high-resolution multi-attribute method for product characterization, process characterization, and quality control of therapeutic proteins
J. Am. Soc. Mass Spectrom. (2022) 15(643), 114575. Guan X., Eris T., Zhang L., Ren D., Ricci M. S., Thiel T., Goudar C. T.
Enabling development, manufacturing, and regulatory approval of biotherapeutics through advances in mass spectrometry
Curr. Opin. Biotechnol. (2022) 71, 206-215. Apostol I., Bondarenko P. V., Ren D., Semin D. J., Wu C. H., Zhang Z., Goudar C. T.
New peak detection performance metrics from the MAM consortium interlaboratory study
J. Am. Soc. Mass Spectrom. (2021) 32(4), 913-928. Mouchahoir T. et al.
Scientific best practices for primary sequence confirmation and sequence variant analysis in the development of therapeutic proteins
J. Pharm. Sci. (2021) 110(2), 619-626. Lund A., Ren D., Rogers R.S., Rouse J.C., Yu X.C., Valliere-Douglass J.F.
Advancing mass spectrometry technology in cGMP environments
Trends Biotechnol. (2020) 38(10), 1051-1053. Ren D.
Gas Phase Ion Chemistry to Determine Isoaspartate in a Peptide Backbone
J. Am. Soc. Mass Spectrom. (2018) 29(7), 1339-1344. Ayrton S.T, Chen X., Bain R.M., Pulliam C.J., Achmatowicz M., Flick T.G., Ren D., Cooks R.G.
Chemical modifications of therapeutic proteins induced by residual ethylene oxide
J. Pharm. Sci. (2015) 104(2), 731-739. Chen L., Sloey C., Zhang Z., Pavel P.V., Kim H., Ren D., Kanapuram S.
Proteomics analysis of altered cellular metabolism induced by insufficient copper level
J. Biotechnol. (2014) 189C, 15-26. Kang S., Xiao G., Ren D., Zhang Z., Le N., Trentalange M., Gupta S., Lin H., Bondarenko P.V.
Discovery and characterization of a photo-oxidative histidine-histidine cross-link in IgG1 antibody utilizing 18O-labeling and mass spectrometry
Anal. Chem. (2014) 86, 4940-4948. Liu M., Zhang Z., Cheetham J., Ren D., Zhou Z.S.
Cell line profiling to improve monoclonal antibody production
Biotechnol. Bioeng. (2014) 111, 748-60. Kang S., Ren D., Xiao G., Daris K., Buck L., Enyenihi A.A., Zubarev R., and Bondarenko P.V., Deshpande R.
Discovery of undefined protein cross-linking chemistry: a comprehensive methodology utilizing 18O-labeling and mass spectrometry
Anal. Chem. (2013) 85, 5900-5908. Liu, M., Zhang, Z., Zang, T., Spahr, C., Cheetham, J., Ren, D., Zhou, Z.S.
