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Establishing a control system using QbD principles.
Kepert JF, Cromwell M, Engler N, Finkler C, Gellermann G, Gennaro L, Harris R, Iverson R, Kelley B, Krummen L, McKnight N, Motchnik P, Schnaible V, Taticek R. Kepert JF, et al. Among authors: harris r. Biologicals. 2016 Sep;44(5):319-31. doi: 10.1016/j.biologicals.2016.06.003. Epub 2016 Jul 16. Biologicals. 2016. PMID: 27430904 Review.
Non-enzymatic hinge region fragmentation of antibodies in solution.
Cordoba AJ, Shyong BJ, Breen D, Harris RJ. Cordoba AJ, et al. J Chromatogr B Analyt Technol Biomed Life Sci. 2005 Apr 25;818(2):115-21. doi: 10.1016/j.jchromb.2004.12.033. J Chromatogr B Analyt Technol Biomed Life Sci. 2005. PMID: 15734150
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