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- Harry Yang, Ziping Wei, and Mark Schenerman.
- a MedImmune, LLC , Gaithersburg , Maryland , USA.
- J Biopharm Stat. 2015 Jan 1; 25 (2): 234-46.
AbstractWe propose a method for determining the criticality of residual host cell DNA, which is characterized through two attributes, namely the size and amount of residual DNA in biopharmaceutical product. By applying a mechanistic modeling approach to the problem, we establish the linkage between residual DNA and product safety measured in terms of immunogenicity, oncogenicity, and infectivity. Such a link makes it possible to establish acceptable ranges of residual DNA size and amount. Application of the method is illustrated through two real-life examples related to a vaccine manufactured in Madin Darby Canine Kidney cell line and a monoclonal antibody using Chinese hamster ovary (CHO) cell line as host cells.
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