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J Biopharm Stat. 2015;25(2):234-46. doi: 10.1080/10543406.2014.972514.

A statistical approach to determining criticality of residual host cell DNA.

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a MedImmune, LLC , Gaithersburg , Maryland , USA.


We 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.


Critical quality attribute; Infectivity; Oncogenicity; Quality by design; Residual host cell DNA; Risk assessment

[Indexed for MEDLINE]

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