Conceptual and experimental approaches to address product safety issues raised by novel cell substrates.
This article provides a brief summary of the defined risks approach to evaluating new cell substrates for vaccine production, and indicates how quantitative data may be applied to assess risks in a regulatory setting. A more detailed discussion of how the potential infectious risk of residual DNA may be evaluated is provided as an example of this process.
Krause
P R
PR
Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, MD 20892, USA.
D002460:Cell Line; D012306:Risk; D017751:Safety Management / Q000379:methods*; D014612:Vaccines
D014612:Vaccines