title: Conceptual and experimental approaches to address product safety issues raised by novel cell substrates.
abstract: 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.
authors.affiliation: Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, MD 20892, USA.
authors.forename: P R
authors.initials: PR
authors.lastname: Krause
mesh_terms: D002460:Cell Line; D012306:Risk; D017751:Safety Management / Q000379:methods*; D014612:Vaccines
chemical_list: D014612:Vaccines