Related Experiment Videos
Conceptual and experimental approaches to address product safety issues raised by novel cell substrates
1Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, MD 20892, USA.
Developments in Biologicals
|January 5, 2002
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.