Abstract

Some experimental approaches used to assess the contamination risk for plasmid-cloning vectors in Escherichia coli hosts are reviewed, and the problems of interpreting their results are considered. A procedure utilizing mathematical models of the contamination process and the combined results of in vivo and in vitro experiments is suggested as a way of circumventing the limitations of purely empirical risk assessment studies. For illustration of this approach, a specific mathematical model is considered, and a protocol for estimating its parameters is presented. The limitations of this model and the parameter estimation procedure are discussed.

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