Nan van Geloven

The statistical evaluation and design of virus validation robustness studies


Nan van Geloven, juni 2007

The Sanquin Blood Foundation perorms downscaled experiments of virus reducing process steps to validate the production processes of blood- and plasma-derived products. Robustness studies test the sensitivity of virus reducing process steps to process condition variations.


Data from the studies are based on serial dilution assays. Regression analysis on data from these assays faces several problems: data is scarce, contains a lot of censoring and is subject to measurement error. To overcome these problems, two main efforts have been made in this thesis. Firstly, a validation experiment was set up and analyzed to quantify the factors that cause variation in the data. Secondly, a new regression model is introduced that performs regression on the raw data from the dilution assays directly.