Study-specific procedures , good laboratory

These assays, which have been standardized and validated at InterceU AG s Ghni-cal Immunology Laboratory, enable reliable measurements of epitope-specific T cell responses induced by vaccination. All assays were performed in compliance with Good Laboratory Practice (GLP)/Good Clinical Practice (GCP) requirements. Standardization of the blood cell isolation procedure at the different investigational sites led to a high rate of evaluable assays. However, due to the lack of inter-laboratory standardization of T cell assays, comparison of the results of this study with published data from similar trials is difficult. Cryopre-served blood cells were used, which may have resulted in a possible underestimation of T cell responses compared with assays that utilize fresh blood. 

An important aspect is that of data and model stability. The raw data, for example, assay data, need to be updated regularly as new results become available. This process is tedious and time consuming and once a valid protocol for data acquisition and validation has been established, it is suitable for automation. The automatic procedure requires extensive data integrity checks (e.g., do all data points have valid structures and experimental results, how to handle conflicting results from different experiments) and a formalized automated normahzation process. This involves answering questions such as how to handle isomers, do experimental in vivo results have precedence over in vitro results or should all results be shown, should more confidence be put in results from Good Laboratory Practice (GLP)-studies, and so on. The models are then automatically rebuilt using the updated data and auto-updated as was mentioned in the QSAR section. A model may be promoted to use in the production system if it passes some defined validation tests, specific for each model, which was also mentioned earlier. 

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