Individual production lots are extensively evaluated. The purified adenoviral DNA is then subjected 
to sequencing. 
A four-stage test program has been designed to assess the master cell bank, the seed lot, the product 
intermediate (cell lysate) and the purified product (virus). The 293 cells used to produce the 
adenovirus will be characterized prior to infection for possible microbial, adventitious viral and 
select specific human viral contaminants. Testing of the adenovirus preparation used to infect the 
cells will include assays for microbial contaminants and adventitious virus. After expansion of the 
infected cells, the cell lysate will be evaluated for microbial contaminants. Product testing of the 
purified product for endotoxin, microbial contaminants, extraneous toxins and infectious adenovirus 
completes the test battery. Each step will be carefully tested for the presence of wild type 
adenovirus. The majority of tests will be performed by Microbiological Associates INC. (MAI), and 
independent laboratory that has provided contract research and safety assessment for the 
pharmaceutical industry. 
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