Validation of a High-Throughput Sequencing Assay for Adventitious Virus Detection
Adventitious agent testing based on high-throughput sequencing (HTS) promises to increase the breadth of viruses that can be detected, filling important gaps in the current testing package. There are, however, several important challenges in validating an HTS assay to the level of quality required by GMP. By modularizing the validation effort, each of these challenges can be met independently. The end result is a flexible assay whose component steps can be refined or replaced without impacting the rest of the pipeline. A final matrix qualification linking the appropriate modules together completes the validation.