Thomas R. Kreil from Takeda Austria presented at London Calling 2024. The session title was “Pathogen safety in biopharma: sequencing to come.” Kreil began by noting that they do not want to detect viruses in biopharmaceuticals. For this, they use Adventitious Agent Testing (AAT): they search for cytopathic effects on cells. However, current methods are not validated. Furthermore, inactivated vaccine viruses can be detected. Kreil described an example of a porcine virus in a vaccine. It was identified and, luckily, did not infect children. New cell-based technologies cannot use current inactivation approaches, for example. Kreil shared cases in which in vivo testing has been replaced by sequencing. In a second case, Takeda and Oxford Nanopore Technologies (ONT) have collaborated to develop new testing systems. Kreil believes that the long-term goal should be the replacement of existing methods for sequencing-based approaches that protect patients. Kreil also emphasized the importance of updating regulations.
