The safety of biologic medicines relies, in part, on a robust biosafety testing program applied across the biomanufacturing process to evaluate samples for the presence of adventitious agents. For batch mode production processes, biosafety testing takes place along the entire manufacturing process. The main testing points are just after the bioreactor, called bulk harvest lot release testing (BHLRT), as well as at the end of the process before and after fill-finish. The characterization and biosafety testing of raw materials are also required, and in particular, for the manufacturing cell line.
This white paper explores the factors driving the evolution toward faster biosafety testing and describes rapid approaches for adventitious agent testing during cell line characterization and BHLRT that are aligned with current and future manufacturing trends.