The issue of risk minimization is crucial for producers of biopharmaceutical products – also regarding potential risks of contamination by viruses.
Biopharmaceutical manufacturers are required to use various complementary technologies to protect against virus contamination during production. This is to ensure that a broad spectrum of viruses is inactivated. Large pathogens, such as the HI virus (HIV), can be inactivated using chemical or thermal techniques, for example. It is also possible to remove them using filtration techniques. Inactivation is more difficult with smaller viruses, such as parvoviruses. As single-stranded DNA viruses, these are almost as tiny as therapeutic antibodies. Separation by filtration can, therefore, easily result in product loss, while other established methods such as lowering the pH value, short-term heating, gamma sterilization or irradiation with UV-C light can impair the structure or activity of the product.
A reactor for virus inactivation with UV light was the focus of a research project carried out by ZETA in cooperation with SES-Tec and a partner company from the plasma processing industry. The system was tested at the TechCenter ZETA regarding its applicability in pharmaceutical production processes. Computational fluid dynamics (CFD) analysis and experimental procedures were combined.
The research focal question is: Can UV radiation be used to reliably inactivate viruses in a sensitive blood plasma solution?