Viral Vector Vaccine Mfg.

Accelerate Time to Clinical While Ensuring Reliable Scale-up

Upstream culture processes developed for manufacturing of viral vector vaccines must be optimized to meet productivity requirements. This optimization includes the cell lysis and clarification steps which are essential for removal of cells and cell debris and to ensure a robust vector harvest. The upstream process is only successful, however, if it can be reliably scaled in order to meet anticipated market demand.

Achieve Yield and Efficiency Goals with Robust Impurity Removal

Nucleic acids from lysed cells are a common contaminant in viral vector vaccine processes. Regulations require that the level of carry-over host cell nucleic acid be below 10 ng/dose of attenuated viral vaccine. Benzonase^® endonuclease treatment followed by tangential flow filtration is a robust and powerful combination to degrade and remove residual nucleic acid components.

Maximize Downstream Recovery

Small-scale clinical lots are typically purified using CsCl-based density gradient ultracentrifugation, while large-scale production requires a two- or three-step chromatography process. Anion exchange is typically used to remove HCP, DNA, RNA, and other major contaminants, while size exclusion chromatography is used for trace contaminant removal.

Ensure Patient Safety

Sterile filtration ensures the sterility of the final formulated product and patient safety. A filter pore size of 0.22 µm or less is required to eliminate microbial contaminants. A key consideration for the sterile filtration process is the level of viral aggregates. These aggregates need to be controlled by optimizing the formulation, otherwise, the sterile filtration process will be challenging with the potential for high losses in yield.