Virus-Based Vaccine Manufacturing

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Optimize Upstream Productivity and Clarification with Reliable Scale-up

Upstream culture processes developed for manufacturing of virus-based vaccines must be optimized to meet productivity requirements. This optimization includes the clarification step which is essential for removal of cells and cell debris and to ensure a robust virus 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 virus-based vaccine processes. Regulations require that the level of carry-over host cell nucleic acid must be below 10 ng/dose of attenuated virus-based vaccine. Benzonase^® endonuclease treatment followed by tangential flow filtration is a robust and powerful combination to degrade and then remove residual nucleic acid components.

Maximize Downstream Recovery

Benzonase^® endonuclease treatment is sufficient to achieve the desired level of purity for most virus-based vaccines during concentration and diafiltration. Chromatography is required, however, to achieve purity goals for next generation virus-based vaccines such as Japanese encephalitis virus (JEV) and dengue virus (DENV). Because each manufacturing process must be tailored to the characteristics of the virus, a toolbox of options for downstream purification is essential to deliver the desired purity while ensuring an optimal recovery.

Ensure Patient Safety

Even though virus-based vaccines are manufactured using attenuated viruses, ensuring the safety of patients remains an important concern. The final virus vaccine bulk is comparable to that of water. As such, the vaccine can be sterilized using 0.22 µm sterilizing filtration prior to the final formulation and fill finish steps.