MilliporeSigma

Virus-Based Vaccine Manufacturing

Process Train for both Inactivated & Live Attenuated Virus

Virus-based vaccines consist of either attenuated or inactivated virus. These vaccines can activate all phases of the immune system and offer rapid and durable long-term immunity by eliciting neutralizing antibodies against the target pathogen.

The process to manufacture attenuated virus-based vaccines is complex, consists of multiple steps and must maintain the infective potential of the attenuated virus. While there is a general workflow for production, a templated approach for manufacturing does not exist. Instead, each process must be tailored based on the shape, size, nature, physico-chemical behavior, stability, and host specificity of the virus.  


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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.


It is a blue line drawing of a microorganism culture or multiple cells scattered in a Petri dish.
This image consists of a filter in the left with gradient density structure and another blue equipment in the right.
The image depicts a simple blue outline of a bottle with a cap. Inside the bottle, there is a molecular structure icon, also in blue. The bottle has straight sides and a square cap, all outlined in blue. The molecular structure consists of circles connected by lines.

We offer the industry’s highest quality sterile filtered liquid capabilities, supplying ready-to-use cell culture media, buffers, CIP and SIP products from GMP facilities worldwide to optimize your biopharma production.

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    Downstream - Tangential Flow Filtration
    The image shows a blue outlined equipment which is user for down streaming chromatorgraphy..
    This image depicts a simplified water filtration system, water flows from the tank through the filter, where impurities are likely removed.
    There are three separate structures made of blue circles connected by lines, resembling molecular models. Each structure consists of multiple circles interconnected in a non-linear fashion, giving an impression of complexity and diversity. The blue color is uniform across all the structures and their connecting lines.
    Final Sterile Filtration & Filling is the last step in the product process and consists of three elements, gas filters, barrier filters, and test tubes.
    A blue outline illustration of a projector connected to a computer monitor displaying a line graph.

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