Viral Vector Vaccine Mfg.

Process train illustrating Viral Vector Vaccines Flow with various icons representing different stages, connected by arrows in a looped pathway.

Process Train for Viral Vector Vaccines

A live vector vaccine uses an attenuated or harmless microorganism such as an adenovirus to transport portions of an antigen to stimulate an immune response. Vectored vaccines are capable of inducing potent cell-mediated immunity, which is essential for complex disease like AIDS, malaria, and cancer among others.

While the manufacturing process for vaccine vectors is fairly templated, some challenges may arise, since several different viruses with varying properties can be used. For large viral vectors, process sterility is critical due to yield loss associated with sterile filtration. There are also challenges with vector aggregation and stability.

In addition, many Phase I/II processes involve adherent cell cultures; as a result, scaling to Phase III and commercial manufacturing can require process adjustments to achieve production targets. In later phases, product yield and purity are critical, as high dosage titers are required in the final product.  Learn more about viral vector vaccine manufacturing.

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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.

The image shows a simple blue icon that represents a microorganism culture in a petri dish on a stand.

Upstream Cell Culture

Nuclease Treatment & Clarification
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The image shows a blue circular symbol containing various shapes and arrows. The shapes include circles, triangles, and rectangles, while the arrows are pointing in different directions.
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.
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.

Final Sterile Filtration & Filling
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