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.
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.
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.
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.
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.
Maximize upstream productivity of virus-based vaccines:
Ensure robust scalability:
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.
Achieve yield, efficiency and virus recovery goals while ensuring robust impurity removal.
Remove cross product contamination concerns while streamlining fill-finishing requirements and complying with current regulatory requirements.
A search tool to help you overcome your manufacturing challenges.
In this handbook, we explain the vaccine production processes and process improvements for all types of vaccine development platforms.
Live attenuated viral vaccines can be created using a complex, multi-step cell-based manufacturing process. It is not a templated process. The manufacturing process for each viral vaccine is different.
From process development to full-scale GMP-manufacturing, our global vaccine capabilities can help you achieve these goals for all your modalities/platforms including virus-based, subunit, VLP, viral vector, pDNA and mRNA vaccines.
We collaborated with MEVAC to optimize upstream and downstream processes for FMD vaccine manufacturing to establish a scalable, cost-efficient and GMP compliant process. This white paper focuses on the integration of new filtration strategies in both upstream and downstream processes.
This white paper provides an overview of the challenges presented by current approaches to virus production and the opportunities to develop a platform approach that can work across different viral modalities and accelerate process development.
This application note summarizes the benefits of incorporating Benzonase® endonuclease in a polio virus type 3 production process.
In this article, a comprehensive overview is provided on different filtration technologies and their application in viral vaccine clarification, outlining challenges and present current best practices.
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