Virus-like particles (VLP) mimic the overall structure of virus particles but do not contain the infectious genetic material. When used as a vaccine, VLPs cause a robust immunogenic response due to their high-density display of epitopes and the capacity to present multiple proteins to the immune system.
Manufacturing of VLPs involves cell-based expression of the virus-shell protein. VLPs can be expressed in several heterologous expression systems including mammalian cell culture, baculovirus/ insect cell culture system, microbial fermentation and plants. VLPs are either assembled in vivo followed by purification from cell lysate, or the partially assembled protein is recovered from cell lysate and assembled into VLPs in vitro. Learn more about virus-like particle vaccine manufacturing.
The upstream production platform selected for manufacturing of VLPs must be optimized to meet productivity requirements. This optimization includes the clarification step which follows cell lysis for removal of cells and cell debris and ensures a robust harvest of particles. 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 VLP processes. The European Medicines Agency (EMA) and World Health Organization (WHO) allow 10 ng DNA per dose for parenteral vaccines and 100 µg DNA per dose for oral vaccines. Additionally, in order to minimize the risk of host cell nucleic acid oncogenicity, DNA size must be reduced to 100–200 base pairs in length.
VLPs are commonly purified by ultracentrifugation. While this process is well established for small-scale production, it can be time consuming and poorly scalable. Purification methods such as ion-exchange chromatography can be used as an alternative. In certain processes, membrane adsorption and monolith technology can provide better dynamic binding capacity (DBC) than particle-based resins. Multimodal resins that employ both size exclusion and binding-based separation are another option.
To help ensure patient safety, the final VLP product must be sterile filtered using a 0.22 µm filter. Formulation of VLP-based vaccine can be achieved using single-use components; single-use bags containing formulation reagents can be connected to any mixer through sterile quick-connects. After compounding and formulation, the product can be aseptically transferred to single-use filling systems for final filling and vialing.
Maximize upstream productivity of VLPs and ensure robust scalability with:
Achieve the desired yield of VLPs and process efficiency while ensuring robust impurity removal with:
Achieve yield, efficiency and virus recovery goals while ensuring robust impurity removal with:
Ensure patient safety with reliable and robust sterile filtration, formulation and final fill.
A search tool to help you overcome your manufacturing challenges.
A partnership between the biotech companies TechnoVax in the US, our company, and Innovative Biotech in Nigeria aims to empower vaccine development in Africa.
Our company announced that it has signed an agreement with biotechnology company Innovative Biotech (IB) to design the manufacturing process for the first vaccine production facility in Nigeria.
The manufacturing process for VLP-based vaccine is often complex. There are several methods of production. In this handbook, we explain the production of baculovirus-mediated insect cell expressed VLPs.
With the Sf-RVN® Platform, we provide a rhabdovirus-free cell line that improves the safety profile of your vaccine processes combined with a chemically defined medium specifically formulated to get excellent growth and productivity.
Get insights and best practices from a multinational team establishing a platform for vaccine production. See how a long-term collaboration on a bench-scale process used to produce a Virus Like Particle (VLP) vaccine for SARS-CoV-2 was successfully converted to a robust GMP-compatible, scalable process.
Sf-9, a suitable host for production of viral and recombinant products, can carry process contaminating rhabdovirus. This webinar will present first results for growth and expression of a rhabdovirus negative Sf-9 expression platform.
To continue reading please sign in or create an account.
Don't Have An Account?