Virus-like Particles (VLPs) Vaccine Manufacturing

Process Train for VLP Vaccines

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.

Optimize upstream productivity and clarification with reliable scale-up

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.

Achieve yield and efficiency goals with robust impurity removal

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.

Maximize downstream recovery

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.

Ensure patient safety with sterile filtration, formulation and final fill

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.

Bioprocessing Liquid Cell Culture Media & Buffers

Bioprocessing Liquid Cell Culture Media & Buffers

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

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    Upstream Cell Culture
    Nuclease Treatment & Clarification
    Downstream - Tangential Flow Filtration
    Downstream - Chromatography
    Process Chemicals and Formulation
    Final Sterile Filtration & Filling
    Validation & Testing Services

    Our BioReliance® testing services offer exceptional, risk-mitigating solutions to help you bring life-changing drugs to market, faster.

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