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Expression and Purification of Virus-like Particles for Vaccination
Published on: June 2, 2016
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An integrated and continuous downstream process for microbial virus-like particle vaccine biomanufacture
Lukas Gerstweiler1, Jagan Billakanti2, Jingxiu Bi1
1School of Chemical Engineering and Advanced Materials, The University of Adelaide, Adelaide, South Australia, Australia.
Biotechnology and Bioengineering
|April 28, 2022
Summary
This study introduces a novel continuous downstream process for producing microbial virus-like particle vaccines. The automated method ensures high-quality vaccine production with excellent recovery and productivity.
Area of Science:
- Biotechnology
- Vaccine Development
- Process Engineering
Background:
- Traditional vaccine production often involves complex, multi-step batch processes.
- Developing continuous manufacturing for biologics, like virus-like particles (VLPs), is crucial for efficiency and scalability.
- Current downstream processes for VLPs can be labor-intensive and may face challenges in maintaining consistent product quality.
Purpose of the Study:
- To develop and characterize the first integrated and continuous downstream process for microbial virus-like particle (VLP) vaccine production.
- To demonstrate the robustness and efficiency of the continuous process using a model VLP vaccine (murine polyomavirus VP1 with J8 antigen).
- To evaluate product quality, recovery, and productivity of the continuous VLP manufacturing process.
Main Methods:
- Utilized a modular murine polyomavirus VP1 with integrated J8 antigen as a model VLP vaccine.
- Implemented an integrated continuous downstream process starting from crude cell lysate.
- Employed a flow-through chromatography step followed by periodic counter-current chromatography (PCC) using mixed-mode resin, coupled with in-line assembly.
Main Results:
- The automated continuous process demonstrated robust performance across varying feed concentrations (1.0–3.2 mg/mL) with minimal adjustments.
- Consistently produced high-quality VLPs, free of nucleic acids, with stable purity and an average size of 44.8–47.2 nm.
- Achieved an overall product recovery of 88.6% and a maximum process productivity of 2.56 mg/h/mL resin in the PCC step.
Conclusions:
- The integrated continuous downstream process is a viable and efficient method for VLP vaccine production.
- The combination of flow-through and PCC chromatography enables streamlined, continuous manufacturing of VLPs.
- This approach offers a scalable and robust pathway for producing various VLP-based products.
