Process development of a SARS-CoV-2 nanoparticle vaccine

Area of Science:

• Biotechnology
• Vaccinology
• Protein Engineering

Background:

• The COVID-19 pandemic necessitated accelerated development of therapeutics and vaccines.
• Traditional biomanufacturing timelines, especially for non-antibody biologics, are lengthy.
• Existing platforms for monoclonal antibody development offer a model for accelerated timelines.

Purpose of the Study:

• To describe the rapid development of a robust process for a two-component self-assembling protein nanoparticle vaccine for SARS-CoV-2.
• To demonstrate an effective academia-industry partnership model for rapid pandemic response.
• To highlight a strategy for improving future pandemic preparedness.

Main Methods:

• Leveraged existing, robust platforms for upstream and downstream processes, analytical methods, and formulation.
• Employed a transient cell line for early material supply.
• Utilized a stable cell pool for toxicology study material manufacturing.

Main Results:

• Successfully developed a robust and reproducible manufacturing process for a SARS-CoV-2 protein nanoparticle vaccine.
• Achieved accelerated development timelines, significantly shorter than traditional methods.
• Demonstrated the efficacy of an academia-industry partnership in rapid response to a global health crisis.

Conclusions:

• The described process enables rapid development of protein nanoparticle vaccines.
• The academia-industry collaboration model is effective for swift pandemic response.
• This approach can enhance future preparedness for emerging infectious disease threats.