Virus-like particle-based human vaccines: quality assessment based on structural and functional properties

Area of Science:

• Vaccinology and Virology
• Biotechnology and Nanoparticle Engineering

Background:

• Recombinant virus-like particles (VLPs) are utilized as antigens in human vaccines against hepatitis B virus (HBV), human papillomavirus (HPV), and hepatitis E virus (HEV).
• VLPs are self-assembling bionanoparticles (20-60 nm) that mimic native virions, exposing multiple surface epitopes, making them effective prophylactic vaccine candidates.

Purpose of the Study:

• To summarize the development trajectory of VLP-based vaccines from initial research to patient application.
• To describe the physical properties and structural characteristics of VLP vaccines for HBV, HPV, and HEV.
• To review the assessment, control, and optimization of critical quality attributes in VLP-based vaccine bioprocessing.

Main Methods:

• Characterization of physical properties and structural features of recombinant VLP vaccines.
• Analysis of critical quality attributes throughout the bioprocessing of VLP-based vaccines.
• Application of diverse structural and functional analyses to assess and control VLP vaccine quality.

Main Results:

• Successful development and licensure of VLP vaccines for HBV, HPV, and most recently, HEV (Hecolin).
• Detailed description of the structural and physical attributes that contribute to VLP vaccine efficacy.
• Demonstrated methods for assessing and controlling VLP vaccine quality during bioprocessing.

Conclusions:

• VLP technology has yielded successful prophylactic vaccines for three major viral diseases.
• The journey from bench to patient for VLP vaccines highlights the importance of understanding and controlling VLP structural and functional attributes.
• Recent licensure of an HEV VLP vaccine signifies a significant expansion of VLP vaccine applications.