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Multi-dose Formulation Development for a Quadrivalent Human Papillomavirus Virus-Like Particle-Based Vaccine: Part

Nitya Sharma¹, Kaushal Jerajani¹, Ying Wan¹

¹Department of Pharmaceutical Chemistry, Vaccine Analytics and Formulation Center, University of Kansas, 2030 Becker Drive, Lawrence, KS 66047, USA.

Journal of Pharmaceutical Sciences

|December 3, 2022

Summary

Developing multi-dose Human Papillomavirus (HPV) Virus-Like Particle (VLP) vaccines requires careful antimicrobial preservative (AP) selection. Optimal stability was achieved with specific preservatives, highlighting the need for customized formulation strategies for each HPV VLP vaccine candidate.

Keywords:

Formulations Human papillomavirus Multi-dose Preservatives Stability Vaccine Virus-like particles

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Area of Science:

Vaccine Formulation
Pharmaceutical Development
Immunology

Background:

Multi-dose vaccine formulations require effective antimicrobial preservatives (APs) to ensure product stability and safety.
Human Papillomavirus (HPV) Virus-Like Particle (VLP) vaccines are critical for preventing HPV-related diseases.

Purpose of the Study:

To evaluate the storage stability of candidate multi-dose HPV VLP vaccine formulations with various antimicrobial preservatives (APs).
To identify optimal APs that maintain antigen stability and antimicrobial effectiveness for quadrivalent HPV VLP vaccines.

Main Methods:

Storage stability studies (real-time and accelerated) were conducted on quadrivalent HPV VLP antigens adsorbed to aluminum-salt adjuvant.
Antigen stability (ELISA), antimicrobial effectiveness (European Pharmacopeia assay), protein content (SDS-PAGE), and AP concentration (RP-UHPLC) were measured.
Eight lead candidates were identified based on comprehensive stability assessments.

Main Results:

The aluminum hydroxide-adsorbed HPV18 VLP component was most susceptible to AP-induced destabilization.
Optimal storage stability and antimicrobial effectiveness were achieved with 2-phenoxyethanol, benzyl alcohol, chlorobutanol, or a combination of 2-phenoxyethanol and benzyl alcohol.
Some commonly reported APs (m-cresol, phenol, parabens) showed suboptimal stability in this HPV VLP formulation.

Conclusions:

The selection of antimicrobial preservatives is crucial for the multi-dose formulation of HPV VLP vaccines.
Customized formulation development is necessary for each unique HPV VLP vaccine candidate due to varying sensitivities to preservatives.
This study provides valuable insights for optimizing the stability and efficacy of multi-dose HPV VLP vaccines.