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Hepatitis-B surface antigen (HBsAg) powder formulation: process and stability assessment
Yuh-Fun Maa1, Mahmoud Ameri, Cassandra Shu
1PowderJect Vaccines, Inc., 8551 Research Way Boulevard, Middleton, WI 53562, USA. ymaa@alzus.jnj.com
Current Drug Delivery
|February 3, 2007
Summary
Spray freeze-drying (SFD) effectively produced stable hepatitis B surface antigen (HBsAg) dry powder vaccines for epidermal powder immunization (EPI). This method preserved HBsAg potency and immunogenicity, offering a scalable and efficient vaccine formulation.
Area of Science:
- Vaccinology
- Biopharmaceutical Engineering
- Materials Science
Background:
- Hepatitis B virus (HBV) infection remains a significant global health concern.
- Developing stable, easily administered vaccine formulations is crucial for widespread immunization.
- Epidermal powder immunization (EPI) offers a needle-free, potentially more accessible vaccination route.
Purpose of the Study:
- To develop a stable hepatitis B surface antigen (HBsAg) dry powder vaccine formulation for EPI.
- To evaluate various powder-formation methods for their efficiency, scalability, and impact on HBsAg stability.
- To optimize a specific HBsAg dry powder formulation for long-term physical, biochemical, and immunological stability.
Main Methods:
- Prepared HBsAg dry powder formulations using freeze-drying/compress/grind/sieve (FD/C/G/S), spray-drying (SD), agarose beads, and spray freeze-drying (SFD).
- Assessed powder properties (particle size, density, morphology, moisture) and physical stability.
- Determined HBsAg physical, chemical, and biochemical stability using dynamic light scattering and enzyme immune assay.
- Evaluated vaccine immunogenicity in mouse and hairless guinea pig models.
Main Results:
- Spray freeze-drying (SFD) demonstrated superior process efficiency, scalability, and particle characteristics suitable for skin penetration compared to other methods.
- HBsAg retained its potency and immunogenicity after SFD processing, indicating mild stress conditions.
- SFD's rapid freezing mechanism preserved HBsAg nanoparticle size, correlating with enhanced long-term biochemical stability.
- A formulation with 10 µg HBsAg in 1 mg powder, containing trehalose, mannitol, and dextran, showed excellent overall stability.
Conclusions:
- SFD is a viable and efficient method for producing stable HBsAg dry powder vaccine formulations for EPI.
- A systematic formulation strategy successfully optimized an HBsAg dry powder vaccine with excellent long-term stability.
- The developed HBsAg dry powder vaccine demonstrates potential for improved hepatitis B immunization strategies.
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