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Improved formulation and lyophilization cycle for rBCG vaccine
Tom H Jin1, Lisa Nguyen, Tianli Qu
1Aeras, 1405 Research Blvd, Suite 300, Rockville, MD 20850, USA. zjin@aeras.org
Vaccine
|May 10, 2011
Summary
A new formulation and freeze-drying process for recombinant BCG vaccine enhances cake appearance and stability. This optimized method ensures high viability and heat resistance for the improved BCG vaccine.
Area of Science:
- Biotechnology
- Vaccine Development
- Pharmaceutical Sciences
Background:
- Conventional BCG vaccine formulations face challenges in cake appearance and integrity.
- Recombinant BCG vaccines require optimized lyophilization processes for stability.
Purpose of the Study:
- To develop an improved formulation and freeze-drying cycle for recombinant BCG vaccine.
- To enhance the cake appearance, integrity, and storage stability of the lyophilized vaccine.
Main Methods:
- Formulation development using mannitol, trehalose, sucrose, and sodium glutamate.
- Freeze-drying cycle optimization including supercooling rates, secondary drying temperatures, and annealing.
- Thermodynamic characterization using differential scanning calorimetry (DSC).
Main Results:
- The optimized formulation and freeze-drying cycle, including an annealing step, promoted mannitol crystallization.
- Failure to crystallize mannitol compromised cake stability, even at elevated secondary drying temperatures.
- The improved process yielded a 53.2% recovery rate and a 61.7% survival rate in accelerated stability studies.
Conclusions:
- Full crystallization of mannitol is essential for the bulking agent in the improved BCG vaccine formulation.
- The developed freeze-dried recombinant BCG vaccine meets BCG vaccine requirements for appearance, viability, and heat stability.
