Stabilizing vaccines via drying: Quality by design considerations.

Area of Science:

• Pharmaceutical Science
• Biotechnology
• Process Engineering

Background:

• Vaccine thermal instability and limited processing capacity hinder global vaccination efforts.
• Pandemics and epidemics pose significant and increasing threats to public health.
• Vaccination remains the most effective strategy for disease prevention.

Purpose of the Study:

• To review challenges in implementing continuous drying techniques for vaccine formulations.
• To investigate conventional and emerging drying technologies, including patented methods.
• To assess the application of Quality by Design (QbD) principles in vaccine drying.

Main Methods:

• Comprehensive literature review of drying technologies and QbD in biopharmaceutical manufacturing.
• Analysis of patented technologies for vaccine drying.
• Evaluation of critical quality attributes (CQAs) and critical process parameters (CPPs) in drying processes.

Main Results:

• Continuous drying presents a promising approach to enhance vaccine stability and scalability.
• Several emerging technologies show potential for industrial adaptation, with ongoing patent activity.
• Successful implementation of QbD is essential for ensuring vaccine quality during continuous drying.

Conclusions:

• Addressing challenges in continuous drying is vital for improving vaccine accessibility and global health security.
• The biopharmaceutical industry needs to adopt QbD principles for robust and scalable vaccine stabilization.
• Further research and development are required to fully realize the potential of continuous drying for vaccines.