Analytical characterization in an era of precision vaccinology

Designing vaccines to be safe and effective is challenging. In addition, global access to an affordable, reliable supply of key vaccines is essential. Vaccines need to work for vast, diverse populations. Safety events may be rare occurrences limited to certain groups. Analytical characterization provides predictors of safety and effectiveness but the links between product characteristics and outcomes during use have often been elusive. Incomplete knowledge of mechanisms, variability in traditional test methods, and indirect correlations between testing models and human immune responses can all obscure the view. Precision vaccinology enables vaccine developers to overcome these challenges, bringing clarity and focus and opening a development pathway bypassing traditional inherently variable assays. Developers have always had to predict safety based on product analytical characteristics. Empirical predictions are severely challenged by the low frequency of rare safety events. Ongoing monitoring of safety events in real-world use sets up the potential for deepening our understanding by employing multivariate analysis tools and artificial intelligence. The value of advanced analytics is in generating hypotheses for testing with precision vaccinology techniques to expand our understanding of mechanisms. Predicting effectiveness in use has its own challenges. New analytical characterization methods may provide greater insight for vaccine development than conventional bioassays, animal studies, and clinical trials. Overcoming quality by inspection mindsets may be difficult but is essential for delivering on all dimensions of quality needed by patients. Implementation of precision vaccinology opens new possibilities for adopting quality by design for vaccines, supporting patient relevant specifications, and expanding access, while ensuring continued safety and efficacy.

Please enter your email to access content Read now