Vaccines are biologically complex products, and every stage of their development depends on solid statistical thinking. From Bench to Batch Release brings together the essentials — from natural-history studies and preclinical decision-making through to clinical-trial design, potency assays and modern batch-release strategies — showing how careful use of data strengthens both scientific understanding and regulatory confidence.
The book introduces the core tools needed to design and interpret vaccine studies, with clear, practical explanations supported by real-world example analyses. Key topics include:
-
Understanding disease through natural-history studies
-
Designing efficient, informative preclinical programmes
-
Planning clinical trials for protection, safety and large-scale logistics
-
Correlates of protection and modelling onset of immunity
-
Handling missing data, survival analysis and event-based endpoints
-
Dose–response modelling for vaccine potency assays (4PL, 5PL, parallelism)
-
In vivo vs in vitro potency testing and assay variability
-
Bridging studies to support transitions in batch-release methods
Across all chapters, the emphasis is on clear reasoning, ethical and efficient study design, and practical decision-making. The result is a concise, accessible guide for scientists, statisticians and development teams working to bring safe, effective vaccines to market.
