Potency Evaluation and Predictive Quality Control System Construction Strategy for Respiratory Syncytial Virus mRNA Vaccines.

The rapid advancement of respiratory syncytial virus (RSV) mRNA vaccines has created an urgent need for robust, standardized, and predictive potency evaluation systems. Currently, this field relies on diverse, non-standardized in vitro methods that lack quantitative correlations with in vivo immune protection. This poses significant challenges for vaccine process optimization, quality control, and regulatory review. This paper systematically analyzes the strengths and limitations of existing in vitro and in vivo assessment strategies, identifying a bottleneck in the current framework due to the absence of quantitative links between in vitro indicators and in vivo outcomes. It proposes that addressing these challenges hinges on establishing predictive in vitro-in vivo correlation (IVIVC). Furthermore, it outlines a feasible pathway for constructing such predictive models through the design of systematic experimental protocols and multivariate statistical analysis. Alignment with Quality by Design (QbD) principles, this strategy aims to transition potency evaluation from empirical exploration to a predictive, standardized framework, ultimately streamlining the lifecycle management of RSV mRNA vaccines.