Risk-based approach to leverage prior knowledge & statistical modeling during process development & process characterization of multivalent vaccines
Vaccine Insights 2023; 2(9), 355–361
The use of prior knowledge, platform processes, and family approaches is increasingly being discussed by drug developers and regulators. The concepts can be applied to product design, process development, process validation, analytical method validation, extractable/leachable testing, stability, and overall control strategies. This article will highlight the benefits of using these approaches, along with appropriate statistical modeling, to develop a risk-based approach for process development and process characterization for vaccines.