A fresh look at analytical methods for vaccines
Vaccine Insights 2022; 1(5), 247–258
Recent guidelines have promoted a lifecycle approach to analytical methods. Mimicking a similar paradigm in vaccine product development, this draws attention to a science and risk-based pathway and tools which help ensure successful analytical method development and lifecycle management. However, adoption and implementation of this approach faces serious hurdles, some cultural and others regulatory. This article will describe some key elements and give notification of challenges which must be considered as the vaccines industry and regulators embark on implementing a lifecycle approach to vaccine analytical methods.