A fresh look at analytical methods for vaccines

ERRATUM In the version of this article initially published, there were several typographical errors. The corrections were made to the HTML and PDF versions of this article as of May 21, 2024.

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. 

Please enter your email to access content Read now