Abstract

A COMPREHENSIVE REVIEW ON FORCED DEGRADATION AND ITS REGULATORY FRAMEWORK AS A CRITICAL TOOL IN STABILITY TESTING AND METHOD DEVELOPMENT

Chandrakant M. Ahire*, Ganesh B. Sonawane, Vijayraj N. Sonawane, Rushikesh L. Bacchav, Tejas S. Jadhav, Yash V. Kurhade

Abstract

Forced degradation studies are frequently carried out in the early stages of the development of vaccine candidates in order to learn more about potential degradation routes, promote the development of analytical tools, find suitable stabilizers for vaccines, and determine the ideal storage conditions. Rarely, if ever, are there any procedural instructions on how to conduct forced degradation studies in the regulatory guidelines for forced degradation of biologics. In this article, we present a summary of the approaches utilized to investigate forced deterioration in vaccines, forced degradation instances were undertaken, along with mechanisms of degradation and analysis technique. for vaccination products, and an overview of stabilizers that are employed to affect the outcomes of new candidate vaccines.

Keywords: Forced degradation studies, Degradation routes, Analytical tool, Storage conditions, Regulatory guidelines.