Forced degradation studies: an essential tool for the formulation development of vaccines

Forced degradation studies are typically conducted during the early development phase of vaccine candidates to obtain information on potential degradation pathways, support analytical methods development, and identify potential vaccine stabilizers and optimal condi- tions for long-term storage. The regulatory guidelines for forced degradation regarding biolog- ics have few to no procedural instructions on how to approach forced degradation studies. In this review, we provide an overview of methods used to study forced degradation in vaccines, mechanisms of degradation, analytical methodology, forced degradation examples conducted for vaccine products, and a summary of stabilizers that are used to influence the results of new vaccine candidates.