Scientific Publications by FDA Staff

Biologicals 2009 Nov;37(6):369-78

Goals of stability evaluation throughout the vaccine life cycle.

Krause PR

Stability studies play a critical role in assuring product quality at all points in the vaccine life cycle. At and after licensure, stability studies on quality attributes (including potency) provide a critical link between marketed and clinically evaluated vaccine product, addressing important regulatory concerns by assuring that product quality is maintained throughout the dating period. During development, stability studies are done to assure product quality and to obtain the data needed to support licensure. Stability studies may also be performed after licensure to assure that product continues to perform as it did pre-licensure, as well as to evaluate the effect on product quality of deliberately introduced manufacturing changes. At each phase in the product life cycle, it is important to consider the goals of stability evaluation and to perform appropriate statistical analyses in order to assure and reach appropriate conclusions about product quality.