Stability testing: An Essential study for Vaccine Formulation Development
Amitkumar J. Vyas, Sinchan M. Patel, Ashok B. Patel, Ajay I. Patel, Nilesh K. Patel, Suuny Shah, Devang Sheth
Abstract
Forced degradation studies are carried out at a more severe condition than accelerated conditions. Stress studies for vaccines are carried out in the early stage of development. By conducting stress studies, we can know the chemical behavior of our molecule which is important while developing formulation, packaging, transportation, storage, etc. there are general regulatory guidelines are available for conducting forced degradation studies but there is no sufficient information provided about how to perform forced degradation studies. Thus, this review discussed stress testing studies of vaccines, mechanisms of vaccine degradation, also analytical methods which are helpful to develop a method for forced degradation.