Assessing shelf life using real-time and accelerated stability tests

Although Accelerated Tests Are Needed, Real-Time Tests Are the Ultimate Proof

Biopharmaceutical products in storage change as they age, but they are considered to be stable as long as their characteristics remain within the manufacturer's specifications. The number of days that the product remains stable at the recommended storage conditions is referred to as the shelf life. The experimental protocols commonly used for data collection that serve as the basis for estimation of shelf life are called stability tests.

Shelf life is commonly estimated using two types of stability testing: real-time stability tests and accelerated stability tests. In real-time stability testing, a …