Accelerated stability testing of bioproducts: attractions and pitfalls

Area of Science:

• Materials Science
• Chemical Engineering
• Food Science
• Pharmaceutical Science

Background:

• Accelerated testing is a common method for predicting product stability and shelf-life.
• Labile products in the food, pharmaceutical, and bioindustries are often subjected to high-temperature stress tests.
• Extrapolation of results from accelerated testing to normal storage conditions is standard practice.

Purpose of the Study:

• To highlight the potential pitfalls of accelerated testing for thermodynamically unstable amorphous solids.
• To emphasize the importance of understanding physical changes during heating for accurate extrapolation.
• To enable confident performance of accelerated testing by considering product-specific physical transformations.

Main Methods:

• Review of accelerated testing methodologies in various industries.
• Analysis of physical and chemical changes in amorphous solids under thermal stress.
• Discussion of extrapolation techniques and their limitations.

Main Results:

• Accelerated testing can yield misleading results for amorphous solids due to sudden physical or chemical changes.
• Thermodynamically unstable amorphous solids are particularly susceptible to these changes during heating.
• Knowledge of potential physical changes during heating is essential for reliable accelerated testing.

Conclusions:

• Understanding the physical behavior of products during heating is critical for accurate accelerated testing.
• Careful consideration of potential physical changes enhances the reliability of shelf-life and stability predictions.
• This knowledge allows for more confident application of accelerated testing protocols in industry.