Consumers may take it for granted that a therapeutic drug product in the household medicine cabinet effectively does what its label claims. Likewise, medical professionals expect prescribed products to comply with efficacy, safety and stability requirements. The confidence of both parties is based on the expectation that biopharmaceutical companies thoroughly test therapeutic products long before they reach the market.

Considering stability, biopharmaceutical manufacturers need to know that as a product sits on a shelf, it won’t lose its effectiveness or degrade into something dangerous to consume. For finished product stability testing, a product is stored in controlled conditions and then periodically removed from those conditions and examined to ensure it adheres to standards. Various characteristics are measured to create a degradation line over the shelf life of a product. In some cases, a study may span many years.

For a substance in development and not yet approved for clinical use, companies cannot wait years due to competitive pressures, market demands and the clock ticking on patent expiration dates. To accelerate the stability testing process, scientists put the substance in stress conditions such as high humidity and temperature to highlight stability issues sooner.

If they have standardized technology, practices and data to support an integrated approach to stability testing and analytics, they may also use virtual models. Virtual testing, also known as in silico testing, can often predict stability issues early in the research and discovery phases.