Understand Your Stability Programs

A stability program is a structured, protocol-driven process essential to the development and lifecycle management of pharmaceutical and biologic products. Its primary purpose is to evaluate how a product's quality attributes—such as potency, purity, and overall integrity—change over time under various environmental conditions. This is especially critical for biologics, which can degrade over time and potentially become unsafe or ineffective.

The program begins with defined materials, including drug substances (DS), drug products (DP), intermediates, and starting materials. These materials are subjected to defined storage conditions such as specific temperatures, humidity levels, packaging types, and even orientation. In addition to environmental factors, the program incorporates other parameters like pull/testing dates, statistical analysis, and testing windows to ensure comprehensive data collection. Importantly, conducting a stability program is not just best practice—it’s a regulatory requirement. Regulatory agencies mandate that manufacturers demonstrate how storage conditions and time impact product quality to justify final storage recommendations and shelf life claims.

If you're developing or managing pharmaceutical or biologic products, now is the time to ensure your stability program is robust, compliant, and optimized.