Stability Characterization

Jerrycret6808 Jan, 2024Technology

Stability Testing Programs Stability studies during biosimilar development are critical along a candidate's road to becoming a commercial drug. Based on the ICH Q5C guidance, the stability analysis tests the potency, purity, molecular characterization, and product characteristics of a biosimilar candidate under various environmental conditions over a specific timeframe. Many factors can affect the stability of biologics and biosimilars, therefore, there is complex analytical methodologies to profile the stability characteristics. A range of studies must be designed to provide assurance of the stability of the product.