Avoid delays in the creation of your biologic by selecting an Experienced partner to do stability testing. For over two decades, we have helped clients develop and execute CGMP study plans that meet worldwide regulatory requirements. We offer a transparent, controlled, and clearly recorded course for each our equilibrium studies, with comprehensive record keeping and reporting.Protein, peptide, vector, and plasmid products are especially Sensitive to environmental elements. Stability testing studies are conducted to evaluate biopharmaceutical products under different environmental conditions over a particular timeframe. The results determine recommended storage and dispatch conditions for drug substances and products, and determine the suitable shelf life or retest period.
Real-time and Accelerated Stability Testing
Shelf life is commonly estimated using results from both real-time stability and accelerated stability tests. In real-time Stability Testing, a product is stored at recommended storage conditions and tracked until it fails product specifications. In accelerated stability testing, a product is stored at elevated stress conditions e.g., high temperatures and/or humidity. Degradation in the recommended storage conditions can then be predicted with known relationships between the acceleration variable as well as the degradation rate.
Forced Degradation Studies
We encourage forced degradation programs with equilibrium studies That use extreme storage conditions to be able to increase the rate of degradation. Due to the non-linear character of protein degradation kinetics, these studies have limited value in shelf-life forecast for biopharmaceutical products. However, because they supply information on product breakdown and degradation pathways, forced degradation studies are especially helpful in early drug development to increase formulation and help with the determination of storage requirements to control product stability.A stability study that is conducted under long-term Problems To evaluate the stability of a product batch in its bulk container. This applies to situations in which a drug product may be stored in A bulk container for a time period before its placement into end-user packaging. A research that is conducted to determine the period of time a Product remains appropriate to be used after its container system was opened.