Stability testing is a vital part of product development since prior to approval a detailed study of product stability should be finalised and conducted in consideration of relevant guidelines. Product stability should be proved under various environmental conditions (e.g. as temperature, light, relative humidity, pH) over a specific timeframe. These tests permit to understand the degradation pathways in order to find the storage conditions that maintains the Critical Quality Attributes (CQAs) throughout the product shelf life.
Stability testing and stress testing (forced degradation studies) should be started ideally during development phases as soon as early development material is available. This not only allows to identify the most robust and stable formulation but also ensures that the product will remain stable when used in the lab, during shipments and during stability studies. Moreover, stress testing will generate by-products that are the basis for a robust and reliable analytical method development programme.
Rodon in the stability programs provides the complete range of ICH stability conditions and lengths of storage to meet your requirements. Additionally, Rodon carries out the development of test methods and protocols to assure the accurate profile of your biopharmaceutical product.
Our stability studies include:
• Long-term drug stability;
• Accelerated stability studies;
• In-use studies;
• Freeze-thaw studies.
Evaluation of identity, purity, integrity and potency of the product is conducted in each time point defined. Rodon is able to conduct real time and accelerated studies based on your defined requirements with time points for 0, 1, 3, 6 months, 1 year, or as many as 2–5 years.
Our experience team may help designing the study to assure that your stability study is conducted under the appropriate conditions for your biologic. A full range of analytical methods is available including specific in-vitro bioassays for potency evaluation.
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Looking for additional services? We offer even more services than listed, contact us to find out how we can assist you. Using latest advances in Protein Technologies Rodon Biologics strives to provide the highest quality custom protein services in the industry. We work closely with you, analyze your project at the planning stage and take several approaches to ensure you get the results you are looking for.Know More