Did you know that a drug candidate whose formulation development is supported by early in-use stability studies has a higher chance of making it through the clinic? Optimizing formulation and packaging to improve stability during use can lead to a higher-quality product. The early detection of in-use stability issues enables timely corrective action before the product is released for larger-scale clinical trials, reducing development costs.
ProJect Pharmaceutics CRO is an independent, European development partner offering in-use stability studies for injectable drug products from as early as alongside formulation development to as late as ahead of clinical trials. During formulation development we test early on i.e. compatibility with common infusion media as well as real-time stability of reconstituted lyophilization solution. We have the necessary laboratories, technical equipment, consumables and expertise to replicate the conditions for your clinical trial so that we can evaluate the stability of your drug in various formulations in real-life application scenarios, such as i.a.:
- Compatibility with in-use consumables (CSTDs, syringes, IV bags, IV lines, etc.)
- Storage stability (hold times)
- Simulation of handling steps and administration procedure
- Evaluation of adsorption phenomena and recovery from IV equipment
- Dilution study for dose simulation
