Gene therapy in-use and device compatibility studies

Introduction 

In-use stability and compatibility studies are an important part of the biotherapeutic development life cycle to determine and support product safety. These studies assess the impact on product quality by simulating real-world sample handling practices. Pharmaceutical products require some degree of processing, such as reconstitution, dilution or storage, prior to dosing patients. Biotherapeutics also come into contact with multiple different materials and components of the delivery system before being administered to the patient. In-use stability studies demonstrate the stability of the biotherapeutic during its intended in-use conditions and time frame by assessing the product before and after the sample handling process. Compatibility studies confirm the integrity of the product following exposure to different components, materials and diluents that may be used in processing and administration. These studies demonstrate that the product remains within its physical, chemical, and biological specifications and retains its safety and efficacy.