Gene Therapy In-Use And Device Compatibility Studies

As gene therapies become increasingly complex and personalized, ensuring the safety, stability, and efficacy of these products throughout handling and administration is more critical than ever. In-use and device compatibility studies play a vital role in the development lifecycle of gene therapy products by simulating real-world preparation and delivery conditions. These studies evaluate how therapeutics hold up after thawing, dilution, storage, or exposure to materials in delivery systems—such as syringes, IV bags, and catheters—used during dosing.

Explore the scientific and regulatory framework for conducting effective in-use and compatibility studies, with a focus on gene therapies delivered via viral and non-viral vectors. Highlighting key design considerations, such as hold times, flow rates, vector degradation pathways, and analytical methods for assessing product integrity, potency, and stability.

For developers seeking regulatory approval and clinical success, these studies are essential to optimizing processes. Learn how rigorous compatibility testing can ensure safe gene therapy delivery.