Patient-Centric Insights into Clinical In-Use Stability of Protein Drug Products

Intravenous administration of antibody-based drug products involves multiple clinical in-use steps that directly influence product stability, material compatibility, dosing accuracy, and ultimately patient safety and experience. This study systematically evaluates over 90 commercially available antibody-based drug products administered via IV infusion, focusing on key clinical in-use parameters that affect both formulation performance and patient-centered delivery.

Using statistical tools, we analyzed variability in storage and operational conditions, drug concentration ranges, dosing regimens, infusion rates, and priming and flushing procedures. Material compatibility was comprehensively assessed, including diluent selection, syringe and needle types, IV bag and line materials, in-line filters, pumps, and venous access devices. The findings reveal prevalent clinical practices and commonly used material options, providing a practical reference for formulation scientists and pharmacy teams designing first-in-human clinical in-use studies or drafting initial pharmacy manuals for antibody-based products.

The presentation also highlights strategies for low-dose protein drug administration, including case examples illustrating the impact of IV administration sets and in-line filter types in clinical trials requiring low doses with significant drug–device interactions. In addition, we will address analytical challenges in clinical in-use stability assessment caused by diluent or impurity interferences and share practical approaches for identifying and mitigating these risks.