Spotlight on Clinical In-Use Parameters for Intravenous Infusion of Therapeutic Antibodies: A Systematic Review.

Intravenous (IV) administration of therapeutic antibodies requires multiple in-use steps to ensure safety, purity and potency before patient administration. This review systematically examines 93 FDA-approved therapeutic antibodies administered via IV infusion, focusing on critical clinical in-use parameters reported in their prescribing information. Key parameters analyzed include storage conditions, drug concentrations, dosing regimens, dilution and diluents, infusion rates, priming and flushing procedures, needle and syringe specifications, IV bag and line materials, infusion filters, pumps, and venous access devices. The statistical analysis of these parameters highlights the most commonly used industry practices, providing a comprehensive reference for formulation scientists designing clinical in-use studies or drafting pharmacy manuals for antibody-based products. Our findings show that saline is the most frequently recommended diluent, though some antibodies recommend alternative diluents such as dextrose solutions or lactated Ringer's solution. Similarly, filters are recommended for 65% of the analyzed drug products, yet variations exist in pore size and material recommendations. Additionally, oncology-related antibodies often require graduated infusion rates to mitigate infusion-related reactions, and 31% of antibodies suggest adjusting infusion rates based on patient tolerance. These findings highlight the need for systematic in-use studies covering various scenarios and clinical settings to establish evidence-based recommendations. Well-designed clinical in-use studies, coupled with well-structured pharmacy manuals that clearly outline in-use preparation steps, enhance clarity, reduce preparation errors, and improve workflow efficiency to ultimately ensure safe and effective IV administration of therapeutic antibodies.