Sr. Scientist II Abbvie South San Francisco, California
Closed system transfer devices (CSTDs) are often used for dose preparation of both hazardous drugs and oncology investigative products regardless of the hazard classification. One challenge with CSTDs is hold-up volume (HUVs) of individual components; the impact of HUV on dose accuracy when using CSTDs with low-dose (low transfer volume) biologic drug products is previoulsy unexplored. Here, we systematically evaluate the impact of CSTD handling techniques on the dose accuracy when working with low-dose lyophilized drug products that require complex dilution schemes and small transfer volumes between dose preparation steps. We found that to ensure accurate dosing with low transfer volumes of drug product, a substantial level of detail is required for CSTD handling instructions. Standard procedures can lead to significant under- or over-dosing with small transfer volumes, depending on the CSTD HUVs and drug-product specific transfer volumes. We identify mitigation techniques to ensure dose accuracy and explore potential drawbacks.
Learning Objectives:
Introduce closed system transfer devices (CSTDs), who uses them, and how they are being used for IV bag dose preparation.
Understand challenges with using CSTDs with biologic drug products, particularly due to high hold-up volume (also called priming volume, dead volume).
Identify handling procedures during dose preparation of low-dose (low transfer volume) biologic drug products that can ensure dose accuracy in most situations.
Explore possible drawbacks to mitigation steps taken to ensure dose accuracy.
Describe impact of different handling procedures theoretically.