Impact of Closed System Transfer Device (CSTD) Handling Procedure for Low-Transfer-Volume Dose Preparation of Biologic Drug Products.

Many challenges have been identified for ensuring compatibility of closed system transfer devices (CSTDs) with biologic drug products. One challenge is large hold-up volumes (HUVs) of CSTD components, which can be especially problematic with early-stage biologics when low transfer volumes smaller than the nominal fill volume may be used to achieve a wide range of doses with a single drug product configuration. Here, we identified possible CSTD handling techniques during dose preparation of a drug product requiring small volume transfers during reconstitution, intermediate dilution, and dilution in an IV bag, and systematically evaluated the impact of these handling procedures on the ability to deliver an accurate dose to the next step.