A Novel Laboratory-Scale Pneumatic Tube System (PTS) to Assess the Impact of Hospital PTS Transportation on the Product Quality of Therapeutic Monoclonal Antibodies

A large number of therapeutic monoclonal antibody (mAb) drug products are administered to patients via intravenous (IV) infusion. For IV administration in hospitals, the mAb drug product is typically diluted with a commercially available compatible diluent, such as normal saline or 5% dextrose solution, contained in an IV infusion container (e.g., an IV bag). The site of IV administration may be distant from the preparation site. In such cases, the IV bag containing the dosing solution may be transported manually, which can be time-consuming.

Many hospitals worldwide have installed and use a pneumatic tube system (PTS) for rapid transport of lab specimens, blood products, and other supplies between departments. This method is more convenient, quick, and efficient compared to manual transportation. Consequently, there is increasing demand to use hospital PTS for transporting mAb dosing solutions contained in IV infusion bags during clinical trials or for commercial use. However, the impact of PTS transportation conditions on the product quality of a given mAb needs thorough evaluation before implementing this mode of transportation.

Designing and executing hospital PTS transportation studies for mAb drug products intended for IV administration poses several challenges for pharmaceutical companies. Accessing hospital PTSs can be difficult due to contractual and legalistic requirements as well as scheduling challenges within a hospital, associated with potential disruptions to the already busy transportation of critical hospital samples. Additionally, a given hospital PTS may be located far from the pharmaceutical company, creating logistical hurdles and leading to the exposure of test materials to additional transportation that may not accurately represent the actual scenario. As a result, utilizing a hospital PTS requires substantial resources and time. Conversely, conducting studies using a laboratory method requires fewer resources and time and may allow for widespread application across hospitals worldwide.

In our study, a novel laboratory method was designed and evaluated to characterize the impact of hospital PTS transportation methods on the product quality of a therapeutic test mAb. The impact on product quality caused by hospital PTS transportation was found to be comparable to that caused by the laboratory method. This presentation will demonstrate a practical way to design a robust and comparable laboratory method and study to accurately assess the impact of hospital PTS transportation on mAb product quality and establish safe transportation and handling practices for therapeutic mAb drug products in hospitals.