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

Abstract

The rapid and efficient transportation of therapeutic monoclonal antibody (mAb) dosing solutions, prepared in intravenous (IV) infusion containers (e.g., IV bags), from pharmacy departments to target locations within hospital campuses globally requires the use of pneumatic tube systems (PTSs). Evaluating the impact of hospital pneumatic tube system (PTS) transportation on the quality attributes of mAb dosing solutions poses significant challenges for pharmaceutical companies. Herein, we present a novel, first-of-its-kind laboratory-scale PTS transportation model capable of assessing the effects of hospital PTS transportation on the product quality of therapeutic mAbs. The laboratory-scale PTS transportation model generated shock and vibration stresses comparable to those experienced in a model hospital PTS transportation. The impact on the product quality of a test mAb due to model hospital PTS transportation was comparable to that observed with laboratory-scale PTS transportation. We found that the impact of PTS transportation on product quality was influenced by the cumulative stress levels experienced by the mAb. Additionally, the product quality was affected by the type of surfactant. The effectiveness of removing air headspace from an IV bag prior to PTS transportation, as a means to mitigate the product quality impact, was also influenced by cumulative PTS stress levels. PTS transportation, with or without stabilizing surfactant in the dosing solution, did not negatively affect the conformational stability, the tertiary structure, or the potency of the test mAb. This study demonstrates a practical approach for designing laboratory-scale PTS transportation studies to assess the risk to product quality of a given mAb due to hospital PTS transportation, determine the residual surfactant (e.g., polysorbate 80/PS80) level needed for protein stabilization, and establish safe transportation and handling practices when using hospital PTS systems.