Impact of pneumatic tube system transportation on product quality of therapeutic monoclonal antibody lyophilized and reconstituted drug products.

Pneumatic tube systems (PTSs) provide an efficient means of rapidly transporting samples within hospitals. The feasibility of using hospital PTSs to transport therapeutic monoclonal antibody (mAb) dosing solutions in intravenous infusion containers has been evaluated in recent years. In this study, we evaluated the impact of transporting therapeutic mAb drug products in vials-both lyophilized and reconstituted-via a laboratory-scale PTS that simulates typical hospital transport stresses, and assessed the resulting effects on product quality for two test mAbs. Samples were subjected to increasing cumulative PTS stress (transport distances of 586 m, 1,172 m, or 2,344 m) to represent typical hospital transportation scenarios and were assessed using multiple analytical methods. Mechanical shock and vibration caused breakage of lyophilized cakes and increased subvisible particle counts after reconstitution. For both mAbs, higher cumulative PTS stress (longer distances) was associated with higher subvisible particle counts, with mAb2 exhibiting greater sensitivity. PTS transport of the same mAb drug products after reconstitution had a negligible effect on subvisible particle counts. PTS transport had minimal impact on other quality attributes tested. Overall, these results contribute to the growing body of knowledge on PTS transport and indicate that PTS transport poses a significantly elevated risk to quality of lyophilized mAb products but may pose a low risk to quality of the reconstituted solution derived from the same lyophilized product. The decision to allow PTS transport for a given mAb product should be made on a case-by-case basis based on relative risk toward product quality impact for that particular mAb, which may be assessed using representative PTS stress conditions.