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Aggregation of monoclonal and bispecific antibodies during pneumatic tube transport of IV bags in a hospital: Mitigation by polysorbate 80, poloxamer 188, and headspace removal
Journal article   Peer reviewed

Aggregation of monoclonal and bispecific antibodies during pneumatic tube transport of IV bags in a hospital: Mitigation by polysorbate 80, poloxamer 188, and headspace removal

Parham Parnian, Annette M Medina, Nidia Gonzalez Lopez, Katiria Flores, Lakyn Lucio, Lauren Reist, Mark A Arnold, Stanley C Kwok and Reza Nejadnik
Journal of pharmaceutical sciences, Vol.115(6), 104264
06/2026
DOI: 10.1016/j.xphs.2026.104264
PMID: 41905654

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Abstract

Pneumatic tube systems (PTS) are being increasingly used in hospitals to rapidly transport critical packages, but their mechanical stresses raise concerns for the safe transport of protein therapeutics. This study examined the impact of the PTS at the University of Iowa Hospital on protein admixtures of a monoclonal antibody (mAb) and a bispecific antibody (BsAb) prepared in IV-bags and benchmarked it against manual transport and shaking. The PTS ride imposed sharp shocks nearly tenfold higher than either shaking or manual transport. Flow imaging microscopy revealed increased microparticle formation for both proteins, though with distinct profiles. The mAb generated more small aggregates, whereas the BsAb produced fewer yet larger particles. Surfactants reduced particle formation, with Polysorbate 80 (PS80) more effective than poloxamer 188. For BsAb, PS80 lowered microparticles by ∼70% but failed to prevent large particle formation, in contrast to its near-complete protection for mAb. Headspace removal further reduced particle formation, fully preventing the formation of large aggregates when combined with PS80. Size exclusion chromatography revealed no detectable increase in soluble aggregates or monomer loss. These findings show that PTS presents a unique stress profile not replicated by shaking and highlight the need for case-by-case evaluation of PTS compatibility based on protein, container, and excipients.
polysorbate 80 nanoparticles IV bags protein aggregation bispecific antibody pneumatic tube system transportation microparticles poloxamer 188 headspace monoclonal antibody

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