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Pneumatic tube transport of trastuzumab in IV bags—Effect of headspace and surfactant on subvisible particle formation
Lund University, Sweden.
RISE Research Institutes of Sweden, Life Science, Chemical Process and Pharmaceutical Development.
Uppsala University, Sweden.
AstraZeneca, USA.
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2025 (English)In: Journal of Pharmaceutical Sciences, ISSN 0022-3549, E-ISSN 1520-6017, Vol. 114, no 2, p. 1142-1151Article in journal (Refereed) Published
Abstract [en]

In hospitals, IV bags can be prepared in advance for logistical and microbial safety reasons in a compounding unit and then transported to wards. Transport of protein drugs using a pneumatic tube system has been reported to result in high particle levels. In this study, pneumatic tube transport of trastuzumab in saline polyolefin bags was compared to delivery by hospital porters using an electric platform truck in an underground tunnel system. The transport was tracked using designed smart labels. Two strategies to prevent particle formation, removing headspace and adding the surfactant polysorbate 20 were evaluated. The transport by pneumatic tube had a higher level of shock and vibration than truck delivery. The total particle count measured using flow microscopy also increased more for pneumatic transport than for transport by vehicle. Removing the headspace decreased particle formation for both transports. Surfactant decreases particles over 10 µm for trastuzumab in saline IV bags but increases the total particle levels. Pneumatic tube transport of saline in polyolefin bags resulted in high particle levels and surfactant increased the total particle count. Removing headspace is a measure that can be incorporated into compounding practices to cover for inadequate surfactant levels in IV bags. 

Place, publisher, year, edition, pages
Elsevier B.V. , 2025. Vol. 114, no 2, p. 1142-1151
Keywords [en]
monoclonal antibody; surfactant; trastuzumab; Article; chromatography; controlled study; drug delivery system; drug stability; female; human; liquid chromatography-mass spectrometry; physiological stress; quality control; vibration
National Category
Chemical Engineering
Identifiers
URN: urn:nbn:se:ri:diva-78039DOI: 10.1016/j.xphs.2024.12.003Scopus ID: 2-s2.0-85215386172OAI: oai:DiVA.org:ri-78039DiVA, id: diva2:1998088
Note

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement N°101007939 (RealHOPE). This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. Content of this [publication/presentation/etc.] reflects only the author’s view and the JU is not responsible for any use that may be made of the information it contains.

Available from: 2025-09-15 Created: 2025-09-15 Last updated: 2025-09-23Bibliographically approved

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Elofsson, Ulla

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