Impact of pneumatic tube transportation on the aggregation of monoclonal antibodies in clinical practice.

Autor: Cohrs M; Laboratory of General Biochemistry and Physical Pharmacy, Ghent University, Ottergemsesteenweg 460, 9000 Ghent, Belgium., Clottens N; Pharmacy Department, Ghent University Hospital, Corneel Heymanslaan 10, 9000 Ghent, Belgium., Ramaut P; Pharmacy Department, Ghent University Hospital, Corneel Heymanslaan 10, 9000 Ghent, Belgium., Braeckmans K; Laboratory of General Biochemistry and Physical Pharmacy, Ghent University, Ottergemsesteenweg 460, 9000 Ghent, Belgium., De Smedt S; Laboratory of General Biochemistry and Physical Pharmacy, Ghent University, Ottergemsesteenweg 460, 9000 Ghent, Belgium., Bauters T; Pharmacy Department, Ghent University Hospital, Corneel Heymanslaan 10, 9000 Ghent, Belgium. Electronic address: tiene.bauters@uzgent.be., Svilenov HL; Laboratory of General Biochemistry and Physical Pharmacy, Ghent University, Ottergemsesteenweg 460, 9000 Ghent, Belgium; Biopharmaceutical Technology, TUM School of Life Sciences, Technical University of Munich, Emil-Erlenmeyer-Forum 5, 85354 Freising, Germany. Electronic address: hristo.svilenov@tum.de.
Jazyk: angličtina
Zdroj: European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences [Eur J Pharm Sci] 2025 Jan 01; Vol. 204, pp. 106952. Date of Electronic Publication: 2024 Oct 29.
DOI: 10.1016/j.ejps.2024.106952
Abstrakt: Postproduction handling and in-hospital transportation of antibody drugs cause mechanical stress, including interfacial and shear stress, that can induce antibody unfolding and aggregation. The handling practices differ significantly between hospitals and the impact on protein stability is unknown. For example, the mechanical stress caused by transport via pneumatic tube systems (PTS) on therapeutic antibody aggregation is a potential safety and quality gap. The aim of this study was to investigate whether mechanical stress and PTS transportation in a hospital cause aggregation of five commonly used antibody drugs diluted in infusion bags. Orthogonal analytical methods showed that the handling and PTS transportation in this hospital did not cause aggregation of the investigated mAbs. The absence of aggregation could be explained by the reduction of interfacial stress due to headspace removal from the infusion bags and a mechanical sensor indicated that there was also only a moderate amount of mechanical stress caused by transportation with this particular PTS. Although this case study focuses on five antibody drugs and the practices in one hospital, the work demonstrates how to evaluate whether other handling and transportation practices cause significant mechanical stress that could compromise the quality and safety of antibody drugs.
(Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
Externí odkaz: