Investigating the influence of drone flight on the stability of cancer medicines
Investigating the influence of drone flight on the stability of cancer medicines
Monoclonal Antibodies (mAbs) are being used in the treatment of both malignant and non-malignant diseases and whilst highly effective, certain products have very short expiry times. Clinical deterioration and supply chain disruption can often lead to wastage and there is a need to reduce this by improving efficiency in logistics practices between manufacturing sites and administration locations. This study aimed to investigate the influence of drone flight on the stability of cancer medicines. Clinically expired, premanufactured monoclonal antibodies (mAbs) were investigated, contained inside instrumented Versapaks, and flown in a Skylift (Mugin) V50 vertical take-off and landing drone through seven phases of flight, (take-off, hover, transition, cruise, transition, hover, and landing). Storage specifications (2-8°C) were met, and any vibrations emanating from the drone and transmitted through the packaging during flight were monitored using accelerometers. Vibration occurred largely above 44 Hz which was consistent with rotor speeds during operation and was significantly greater in amplitude during transition than in forward flight or in hover. Bench experiments validated assurance practices, exploring the edge-of-quality failure by applying extremes of rotational vibration to the mAbs. Aggregation and fragmentation represented a loss of quality in the mAbs and would pose a risk to patient safety. No significant difference was identified in the aggregation and fragmentation of all flown mAbs samples, indicating structural integrity. Flown mAbs in their infusion bags had similar particle sizes compared to controls, (Bevacizumab 11.8±0.17 nm vs. 11.6±0.05 nm, Trastuzumab 11.2±0.05 nm vs. 11.3±0.13 nm, Rituximab 11.4±0.27 nm vs. 11.5±0.05 nm) and aggregate content (Bevacizumab 1.25±0.03% vs 1.32±0.02% p=0.11, Trastuzumab 0.15±0.06% vs. 0.16±0.06% p=0.75, Rituximab 0.11±0.02% vs. 0.11±0.01% p=0.73). The quality of the three mAbs was assured, suggesting that the V50 drone did not induce sufficient levels of vibration to adversely affect their quality.
VTOL, cancer, drones, healthcare, hospital, logistics, medicine, pharmacy, safety, transport, vibration analysis
Zhu, Wanqing
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Oakey, Andy
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Royall, Paul
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Waters, Tim
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Cherrett, Thomas
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Theobald, Katherine
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Bester, Ans-Mari
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Lucas, Robert
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6 January 2023
Zhu, Wanqing
011a289f-9f22-4743-af1c-68d7d7074d16
Oakey, Andy
dfd6e317-1e6d-429c-a3e0-bc80e92787d1
Royall, Paul
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Waters, Tim
348d22f5-dba1-4384-87ac-04fe5d603c2f
Cherrett, Thomas
e5929951-e97c-4720-96a8-3e586f2d5f95
Theobald, Katherine
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Bester, Ans-Mari
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Lucas, Robert
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Zhu, Wanqing, Oakey, Andy, Royall, Paul, Waters, Tim, Cherrett, Thomas, Theobald, Katherine, Bester, Ans-Mari and Lucas, Robert
(2023)
Investigating the influence of drone flight on the stability of cancer medicines.
PLoS ONE, 18 (1 January), [e0278873].
(doi:10.1371/journal.pone.0278873).
Abstract
Monoclonal Antibodies (mAbs) are being used in the treatment of both malignant and non-malignant diseases and whilst highly effective, certain products have very short expiry times. Clinical deterioration and supply chain disruption can often lead to wastage and there is a need to reduce this by improving efficiency in logistics practices between manufacturing sites and administration locations. This study aimed to investigate the influence of drone flight on the stability of cancer medicines. Clinically expired, premanufactured monoclonal antibodies (mAbs) were investigated, contained inside instrumented Versapaks, and flown in a Skylift (Mugin) V50 vertical take-off and landing drone through seven phases of flight, (take-off, hover, transition, cruise, transition, hover, and landing). Storage specifications (2-8°C) were met, and any vibrations emanating from the drone and transmitted through the packaging during flight were monitored using accelerometers. Vibration occurred largely above 44 Hz which was consistent with rotor speeds during operation and was significantly greater in amplitude during transition than in forward flight or in hover. Bench experiments validated assurance practices, exploring the edge-of-quality failure by applying extremes of rotational vibration to the mAbs. Aggregation and fragmentation represented a loss of quality in the mAbs and would pose a risk to patient safety. No significant difference was identified in the aggregation and fragmentation of all flown mAbs samples, indicating structural integrity. Flown mAbs in their infusion bags had similar particle sizes compared to controls, (Bevacizumab 11.8±0.17 nm vs. 11.6±0.05 nm, Trastuzumab 11.2±0.05 nm vs. 11.3±0.13 nm, Rituximab 11.4±0.27 nm vs. 11.5±0.05 nm) and aggregate content (Bevacizumab 1.25±0.03% vs 1.32±0.02% p=0.11, Trastuzumab 0.15±0.06% vs. 0.16±0.06% p=0.75, Rituximab 0.11±0.02% vs. 0.11±0.01% p=0.73). The quality of the three mAbs was assured, suggesting that the V50 drone did not induce sufficient levels of vibration to adversely affect their quality.
Text
journal.pone.0278873
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More information
Accepted/In Press date: 24 November 2022
Published date: 6 January 2023
Additional Information:
Funding Information:
TC: UK EPSRC-funded e-Drone project, EP/V002619/1, (www.e-drone.org) TC: UK Department for Transport Funded Future Transport Zones Solent project (www.solent-transport.com/ solent-future-transport-zone/). WZ: King’s-China Scholarship Council (K-CSC) PhD Scholarship Programme for Zhu, W. The funders were not directly involved in this research.
Publisher Copyright:
Copyright: © 2023 Zhu et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Keywords:
VTOL, cancer, drones, healthcare, hospital, logistics, medicine, pharmacy, safety, transport, vibration analysis
Identifiers
Local EPrints ID: 473634
URI: http://eprints.soton.ac.uk/id/eprint/473634
ISSN: 1932-6203
PURE UUID: 1796dcf4-6e68-45e3-a4be-1537043f982b
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Date deposited: 25 Jan 2023 17:48
Last modified: 12 Nov 2024 03:09
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Contributors
Author:
Wanqing Zhu
Author:
Andy Oakey
Author:
Paul Royall
Author:
Katherine Theobald
Author:
Ans-Mari Bester
Author:
Robert Lucas
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