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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 imp...

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Autores principales: Zhu, Wanqing, Oakey, Andy, Royall, Paul G., Waters, Tim P., Cherrett, Tom, Theobald, Katherine, Bester, Ans-Mari, Lucas, Robert
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9821719/
https://www.ncbi.nlm.nih.gov/pubmed/36607896
http://dx.doi.org/10.1371/journal.pone.0278873
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author Zhu, Wanqing
Oakey, Andy
Royall, Paul G.
Waters, Tim P.
Cherrett, Tom
Theobald, Katherine
Bester, Ans-Mari
Lucas, Robert
author_facet Zhu, Wanqing
Oakey, Andy
Royall, Paul G.
Waters, Tim P.
Cherrett, Tom
Theobald, Katherine
Bester, Ans-Mari
Lucas, Robert
author_sort Zhu, Wanqing
collection PubMed
description 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.
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spelling pubmed-98217192023-01-07 Investigating the influence of drone flight on the stability of cancer medicines Zhu, Wanqing Oakey, Andy Royall, Paul G. Waters, Tim P. Cherrett, Tom Theobald, Katherine Bester, Ans-Mari Lucas, Robert PLoS One Research Article 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. Public Library of Science 2023-01-06 /pmc/articles/PMC9821719/ /pubmed/36607896 http://dx.doi.org/10.1371/journal.pone.0278873 Text en © 2023 Zhu et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Zhu, Wanqing
Oakey, Andy
Royall, Paul G.
Waters, Tim P.
Cherrett, Tom
Theobald, Katherine
Bester, Ans-Mari
Lucas, Robert
Investigating the influence of drone flight on the stability of cancer medicines
title Investigating the influence of drone flight on the stability of cancer medicines
title_full Investigating the influence of drone flight on the stability of cancer medicines
title_fullStr Investigating the influence of drone flight on the stability of cancer medicines
title_full_unstemmed Investigating the influence of drone flight on the stability of cancer medicines
title_short Investigating the influence of drone flight on the stability of cancer medicines
title_sort investigating the influence of drone flight on the stability of cancer medicines
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9821719/
https://www.ncbi.nlm.nih.gov/pubmed/36607896
http://dx.doi.org/10.1371/journal.pone.0278873
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