The timely distribution of medicines to patients is an essential part of the patient care plan, and maximising efficiency in the logistics systems behind these movements is vital to minimise cost. Before drones can be used for moving medical cargo, medical regulatory authorities require assurance that the transported products will not be adversely affected by in-flight conditions unique to each drone. This study set out to (i) quantify the vibration profile by phases of flight, (ii) determine to what extent there were significant differences in the observed vibration between the phases, and (iii) assess the quality of flown monoclonal antibody (mAb) infusions used in the treatment of cancer. Vibrations emanating from the drone and transmitted through standard medical packaging were monitored with the storage specifications for mean kinematic temperature (2–8 °C) being met. Vibration levels were recorded between 1.5 and 3 g, with the dominant octave band being 250 Hz. After 60 flights, the quality attributes of flown infusions regarding size integrity were found to be no different from those of the control infusions. For example, the particle size had a variation of less than 1 nm; one peak for Trastuzumab was 14.6 ± 0.07 nm, and Rituximab was 13.3 ± 0.90 nm. The aggregation (%) and fragmentation (%) remained at 0.18 ± 0.01% and 0.11 ± 0.02% for Trastuzumab, 0.11 ± 0.01% and 2.82 ± 0.15% for Rituximab. The results indicated that in the case of mAbs, the quality assurance specifications were met and that drone vibration did not adversely affect the quality of drone-flown 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.

Background: Drone transport regulations in Europe require a crash-protected container (CPC) to be used for the carriage of dangerous goods. With increasing interest in the use of drones for medical logistics, the motivation behind this research was to investigate whether the existing approved medical carriers could also pass as CPCs. To date, there has been little practical experimentation on or theoretical research into the crash protection performance of medical containers. Methods: Addressing this gap, this paper reports findings from a series of drop test experiments to investigate the crashworthiness of a standard medical carrier bag used by the National Health Service (NHS) in the UK. Th drop tests were performed from heights of up to 122 m using standard medical carriers containing bags of dyed saline to examine the robustness of the carrier and whether it could contain any leakages, a key requirement for transporting dangerous goods. Results: The tests found that the medical carrier failed on some drops, with the zipped lid being identified as the main weakness. Conclusions: A new understanding of the carrier’s terminal velocity, impact acceleration, and failure mechanisms were gained and subsequent strengthening and waterproofing remedial measures recommended. New insights and practical recommendations are provided relating to performing formal drop tests and how to conduct these using a drone.

Therapeutic monoclonal antibodies essential for cancer treatments, are sensitive biomolecules requiring reconstitution in infusion bags, and administration within hours. While drone transportation presents a promising solution for reaching remote healthcare facilities, it introduces mechanical stresses that can compromise mAb stability, leading to protein unfolding and aggregation. This study aimed to evaluate the stability of reconstituted Opdivo® (nivolumab) across vibrations modelling flight. Two different reciprocating shakers were used to simulate predominant frequencies of drone-induced vibrations in a controlled laboratory setting, employing analytical techniques (UV, DLS & SE-HPLC) to assess critical parameters and support the development of risk assessments for drone transportation. Nivolumab infusions remained stable under simulated drone vibrations, with all quality attributes meeting acceptance criteria. Samples exposed to varying frequencies 8, 63, 125 Hz for 30 min; 63 Hz for 1, 2, 3 h; a 43-minute drone flight, and prepared at different concentrations (0.48, 0.86, 1.24 mg/mL) showed no significant differences from controls. Two of the three samples subjected to 125 Hz vibration for 30 min exhibited a minor increase in monomer content (≤0.16 %, p = 0.003) on Day 2, accompanied by a 3 nm reduction in particle size. However, these changes remained within pharmaceutically acceptable limits and showed no evidence of functional compromise compared to controls. The particle size shift dissipated after 24 h of storage, suggesting a reversible, vibration-induced dissociation of oligomeric species. Understanding, the impact of flight on product characteristics and stability is important. The results show that Opdivo® is not affected by the vibrations generated by the various stages of drone flight. This paper establishes a reproducible framework for evaluating monoclonal antibody stability under simulated transport conditions, contributing to the development of safer and more efficient delivery methods in cancer care.

Using Uncrewed Aerial Vehicles (UAVs), commonly known as drones, for logistics is an area of interest that can involve payloads containing substances classified by the United Nations as dangerous goods (DGs) when transported by air, particularly for medical use cases. Drones are a relatively new logistics mode, and the associated regulatory environment governing their use is also new and evolving. This research investigated the potential for drone payloads to contain DGs and identified the associated challenges, both legislative and practical, facing the drone logistics sector. This was achieved through a review of DG regulations, an assessment of medical payloads to quantify potential to contain DGs, and practical insight gained from developing a novel medical carrier compatible with regulations governing DG transportation by drone. Results suggest that, from an analysis of over 44,000 safety data sheets, ~10% of medicines were classified as DGs and that stipulated procedures to demonstrate compliance with DG regulations are unlikely to be scalable in accordance with the forecast expansion of the sector due to their challenging and resource intensive requirements.