The concept of transporting medical products by drone is gaining a lot of interest amongst the medical and logistics communities. Such innovation has generated several questions, a key one being the potential effects of flight on the stability of medical products. The aims of this study were to quantify the vibration present within drone flight, study its effect on the quality of the medical insulin through live flight trials, and compare the effects of vibration from drone flight with traditional road transport. Three trials took place in which insulin ampoules and mock blood stocks were transported to site and flown using industry standard packaging by a fixed-wing or a multi-copter drone. Triaxial vibration measurements were acquired, both in-flight and during road transit, from which overall levels and frequency spectra were derived. British Pharmacopeia quality tests were undertaken in which the UV spectra of the flown insulin samples were compared to controls of known turbidity. In-flight vibration levels in both the drone types exceeded road induced levels by up to a factor of three, and predominant vibration occurred at significantly higher frequencies. Flown samples gave clear insulin solutions that met the British Pharmacopoeia specification, and no aggregation of insulin was detected.
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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