Division of BioTherapeutics, Leiden Academic Centre for Drug Research, Leiden University, Leiden, the Netherlands; Department of Clinical Pharmacology and Pharmacy, Amsterdam University Medical Center, Location Vrije Universiteit, Amsterdam, the Netherlands.
Division of BioTherapeutics, Leiden Academic Centre for Drug Research, Leiden University, Leiden, the Netherlands.
J Pharm Sci. 2024 Jul;113(7):1816-1822. doi: 10.1016/j.xphs.2024.04.002. Epub 2024 Apr 4.
In the field of healthcare logistics, the reliance on conventional transport methods such as cars for the delivery of monoclonal antibodies (mAbs) is susceptible to challenges posed by traffic and infrastructure, leading to increased and unpredictable transport times. Recognizing the potential role of drones in mitigating these challenges, we aimed to investigate the impact of medical drone transport on the stability of mAbs. Compromised stability could lead to aggregation and immunogenicity, thereby jeopardizing the efficacy and safety of mAbs. We studied the transportation of vials as well as ready-to-administer infusion bags with blinatumomab, tocilizumab, and daratumumab. The methodology involved the measurement of both temperature and mechanical shock during drone transport. Moreover, the analytical techniques High Performance Size-Exclusion Chromatography (HP-SEC), Dynamic Light Scattering (DLS), Light Obscuration (LO), Micro-Flow Imaging (MFI), and Nanoparticle Tracking Analysis (NTA) were employed to comprehensively assess the presence of aggregates and particle formation. The key findings revealed no significant differences between car and drone transport, indicating that the stability of mAbs in both vials and infusion bags was adequately maintained during drone transport. This suggests that medical drones are a viable and reliable means for the inter-hospital transport of mAbs, paving the way for more efficient and predictable logistics in healthcare delivery.
在医疗保健物流领域，依赖传统的运输方式（如汽车）来运送单克隆抗体（mAbs）容易受到交通和基础设施带来的挑战的影响，导致运输时间增加且不可预测。鉴于无人机在缓解这些挑战方面的潜在作用，我们旨在研究医疗无人机运输对 mAbs 稳定性的影响。稳定性受损可能导致聚集和免疫原性，从而危及 mAbs 的疗效和安全性。我们研究了带有blinatumomab、tocilizumab 和 daratumumab 的小瓶和即用型输液袋的运输。该方法涉及在无人机运输过程中测量温度和机械冲击。此外，还使用了高效体积排阻色谱法（HP-SEC）、动态光散射（DLS）、光遮挡（LO）、微流成像（MFI）和纳米颗粒跟踪分析（NTA）等分析技术，全面评估聚集物和颗粒形成的存在。主要发现表明，汽车和无人机运输之间没有显著差异，这表明在无人机运输过程中，小瓶和输液袋中的 mAbs 稳定性得到了充分维持。这表明医疗无人机是 mAbs 医院间运输的一种可行且可靠的方式，为医疗保健提供更高效和可预测的物流铺平了道路。
