Benchmarking of a novel multiparameter sensor for nanomedicines

脂质纳米颗粒和脂质体提供了一种革命性的方法，以可控的方式提供以前不可行的治疗方法，以实现更有效的治疗。这些纳米材料允许增加对靶组织的渗透，改变生物利用度，并具有改善体内靶向的潜力。利用这些特性提供了巨大的承诺，在改善患者的结果，同时最大限度地减少苛刻的副作用。目前，它是很难快速测量载药分布和药物释放的纳米药物不使用代理和外推。因此，纳米医学领域在药物筛选水平上的可重复性和可靠性较差。研究人员、制造商和监管机构需要了解这些参数，以优化这些高度靶向的纳米治疗药物的剂量和性能。我们最近推出了一种仪器，可以准确测量载药纳米颗粒（包括脂质体和脂质纳米颗粒（LNP））的实时载药分布和释放曲线。我们的多参数传感器提供了一种新颖的高精度方法，用于基于其独特的光学特征快速表征纳米治疗药物，同时独立地测量颗粒的尺寸和折射率。Oxford HighQ的仪器能够测量纳米制剂的多个关键属性，包括：* 每个纳米颗粒的药物质量（作为尺寸的函数）* 实时药物释放曲线 * 外壳/涂层厚度和密度 * 折射率 * 尺寸和多分散性该项目将为医疗保健中使用的脂质纳米颗粒制剂提供参考数据集。该项目的主要目标是提供治疗性纳米颗粒的物理化学性质的正交测量，以证明Oxford HighQ仪器的性能参数，例如其分辨率和检测限，并为纳米颗粒表征提供一系列参考点，支持在先进疗法的QA/QC测试中使用仪器。

Lipid nanoparticles and liposomes offer a revolutionary method of delivering previously infeasible therapeutics in a controlled manner for more effective treatment. These nanomaterials allow for increased penetration into target tissues, altered bioavailability, and have potential for improved targeting within the body. Exploiting these characteristics offers huge promise in terms of improved patient outcomes while minimising harsh side-effects.Currently it is difficult to rapidly measure drug-load distribution and drug-release profiles of nanomedicines without using proxies and extrapolations. As a consequence, the nanomedicine field suffers from poor reproducibility and reliability at the drug-screening level. Understanding of these parameters is required by researchers, manufacturers and regulators to optimise the dosing and performance of these highly-targeted nanotherapeutics.We have recently launched an instrument that can accurately measure real-time drug-load distribution and release profiles of drug-loaded nanoparticles, including liposomes and lipid-nanoparticles (LNPs). Our multiparameter sensors provide a novel and high-precision method for rapid characterisation of nanotherapeutics based on their unique optical signatures, measuring both size and refractive index simultaneously and independently on a particle-by-particle basis. Oxford HighQ's instrument is capable of measuring multiple critical attributes of nanoformulations, including:* Drug mass per nanoparticle (as a function of size)* Real-time drug-release profiles* Shell/coating thickness and density* Refractive index* Size and polydispersityThis project will provide reference datasets for lipid-based nanoparticle formulations used in healthcare. The key objectives of this project are to provide orthogonal measurements of the physicochemical properties of therapeutic nanoparticles in order to demonstrate the performance parameters of Oxford HighQ's instruments, such as its resolution and limit of detection, and to provide a range of reference points for nanoparticle characterisation supporting the use of the instruments in the QA/QC testing of advanced therapies.