用于生物反应器的细胞培养基通常是水溶液，提供细胞最佳生长、产品产量和质量所需的基本营养与条件。培养基成分的细微变化都可能显著影响细胞生长速率和产量。因此，对细胞培养基的鉴定与分析对于保持一致性和优化性能至关重要。

本研究验证了A-TEEM™荧光光谱技术在复杂细胞培养基质量控制中的应用潜力——作为一种快速、可靠的检测手段，该技术能够有效评估不同批次培养基之间的成分差异。通过捕捉芳香族氨基酸及维生素等关键组分的特征光谱指纹，A-TEEM实现了对培养基成分变化的灵敏追踪，同时显著简化了样品前处理流程，避免了传统方法中耗时的分离步骤。

Raman spectroscopy combined with chemometric modeling enables high-throughput, non-destructive quantification of excipient composition in pharmaceutical powder blends.

Raman microscopy combined with high-throughput acquisition enables rapid, non-destructive drug qualification and chemical characterization of pharmaceutical tablets.

3D confocal Raman microscopy enables non-destructive detection and spatial localization of minor crystalline API forms within pharmaceutical extrudates, supporting comprehensive solid-state characterization.

本文展示了粒径相关的拉曼光谱技术（Particle Correlated Raman Spectroscopy, PCRS）作为一种强大手段的优势，它能将粒子特性表征与化学物质鉴定相结合，从而让我们更深入地了解药物在不同药物剂型（喷雾剂、片剂、乳膏剂）中的性能表现。

在过去的5-10年中，分子固体状态因其在药物生产、稳定性和活性方面的关键作用而受到制药业的重视。同时，在专利保护方面，结晶相的定义已与分子组成同等重要。简单的拉曼测量即可区分不同材料，如立体异构体、多晶形现象及伪多形性（由于水合作用）。拉曼仪器在医药产品鉴定方面的潜力正待开发。

活性分子的多态性表征是制药业的重要信息之一，不仅是在原始粉末上，而且在最终形式上。拉曼光谱仍然是这种应用的合适的解决方案。在本文中，我们介绍了一个使用超低频模块通过拉曼光谱进行多态性表征的例子。

拉曼光谱是制药业中一个强大且广泛使用的分析工具，可以在几秒钟内得到辅料和活性药物成分（API），强大的拉曼光谱库使化学鉴定变得容易。

We have measured solutions of lysozyme under conditions known to effect its physical state in order to investigate the potential of Raman spectroscopy as a non-invasive and label-free tool to assess protein formulation stability. Results from this study identified specific Raman signature bands in this protein that can be used to identify individual amino acid residues that are reflect structural changes in proteins.

测量的目的是通过拉曼和FT-IR显微光谱法确定未知成分及其在药片中的各自分散情况。

通过拉曼光谱和光学显微镜的结合，拉曼高光谱成像已被证明是制药领域不可或缺的工具，特别是在研究药物产品中的活性物质和辅料的分布。

为了控制医药产品的配方，表征其活性成份是至关重要的，特别是在颗粒的形态和化学表征方面。在本应用说明中，我们分析了来自一个仿制药和一个创新药的两种配方，以比较其化合物的大小和形状，并根据LabSpec 6的ParticleFinderTM功能对这两种配方进行化学表征。重点对活性化合物进行了分析。

在药物产品的研究中，颗粒特征（计数、大小和化学特征）和化合物分布（大小和空间）是决定产品质量的关键参数，因为这些属性对最终固体剂型的溶解速率（以及生物利用度）有着巨大的影响。监控这些属性对于原材料、加工过程中的中间产物和最终产品至关重要。在本应用报告内容所对应的实验使用了类似于药品混合物的粉末混合物。本文旨在展示将激光衍射技术和拉曼光谱技术联合应用在颗粒物表征方面的显著优点。

Full and detailed characterization of pharmaceutical formulations is required before release of new drugs. When exposed to warm and humid weather over time, ingredients may undergo change in their hydration level, thus affecting the properties and/or efficiency of the drug. Raman spectroscopy, combined to a temperature and humidity controller can mimic such harsh conditions and can be used to monitor the properties of the different ingre-dients and track their modifications induced by environmental changes.

使用含醇凝胶（水醇凝胶）消毒双手已成为日常习惯。与此同时，70%浓度的酒精用于伤口消毒的历史更为悠久。然而，为确保消毒效果，这类产品的酒精浓度不得低于规定阈值，且必须受到严格管控。本应用指南阐述了如何利用拉曼光谱技术在质量控制过程中评估酒精浓度。

拉曼光谱有许多有用的特性，可以在分析药物配方时加以探索和利用：特定的指纹光谱；原位、非接触，最重要的是非破坏性分析；无定形和结晶相的区分；检测晶体的晶格振动；单颗粒表征；快速和强大的原材料分析；自动化和封闭式操作。

制药和晶体样品通常需要详细的表征和分析，以优化样品的稳定性、物理特性以及涉及到活性药物的功效。此外，严格的监管和生产程序要求对固体盐形式的候选药物进行精确的表征，以及环境条件可能产生的影响。不同条件下的水合作用和结构对这种全面的表征非常重要。

由于拉曼光谱技术与光学显微镜技术的结合，拉曼高光谱成像已经成为制药领域不可或缺的工具。本文将介绍我们实验室开发的一些拉曼高光谱成像技术的应用，以证明这项技术的重要性。

Mineral-based sunscreens have gained popularity due to their excellent ability to scatter ultraviolet (UV) rays without causing photo-induced skin irritation from chemical-based sunscreens. Three over-the-counter zine oxide sunscreens were purchased and analyzed using Partica LA-960V2 Laser Diffraction Particle Size Analyzer. A standard 15 mL fraction cell accessory fitted with a magnetic stir bar was chosen for this experiment.

Zeta potential is a key physical parameter that describes surface charge on proteins. Although there has been interest in measuring the zeta potential of proteins for many years, the measurements were often difficult due to a variety of reasons including the “cooking” of proteins on the cell electrodes when using light scattering techniques.

Protein aggregation is an important concern when developing and manufacturing biotherapeutics since these subvisible aggregate particles have been associated with the adverse drug reactions. Protein aggregates may provoke adverse events through an unwanted immune response. And, regardless of mechanism of reaction, subvisible particle contamination has been a concern for manufacturers and regulators.

In this Application Note, we will focus on the importance of monitoring particle size and distribution range throughout two different processing technologies used to improve shelf-life and efficacy of CBD products.

The ViewSizer 3000 enables scientists to visualize and quantify the kinetics of protein aggregation in real-time for biologic therapeutics under a variety of stress conditions including agitation, temperature and the addition of contaminants. The case study featured here validates these capabilities for agitation and temperature stress conditions with the 100 mg/mL mAb A.

A virus particle consists of several parts including the genetic material (DNA or RNA), a protein coat that protects these genes, and in some cases an envelope of lipids that surrounds the protein coat when they are outside a cell. The size of viruses ranges from a few tens to a few hundreds of nm, which is equal to 1/100 to 1/1000 of the cell (a few to a few tens of μm in size) of any other common living organism.

The complexity of viral particles remains one of the biggest hurdles in the development process. In this note, the upstream process of analyzing viral preparations is addressed, as well as the use of multi-laser nanoparticle tracking analysis (NTA) as a cost and time efficient method to measure size, count virus particles, and correlate to infectious titer.

Size matters in vaccine delivery systems. Nanoparticles smaller than 200 nm generally present a greater immunogenic response than micro-particles larger than 1 micron. This rather simple statement is based on the common understanding that particles with sizes resembling the dimensions of viruses are treated like viruses by the body.

外泌体是直径 30-150 纳米的细胞外囊泡，广泛存在于原核和真核生物中，并分布于血液、尿液等多种体液中。其内部携带蛋白质、脂质、核酸等生物活性成分，可参与细胞间通讯，调控免疫应答、组织再生等生理过程，但也可能促进癌症转移和神经退行性疾病发展。由于外泌体成分反映母细胞状态，它在疾病诊断方面具有重要潜力。此外，外泌体可作为药物载体，实现靶向递送，尤其是其穿越血脑屏障的能力，为中枢神经系统疾病治疗提供了新途径。干细胞来源的外泌体还具有促进组织修复的功能。

In this study, we demonstrate the ViewSizer 3000’s capabilities as a next generation NTA based analysis instrument in order to accurately and efficiently measure and characterize extracellular vesicles (EV) via particle size and concentration.