Mechanical characterisation of agarose-based resins is an important factor in ensuring robust chromatographic performance in the manufacture of biopharmaceuticals. Pressure-flow profiles are most commonly used to characterise these properties. There are a number of drawbacks with this method, including the potential need for several re-packs to achieve the desired packing quality, the impact of wall effects on experimental set up and the quantities of chromatography media and buffers required. To address these issues, we have developed a dynamic mechanical analysis (DMA) technique that characterises the mechanical properties of resins based on the viscoelasticity of a 1 ml sample of slurry. This technique was conducted on seven resins with varying degrees of mechanical robustness and the results were compared to pressure-flow test results on the same resins. Results show a strong correlation between the two techniques. The most mechanically robust resin (Capto Q) had a critical velocity 3.3 times higher than the weakest (Sepharose CL-4B), whilst the DMA technique showed Capto Q to have a slurry deformation rate 8.3 times lower than Sepharose CL-4B. To ascertain whether polymer structure is indicative of mechanical strength, scanning electron microscopy images were also used to study the structural properties of each resin. Results indicate that DMA can be used as a small volume, complementary technique for the mechanical characterisation of chromatography media.

琼脂糖基树脂的机械特性是确保生物制药生产中稳定的色谱性能的重要因素。压力-流量曲线最常用于表征这些特性。这种方法有很多缺点，包括可能需要重新包装以达到所需的包装质量，壁效应对实验设置的影响以及所需色谱介质和缓冲液的数量。为了解决这些问题，我们开发了一种动态力学分析（DMA）技术，该技术基于1 ml浆料样品的粘弹性来表征树脂的机械性能。该技术是对7种具有不同机械强度的树脂进行的，并将结果与​​相同树脂上的压力流测试结果进行了比较。结果表明这两种技术之间有很强的相关性。机械强度最高的树脂（Capto Q）的临界速度比最弱的树脂（Sepharose CL-4B）高3.3倍，而DMA技术显示Capto Q的浆料变形率比Sepharose CL-4B低8.3倍。为了确定聚合物结构是否指示机械强度，还使用扫描电子显微镜图像来研究每种树脂的结构性质。结果表明，DMA可以用作色谱介质的机械表征的小体积补充技术。机械强度最高的树脂（Capto Q）的临界速度比最弱的树脂（Sepharose CL-4B）高3.3倍，而DMA技术显示Capto Q的浆料变形率比Sepharose CL-4B低8.3倍。为了确定聚合物结构是否指示机械强度，还使用扫描电子显微镜图像来研究每种树脂的结构性质。结果表明，DMA可以用作色谱介质的机械表征的小体积补充技术。机械强度最高的树脂（Capto Q）的临界速度比最弱的树脂（Sepharose CL-4B）高3.3倍，而DMA技术显示Capto Q的浆料变形率比Sepharose CL-4B低8.3倍。为了确定聚合物结构是否指示机械强度，还使用扫描电子显微镜图像来研究每种树脂的结构性质。结果表明，DMA可以用作色谱介质的机械表征的小体积补充技术。为了确定聚合物结构是否指示机械强度，还使用扫描电子显微镜图像来研究每种树脂的结构性质。结果表明，DMA可以用作色谱介质的机械表征的小体积补充技术。为了确定聚合物结构是否指示机械强度，还使用扫描电子显微镜图像来研究每种树脂的结构性质。结果表明，DMA可以用作色谱介质的机械表征的小体积补充技术。