PDF(Pubmed)
Abstract：
Personalized dosages of monoclonal antibodies are being used more regularly to treat various diseases, rendering their quantitation more essential than ever for the right dose administration to the patients. A promising alternative, which overcomes the obstacles of the well-established chromatographic techniques regarding the quantification of biopharmaceuticals, is Raman spectroscopy. This study aimed to develop and validate a novel analytical method for the quantitation of bevacizumab in solutions via Raman spectroscopy. For this purpose, a droplet of the solution was left to dry on a highly reflective carrier and a home-made apparatus was employed for rotation of the sample. Hence, each recorded Raman spectrum was the average of the signal acquired simultaneously from multiple points on a circular circumference. The method was validated, and the detection limit of the antibody was found to be 1.06 mg/mL. Bevacizumab was found to be highly distributed at the formed coffee ring of the dried droplet, though this was a function of solution concentration. Finally, Raman spectra at different distances on the coffee ring were obtained from the four quarters. The lowest bevacizumab detection limit was found at a distance of 75 μm from the external side of the coffee ring and it was determined to be equal to 0.53 mg/mL.
摘要：
单克隆抗体的个性化剂量被更经常地用于治疗各种疾病，使他们的定量比以往任何时候都更重要的正确剂量给药的患者。一个有希望的选择，它克服了关于生物制药定量的成熟色谱技术的障碍，是拉曼光谱。本研究旨在开发和验证一种通过拉曼光谱定量溶液中贝伐单抗的新分析方法。为此,将溶液的液滴留在高反射载体上干燥,并使用自制的设备旋转样品。因此，每个记录的拉曼光谱是从圆形圆周上的多个点同时获得的信号的平均值.对该方法进行了验证,抗体的检测限为1.06mg/mL。发现贝伐单抗高度分布在干燥液滴的形成的咖啡环上，虽然这是溶液浓度的函数。最后,从四个季度获得咖啡环上不同距离处的拉曼光谱。在距咖啡环的外侧75μm的距离处发现最低贝伐单抗检测极限,并且其被确定为等于0.53mg/mL。
