Dégardin Klara, Desponds Anne, Roggo Yves
F. Hoffmann-La Roche Ltd., Bldg 250 Room 3.504.01, Wurmisweg, 4303 Kaiseraugst, Switzerland.
F. Hoffmann-La Roche Ltd., Bldg 250 Room 3.504.01, Wurmisweg, 4303 Kaiseraugst, Switzerland.
Forensic Sci Int. 2017 Sep;278:313-325. doi: 10.1016/j.forsciint.2017.07.012. Epub 2017 Jul 20.
Protein-based medicines, or large molecule medicines, are innovative products used to treat various diseases like hepatitis or cancer. This new generation of molecules are usually expensive, and thus represents an attractive target for the counterfeiters. Due to the complexity of their chemical structure, their analysis for counterfeit detection is more difficult than small molecule medicines. The aim of the article is to demonstrate that Raman spectroscopy and microscopy can be used for the fast analysis of counterfeits of protein-based medicines. Twelve types of medicines, under liquid or lyophilized form, have been analyzed by a Raman spectrometer through their glass packaging and ten of them also by a Raman microscope with drop deposition on a gold plate. The optimization of the acquisition parameters has first been described. Then the identification of the studied products has been presented with the attribution of the protein bands observed on the spectra. Finally the methods were successfully applied to seven counterfeits of these products and their chemical composition identified by spectral analysis. Counterfeits can indeed be detected if the excipient profile differs, if no protein is present, or if the genuine sample has been strongly diluted by the counterfeiters. Raman spectroscopy and microscopy have thus proved efficient for the fast analysis of counterfeits of protein-based medicines.
基于蛋白质的药物，即大分子药物，是用于治疗各种疾病（如肝炎或癌症）的创新产品。这新一代分子通常价格昂贵，因此成为造假者的诱人目标。由于其化学结构复杂，对其进行假冒检测分析比小分子药物更困难。本文的目的是证明拉曼光谱和显微镜可用于快速分析基于蛋白质的药物的假冒品。通过拉曼光谱仪对十二种液体或冻干形式的药物透过其玻璃包装进行了分析，其中十种还通过拉曼显微镜在金板上滴样沉积进行了分析。首先描述了采集参数的优化。然后通过光谱上观察到的蛋白质条带归属展示了所研究产品的鉴定。最后，这些方法成功应用于这些产品的七种假冒品，并通过光谱分析确定了它们的化学成分。如果辅料特征不同、不存在蛋白质或真品样本被造假者大幅稀释，确实可以检测出假冒品。因此，拉曼光谱和显微镜已被证明对快速分析基于蛋白质的药物的假冒品有效。
