LASIR CNRS UMR 8516, Université de Lille, Sciences et Technologies, 59655 Villeneuve d'Ascq Cedex, France.
Sanofi Pasteur, 1541 Avenue Marcel Mérieux, 69280 Marcy-l'Étoile, France.
Anal Chim Acta. 2015 Sep 10;892:148-52. doi: 10.1016/j.aca.2015.08.050. Epub 2015 Sep 3.
The Food and Drug Administration's (FDA) process analytical technology (PAT) framework has been initiated to encourage drug manufacturers to develop innovative techniques in order to better understand their processes and institute high level quality control which allows action at any point in the manufacturing process. While Raman spectroscopy and chemometrics have been successfully used to predict concentration of conventional metabolites in cell cultures, it is really not the case for active substances. Thus, we propose, for the first time, an in-line and real-time prediction of recombinant antibody titer using an immersion probe link to a spectrometer without the tacking of samples. A good robustness of the method is observed on different culture batches and the contamination risk is drastically reduced which is an important issue in biotechnology manufacturing processes.
美国食品和药物管理局（FDA）的过程分析技术（PAT）框架已经启动，旨在鼓励制药商开发创新技术，以便更好地了解其工艺，并采用高级别的质量控制，从而可以在制造过程中的任何点采取行动。虽然拉曼光谱和化学计量学已成功用于预测细胞培养物中常规代谢物的浓度，但对于活性物质却并非如此。因此，我们首次提出了一种使用浸入式探头与光谱仪连接的在线实时预测重组抗体滴度的方法，而无需跟踪样品。该方法在不同的培养批次中表现出良好的稳健性，并且大大降低了污染风险，这在生物技术制造过程中是一个重要问题。
