目前公司正開發國際非專利藥品名Tocilizumab的生物相似藥，其為治療抗類風溼性關節炎 (RA) 之藥物。C反應蛋白(CRP)在臨床上用作評估RA中IL-6活性和炎症的生物指標，IL-6與IL-6受體(IL-6R)結合後，通過激活Janus激?信號 (JAK) 的通路，JAK會激活轉錄激活蛋白(STAT)的磷酸化和活性以調節細胞內的機能，最後促進CRP的合成。而Tocilizumab是IL-6R的單株抗體IgG 1，能夠與IL-6R結合並阻斷後續的發炎反應，其結合效價是判斷藥物活性的重要指標。
傳統的效價檢驗方法是ELISA為主，本研究是透過SPR技術開發檢驗方法以分析Tocilizumab與IL-6R間的關聯並建立快速方便又省力的檢測方法去檢驗Tocilizumab之效價，作為產品批次放行時的檢測項目。
At present, the company is developing a biosimilar drug of the international generic drug name Tocilizumab, which is a drug for treating rheumatoid arthritis (RA). C-reactive protein (CRP) is clinically used as a biomarker for assessing IL-6 activity and inflammation in RA. IL-6 binds to IL-6 receptor (IL-6R) and activates the Janus kinase signal (JAK). The pathway, JAK, activates the phosphorylation and activity of transcriptional activator (STAT) to regulate cellular functions, finally promote the synthesis of CRP. Tocilizumab, a monoclonal antibody IgG 1 of IL-6R, binds to IL-6R and blocks subsequent inflammatory responses, it’s combined potency is an important indicator for judging drug activity
SPR is an instrument introduced by many pharmaceutical companies in recent years. It is favored by many people in the industry because it is fast, labor-saving and can be operated without the need of quite a professional.
The traditional potency test method is ELISA , this study is to develop the test method by SPR technology to analyze the relationship between Tocilizumab and IL-6R and establish a quick and convenient and labor-saving test method to test the titer of Tocilizumab as a test item when the product batch is released.
