生物技术药物免疫原性检测中改善药物耐受研究进展

随着大量生物技术药物的研发,生物技术药物的评价越来越受到重视.与传统小分子药物不同,生物技术药物在体内产生的抗药抗体(ADA)可能会中和药物的活性,造成在非临床和临床研究中观察到的效应并非药物真正的药理和毒性反应,因此需要对药物的免疫原性进行评价.通过检测ADA可评价药物的免疫原性.检测ADA的主要干扰物质为药物本身....

Research progress in improvement of drug tolerance in immunogenicity assay of biotechnology drugs

With the development of many biotechnology drugs,the evaluation of biotechnology drugs has received more attention.Unlike traditional small molecule drugs,biotechnological drugs can produce anti-drug antibodies(ADAs)in the body that may neutralize the activity of drugs so that the effects observed in non-clinical and clinical studies are not the true pharmacological and toxical effects of drugs,hence the need to evaluate the immunogenicity of drugs,possibly by detecting ADAs.The main interfering substances detected by ADAs are usually derived from the drug itself.The most widely used bridging ELISA is currently unable to detect the drug-ADA complex,which leads to the false negative results in the test and affects the accuracy of the results.Drug tolerance is an important indicator in the validation of immunogenicity assay.It is important to minimize the interference of free drugs and objectively reflect the level of ADAs in the body.Therefore,proper sample preparation is the key to accurate measurement results.The pretreatment methods that have been reported include solutionELISA,acid treatment,precipitation and acid dissociation,bead extraction and acid dissociation,beadextraction and heat-dissociation.They can help reduce drug interference and improve drug tolerance.