非人类的哺乳动物细胞系或动物血清来源的糖蛋白类生物技术药物常以一定比例（或高或低）携带Neu5Gc型唾液酸修饰。而Neu5Gc型唾液酸在人体内具有免疫原性，可引发人体产生Neu5Gc抗体，这可能导致含有Neu5Gc修饰的糖蛋白类药物在体内被中和及快速清除。因此，降低重组糖蛋白中Neu5Gc的水平，是含唾液酸修饰的糖蛋白药物的关键质量属性（CQA）。本项目拟利用分子印迹技术，以Neu5Gc型唾液酸为模板，固相合成可特异识别Neu5Gc的磁性分子印迹纳米粒子；通过磁性纳米粒子对Neu5Gc的识别，从而识别并分离净化含有Neu5Gc修饰的糖蛋白药物，达到降低总药物中Neu5Gc水平的目的。本项目旨在分离净化携带Neu5Gc型唾液酸修饰的糖蛋白药物，为提高唾液酸修饰的糖蛋白类生物技术药物的药品质量开辟一条新的途径。相关研究国内外均未见报道，也未见相关专利申请授权。

N-glycolylneuraminic acid (Neu5Gc), an immunogenic nonhuman dietary sialic acid from mammalian food, has aroused increasing interests and attention during the past decade for its potentially hazardous to human health. Recombinant glycoprotein therapeutics produced in nonhuman mammalian cell lines and/or with animal serum are often modified with Neu5Gc. This documented contamination has generally been ignored in drug development because healthy individuals were not thought to react to Neu5Gc. However, recent findings indicate that all humans have Neu5Gc-specific antibodies, sometimes at high levels. Circulating anti-Neu5Gc antibodies can promote neutralization and clearance of biotherapeutic glycoproteins carring Neu5Gc. Reduction or elimination of this sialic acid in recombinant proteins, as being one of the critical quality attributes (CQA) of biotherapeutic glycoproteins, is highly desirable. In this project, we try to synthesis molecularly imprinted nanoparticles using molecular imprinting technique for specific recognition and adsorption of Neu5Gc. By utilizing such molecularly imprinted nanoparticles, we try to identify and separate biotherapeutic glycoproteins carring Neu5Gc, in order to reduce the level of Neu5Gc in total biotherapeutic glycoproteins. The aim of the project is to open up a new way for separation and clearance of biotherapeutic glycoproteins with Neu5Gccontamination and also set up a new method for improving the quality of sialic acid modified biotherapeutic glycoproteins. Related researches and patents haven't been published so far.