尼妥珠单抗原液生产车间工艺设计

Design of Nituzumab Antigen Solution Production WorkshopAbstractimotuzumab (Nimotuzumab)is an IgGl humanized monoclonal antibodythat specifically binds to the epitope of the extracellular domain of EGFR[1],preventing its activation.Clinically,it is mainly used incombination with radiotherapy for the treatment of stage III IVnasopharyngeal carcinoma with positive expression of epidermal growthfactor receptor (EGFR).According to the existing amino acid sequence of nimotuzumab,theheavy chain and light chain genes of the monoclonal antibody ofnimotuzumab were artificially synthesized,and the pSV2-gpt plasmid ofthe heavy chain of nimotuzumab and the pSV-hyg plasmid encoding the lightchain were transferred into CHO host cells to obtain engineered cells thatcan stably express Nitozol clone antibodies.Using cell perfusion culturetechnology,through cell expansion culture and fermentative expressionculture,the monoclonal antibody of Nitozol is produced in CHO cells ofmammalian cell expression system,which is then purified usingrecombinant protein A,virus inactivation and nanofiltration membranefiltration.The purification process within the purification,and thenaseptically fill the production process of the monoclonal antibody stocksolution.According to the characteristics of monoclonal antibody productionprocess,follow the requirements of GMP and relevant national designspecifications,according to the production process of Nitrozinemonoclonal antibody,design the production workshop of Nitrozinemonoclonal antigen solution that meets GMP requirements.Keywords:Nitozumab,perfusion culture process,workshop design