重组抗EGFR人鼠嵌合单克隆抗体原液生产车间工艺设计

北京理工大学珠海学院2020届本科生毕业设计Process design of workshop for production of recombinant humanmouse chimeric monoclonal antibody against EGFRAbstractToday,with the development of single drug resistant capacity of the single drug resistantfar cannot satisfy the demand of the market,and because by hybridoma technologypreparation of monoclonal antibody is the source of the rat,apply to the human bodyinevitably cause anti mouse antibody (HAMA)response,so will be the source of the ratantibodies variable area with constant region joining together to form a chimeric antibody orwill be decided the mouse antibody variable area complementary area(CDR)and antibody ofcomplementary decision of the district swap humanized antibody,basically settled theproblem of antibody drugs of different source sex.At present,there are three kinds of anti-egfr monoclonal antibodies on the market athome and abroad.Compared with other chemotherapeutic drugs,they have clear targets,significant efficacy and low toxic and side effects,and have achieved good clinical efficacy.The product was approved for domestic market in 2009.This design mainly aims at theworkshop production of cetuximab to carry on the design,the main product is divided intoanimal cells fermentation culture and downstream purification two parts,choose expressrecombinant EGFR resistant human mouse chimeric monoclonal antibody of CHO cells as ahost cell,suspension culture and cultivate in partial flow and feeding way,downstream usingaffinity chromatography,ion exchange chromatography for purification of product.Theworkshop consists of several steps:seed recovery,seed expansion culture,fermentation inferment tank and protein purification.According to the production process and the principleof zoning,seeds,fermentation,harvest and purification are divided into several mainproduction areas.Key words:Animal cell culture;Purification,;Material balance;Workshop design