开发在2个月内制造100,000,000剂量的应急医药(如疫苗或单克隆抗体)的产品鉴定系统
Develop Systems for Manufacturing 100,000,000 Doses of an Emergency Phamaceutical
关键词:疫苗;单克隆抗体;应急医药
摘 要:Based on the data we have generated in the first six months of the project, we believe we have exceeded the milestones for this project. Initial genetic constructs for the Herceptin IgG human antibody were made and transformed into Trichoderma reesei. These strains were screened for antibody production in shake flasks. A few of the strains were tested at the 14-liter fermentation scale. We have been able to produce over 3 g/L of full length IgG as determined by ELISA. We have produced 0.7 g/L of a non-glycosylated variant of the Herceptin IgG human antibody at 14L scale. A number of different genetic constructs have also been made to optimize the Kex2 cleavage site. Our best constructs show greater than 90cleavage of the fusion proteins to products. Our data indicate that Trichoderma reesei is an efficient host for the production of antibodies