However, improvement of in vivo efficacy of therapeutic antibodies continues to be a challenge. Recombinant antibodies are molecular-targeted therapeutic agents, and these agents represent a major new class of drugs. More than 200 monoclonal antibodies are in clinical trials, and this number is predicted to increase to around 250 by 2010. The worldwide revenue of therapeutic antibodies has reached $20 billion in 2007 and eight therapeutic antibodies are “blockbusters” with more than $1 billion annual sales. 1 – 4 Currently 22 therapeutic monoclonal antibodies are approved by the US Food and Drug Administration (FDA). The clinical successes of recombinant humanized therapeutic antibodies have included improvement of overall survival and time to disease progression in the treatment of human malignancies, such as breast, colon and hematological cancer. In this article, we review the current technologies for production of therapeutic antibodies with control of fucosylation of the Fc N-glycans. Thus, an industrially applicable antibody production process that provides consistent yields of fully non-fucosylated antibody therapeutics with fixed quality has become a key goal in the successful development of next-generation therapeutic agents. ![]() Clinical trials using therapeutic antibodies fully lacking core fucose residue in the Fc oligosaccharides are currently underway, and their remarkable physiological activities in humans in vivo have attracted attention as next-generation therapeutic antibody approaches with improved efficacy. However, it is still very important to optimize and maximize the clinical efficacy of therapeutic antibodies, in part to help lower the cost of therapeutic antibodies by potentially reducing the dose or the duration of treatment. Recombinant antibodies are molecular-targeted therapeutic agents and represent a major new class of drugs. The clinical success of therapeutic antibodies is demonstrated by the number of antibody therapeutics that have been brought to market and the increasing number of therapeutic antibodies in development.
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