Mass production of full-length IgG monoclonal antibodies from mammalian, yeast, and bacterial hosts

IgG antibodies are tetramers formed by the assembly of two identical heavy chains and two light chains and are critical modulators of various immune responses. This chapter discusses follow-on biosimilar mAbs that are biologically equivalent to the original commercialized ones, summarize current biopharmaceutical processes for the mass production oftherapeutic antibodies using well-established mammalian cell culture systems, and discuss analytical methods for evaluating the physicochemical or functional quality of the follow-on mAb therapeutics. It highlights recently developed breakthrough technologies that employ microbial expression systems that have overcome the limitations of current mammalian cell culture systems and have allowed simple and cheap production of therapeutic mAbs. Yeast is a eukaryote that possesses cellular glycosylation machinery. The fast growth of bacterial cells allows for rapid production of mAbs. Compared with mammalian cell culture systems, development of prokaryotic cell lines requires much less time.