Although the global market of mAbs is progressing well, there were some crucial challenges concerning mAb manufacturing such as the process robustness, product reproducibility, product yield, and characterization. There are 31 new mAbs and 10 biosimilars that had been introduced to the market since 2013, which made the global market in a total of 51 mAbs and 11 biosimilars at the end of 2017. According to Biopharma trend survey March 2019, the major portion among biopharma products in the product pipeline is monoclonal antibodies ( Fig. Attempts were also made to improve the efficiency of antibodies either by the production of chimeric monoclonal antibodies which contain murine variable regions and human Fc IgG component or by producing fully human monoclonal antibodies. The commercial development of monoclonal antibody for therapeutic development was established inthe early 1980s and the first approved monoclonal antibody was OKT3 for the prevention of kidney transplant rejection in 1986. The production of safe, efficacious and affordable monoclonal antibodies in surplus quantities warrants advanced process strategies to overcome the disadvantages of conventional methods. The requirement of monoclonal antibodies (mAbs) as therapeutic agents and also in diagnostic applications is rising continually after the successful Nobel Prize-winning discovery of hybridoma technology by Georges Kohler and Cesar Milstein in 1975. These developments in high-density cell culture systems have led to the monoclonal antibody production in an economically favourable manner and made monoclonal antibodies one of the dominant therapeutic and diagnostic proteins in biopharmaceutical industry. Packed bed systems and disposable wave bioreactors have also been introduced for high cell density culture. As an alternative to hollow fiber reactors, a novel disposable bioreactor has been developed, which consists of a polymer-based supermacroporous material, cryogel, as a matrix for cell growth. Among the reactors, hollow fiber bioreactors contribute to a major part of high-density cell culture as they can provide a tremendous amount of surface area in a small volume for cell growth. This review describes recent trends in high-density cell culture systems established for monoclonal antibody production that are excellent methods to scale up from the lab-scale cell culture. To produce these proteins in sufficient quantities for commercial use, it is necessary to raise the output by scaling up the production processes. Monoclonal antibodies are widely used as diagnostic reagents and for therapeutic purposes, and their demand is increasing extensively.
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