Regulatory considerations regarding quality aspects of monoclonal antibodies

In the past two decades, more than 20 therapeutic monoclonal antibodies (MAbs) targeting a range of antigens (and working through a variety of mechanisms) have been approved for treatment of serious diseases. First to be approved were murine antibodies, followed by humanized molecules with superior efficacy, safety, and tolerance. Most of the licensed MAbs have been made by the hybridoma method and expressed in cell culture.(2, 3) This review describes the next generation of MAbs, taking next generation antibodies into account, and suggests considering international regulatory guidelines for qualifying and characterizing monoclonal-antibody-producing source cells at different phases of development. In addition, in vivo and in vitro manufacture of MAbs is outlined. Adhering to the guidelines ensures a finished product of consistent pharmaceutical quality.