Pharmaceutical Monoclonal Antibodies: Production, Guidelines to Cell Engineering and Applications

Monoclonal antibodies (mAb or moAb) are monospecific antibodies which are made from identical immune cells that are all clones of a unique parent cell. Monoclonal antibodies have monovalent affinity, in that they bind to the same epitope 1. Monoclonal antibodies (mAbs) are currently used for many diagnostic and therapeutic applications. Advances in the development of mAb-producing cell lines are being made, particularly regarding expression vector design and methods used for transfection, with the intent to create a reproducible methodology [10]. Selection of the most suitable clones is also a critical step that can be improved, by including variables other than the expression level, which is still the common practice. Furthermore, strategies of cell engineering, although still mostly based on trial-and-error experimentation and not in standard protocols, hold great interest to improve cell growth and productivity, as well as product quality in the future. Improvements of the initial steps of the production process would not only result in cells with higher expression ability, but would also speed-up the process development. In this review article production, regulatory guidelines to cell engineering and applications of monoclonal antibodies are discussed.