Review on monoclonal antibodies – Manufacturing aspects, tactics, and future prospects

Abstract

Since 1940, the researches related to antibodies have acknowledged beneficial understanding of the antibody formation,
its structure and diversity but the experimentation in Hybridoma technology in 1975 instigated the interest in clinical
application of monoclonal antibodies. Monoclonal antibodies are emerging pharmaceutical products, used in the treatment
of cancer, allergies, auto-immune disease, and inflammation. Although a potent biologic, it has obstacles in regulatory
approval process and its approval has been hindered due to a lack of manufacturing consistency or the implementation of
manufacturing improvements late in the product development process. The major drawback is not being able to preserve
the efficacy, safety, and promote industrialization of the product. This review predominantly emphasizes the complications
that underlie in the development of monoclonal antibodies such as its instabilities, determines conceptual actions such
as approaches for stabilization, and explains the problems and future prospects of monoclonal antibody therapy and
alternative form of antibody delivery. The development of stable formulations and effective clinical implementation of
monoclonal antibodies can be used for targeted drug delivery methods in the near future.