Monoclonal Antibodies as Promising Therapeutic Agents in the Pharmaceutical Industry and Their Current Challenges.

Abstract

Monoclonal antibody discovery and their use as therapeutic agents have made a revolutionary transformation in the research focus of the pharmaceutical industry which reflected to market growth with their promising profile for considerably severe diseases which are lacking in a complete treatment such as cancer and autoimmune disorders. However, their biochemical aspects bring various complexity and challenges in the development and use. This study evaluates the impact that monoclonal antibody therapeutics have made on the pharmaceutical industry, identifies the success in the generation of different monoclonal antibody formats over time, finds out the current bottlenecks within the development and therapeutic use of monoclonal antibodies, and assesses their potential as therapeutic agents for currently untreatable diseases, with a special emphasis on their promising implementation into COVID-19. The study comprises qualitative and quantitative approach and was carried out with a group of 98 professionals that consisted of scientists, medical doctors, regulatory professionals, pharmaceutical/biotechnology professionals. Findings show that the most challenging factor in the development of monoclonal antibody therapeutics is the drug design and formulation, while high costs was identified as the most challenging factor for their use. Even though the bottlenecks in the development and use of monoclonal antibodies, challenges are considered manageable in the close future as a consequence of the growing interest in improving monoclonal antibodies, and global focus for their use against COVID- 19, as well as patent expirations which will lead to biosimilar alternatives.