Emerging Biopharmaceutical Technologies and Trends

The biopharmaceutical industry is driven to innovate by the discovery of new therapeutics and modalities, as well as shifts in regulatory guidelines, market forces, and intellectual property law. Most recently, gene therapy, drug conjugates, chimeric antigen receptor (CAR)-T therapies, and a variety of fusion proteins have demanded effective manufacturing antibody methods that do not conform to established platforms. In addition, patent expiration on historic blockbuster drugs has driven a gold rush for biosimilars, which will also require more efficient and inexpensive production methods in a newly competitive market. At the same time, the need for process mobility, flexibility, and miniaturization has increased, with the goal of serving new patient populations under ambitious business growth models. Thus, it is useful to examine the new technologies that are being developed to address these needs. In this chapter, we will review several emerging trends and technologies, with some attention to the philosophical and economic drivers for their development.