Chapter 7: Applying Green Chemistry Principles in Biologics Drug Development

Biologics are an ever-growing sector of the pharmaceutical industry driven predominately by the approval of monoclonal antibody therapies. Biologics are a widely diverse group of compounds including peptides, proteins, antibodies, and some vaccines, which provide an equally wide range of therapeutic benefits. Manufactured by living cells (with the exception of peptides), biologics were generally considered to be environmentally friendly pharmaceuticals. However, biologics drug research, development, and production consume large quantities of water and energy, require the use of caustic acids and bases, significant volumes of single-use plastics and filters, and other raw materials that can be hazardous at the required concentrations for manufacturing. Several initial environmental analyses have been performed for biologics production and underscore the need for incorporating sustainability into the development process. The principles of green chemistry provide an excellent starting point for this endeavor but must be modified to represent the needs of biologics drug development. This chapter provides an overview of the biologics drug production process and how green biologics principles can guide development methodologies and processes to reduce the environmental impact of biologics.