INTRODUCTION TO BIOLOGICAL ASSAYS

Biological assays, or bioassays, are indispensable to the pharmaceutical and biologics industry, since they play an essential role throughout all stages, from discovery to manufacturing of drug substances and drug products to stability assessments. During the research phase, bioassays are developed to help design or identify a biological product by matching its structure with its function as defined by the target mechanism of action. During development, bioassays are used to support clinical trials as well as process and formulation development. In the process of manufacturing, bioassays are used to help ensure reliable and high-quality drug products and drug substances. This chapter aims to describe bioassays for biotherapeutics, vaccines, and cell and gene therapies.