BioPharma Drug Development Workflow and Techniques
Drug development is a long and complex process that starts with discovery and, if successful, ends with government approval for marketing. Each step in the drug development process, outlined below, has specific goals with the aim of down-selecting appropriate hits and candidates to an approved drug substance. Here, we discuss the relevant objectives and techniques used in each stage of antibody drug development. Discovery The discovery phase is broken down into early and late-stage discovery. The primary goal of the discovery stages is to remove any sequence with undesired performance considering both chemical instabilities and target binding. Discovery will start with a large panel of antibodies that may range from hundreds to thousands and be reduced to a pool in the tens. To reduce the panel, in silico screening is commonly used as a primary tool because sample availability is very scarce at this stage. In silico screening uses computer simulations or virtual screening tools t...