Workshop Session Three: Phase Appropriate Development from a GMP Perspective

In response to the competitive landscape, unmet medical needs and increased patient demand, pharmaceutical companies have taken phase appropriate GMP approaches to accelerate drug development to market. In addition, increased interactions between regulatory agencies and industry also allowed for clarity and acceptability of these expedited approaches. This session focuses on industry and regulatory perspectives of phase appropriate GMP considerations for process and analytical development and validation, including considerations for different modalities (e.g. antibody-drug conjugates, vaccines, cell/gene therapies). Furthermore, the session will also cover innovative approaches such as setting of phase appropriate specifications, use of pools of clones for toxicological studies, clearance of process- and product-related impurities, phase appropriate raw materials testing, and inspection and commercial readiness.