Requirements for Fully Integrated Offerings in a HPAPI and Cytotoxic Environment

The development of drug products based on potent compounds can be challenging, plus complications with the interface between operations in drug substance and drug product handling can result in increased program complexity and cost. This presentation describes best practices and infrastructure requirements that facilitate accelerated timelines to clinic and market. Topics include containment requirements, the impact of integrated service offerings on expansion strategies, and a case study of the development and commercialization of a highly potent drug substance. To learn more about this presentation, please view the summary.