(123b) Development of Safe and Efficient Potent Compound Handling Practices for Development Labs and Kilo Labs

Safe handling practices for potent and highly potent compounds are essential in order to develop, manufacture, and commercialize new medicines without compromising worker safety. The specific strategy which may involve engineering controls, specialized equipment, and handling practices to protect workers from exposure can have a major impact on the cost, flexibility, and capabilities of lab and pilot plant facilities. Establishing a robust potent compound handling strategy for development labs, kilo labs, and pilot plants that are intended to support chemical process development and manufacturing for a wide variety of processes and unit operations can be challenging. This talk will present the approach used to establish safe and flexible potent handling practices and engineering controls for development lab and for kilo lab operations for small molecule active pharmaceutical ingredients. An existing development lab was retrofitted and a new kilo lab was designed to be suitable for highly potent compounds (100 ng/m³ OEL). The selections of engineering controls were made to limit exposure risks while enabling speed in development, and the selected technologies and practices were validated through extensive surrogate testing activities. The newly designed kilo lab leveraged a combination of custom-designed fixed- and flexible isolator technologies. The developed handling practices enabled the safe and rapid development of highly potent medicines intended to address significant unmet medical need.