Manufacturing and Bioprocessing – Chemical
2019 PharmSci 360
As more and more experience accumulated on the use of continuous manufacturing of drug products, the value of PAT has been well demonstrated from development to commercialization stage. In early development, the benefit of agile/lean PAT approaches has been proven valuable on improving process understanding and preparing for its readiness for GMP decision making. In late stage, the value of PAT is manifested on its critical roles played in the control strategy to assure product quality. The common use of PAT methods often ranges from monitoring, IPC, to RTRt. The presentation aims to survey the industrial practice on the different roles of PAT methods played in the control strategy, discussing the comprehensive considerations and challenges from technical, regulatory and quality aspects.