Addressing barriers in implementing pharmaceutical continuous manufacturing – Key concepts & challenges in pharmaceutical continuous manufacturing
GABRIELA GRASA MANNINO
U.S. Pharmacopeia, Rockville, MD, USA
Abstract
Pharmaceutical continuous manufacturing (PCM) can reduce production time, decrease labor costs, and optimize process flow and the supply chain. Although some industry leaders have already invested in PCM, its widespread implementation has yet to be achieved. Major challenges to adoption include knowledge gaps in multiple aspects of quality control, workforce capacity limitations with a lack of PCM expertise, logistics, uncertainty around regulations, start-up costs, industry economic dynamics including significant excess batch manufacturing capacity for generic medicines, and low prices for generics that can impede capital investment in PCM. To address these issues, it is necessary to ramp up education on the broader concepts, equip the workforce with the necessary skills, partner with organizations with adequate resources to ascertain quality control, alleviate uncertainty around regulatory review, and facilitate exploration of where PCM may be most impactful in terms of return on investment.
