The Evolving State of Continuous Processing in Pharmaceutical API Manufacturing: A Survey of Pharmaceutical Companies and Contract Manufacturing Organizations

• Published in: Organic process research & development Vol. 22; no. 9; pp. 1143 - 1166
• Main Authors: McWilliams, J. Christopher, Allian, Ayman D, Opalka, Suzanne M, May, Scott A, Journet, Michel, Braden, Timothy M
• Format: Journal Article
• Language: English
• Published: American Chemical Society 21-09-2018
• Subjects: flow process; pharmaceutical; continuous process; outsourcing; survey; active pharmaceutical ingredient; contract research organization; contract manufacturing organization; unit operations; flow chemistry
• ISSN: 1083-6160; 1520-586X
• DOI: 10.1021/acs.oprd.8b00160

This manuscript provides the results of an in-depth survey assessment of the capabilities, experience, and perspectives on continuous processing in the pharmaceutical sector, with respondents from both pharmaceutical companies and Contract Manufacturing Organizations (CMOs). The survey includes staffing (personnel), chemistry, reaction platforms, postreaction processing, analytical, regulatory, and factors that influence the adoption of continuous manufacturing. The results of the survey demonstrate that the industry has been increasing, and will continue to increase, the portion of total manufacturing executed as continuous processes with a decrease in batch processing. In general, most of the experience with continuous processing on scale have been enabling reaction chemistry, while postprocessing and analytical remain in the very early stages of development and implementation.