Continuous manufacturing has generated buzz in the pharma industry for years. Some large pharmaceutical manufacturers have even piloted continuous manufacturing (CM) under the U.S. Food and Drug Administration’s Emerging Technology Program (ETP).
But beyond the small number of companies testing the waters on CM, the industry has yet to fully embrace this advanced technology as a replacement for the tried-and-true decades-old batch processing of pharmaceutical products. Aside from the regulatory risks of implementing and validating a new process in a pharma facility, companies may also be squeamish about making large investments in technologies that have yet to prove their worth across the industry. CM sounds good in theory — but is it really the best bet for a company’s bottom line?
This year, I spearheaded a research effort at the University of Maryland’s Robert H. Smith School of Business to answer that question. Using a simulation-type of analysis comparing the net present value (NPV) of investing in CM versus batch technology in the U.S. or abroad, the study gathered hard data to determine whether or not CM provides more economic benefits over batch for oral solid dose (OSD) products made in new facilities.
