Editor’s (re)View: It’s time for pharma to make continuous manufacturing a reality
Continuous manufacturing — the uninterrupted flow of materials and consistent production of finished products — offers a simple proposition. By producing in a continuous flow, manufacturers can potentially meet demand faster and with fewer resources, while reducing costs and boosting supply chain resilience.
Although the concept has been around for decades, the pharmaceutical industry has been slow to adopt continuous manufacturing. However, the tide appears to be turning. In a featured article this week, Flow state: The evolving shape of continuous manufacturing, we took a look at the process as an alternative to traditional batch manufacturing.
In response to the article, a reader wrote that the “practice of producing products continuously has been taught and been around for the last 75 years.” While continuous manufacturing offers the pharmaceutical industry a myriad of benefits, “the Village has to get involved from inception,” according to the reader, who lamented that the problem is the “Pharma GODs don’t like to learn as they know it all.”
Yet, when it comes to preaching the benefits of continuous manufacturing, companies like Continuus Pharmaceuticals, Enzene Biosciences, ReciBioPharm, and Thermo Fisher Scientific are leading the charge.
Bhakti Halkude, associate director and head of drug product at Continuus Pharmaceuticals, argued in this week’s article that what is needed in the pharmaceutical industry when it comes to continuous manufacturing is a major shift — both ideologically and technologically, driven by the need for greater efficiency, cost reduction, and improved product quality.
With recent calls by the Trump administration and stakeholders for reshoring drug production, continuous manufacturing could also be a solution for enhancing America’s supply chain resilience. In testimony before Congress in 2019, Janet Woodcock, then-director of the FDA’s Center for Drug Evaluation and Research, told lawmakers that continuous manufacturing “could enable U.S.-based pharmaceutical manufacturing to regain its competitiveness with China and other foreign countries.”
Last week, U.S. Pharmacopeia CEO Ronald Piervincenzi testified before a congressional hearing that continuous manufacturing and flow chemistry are key to modernizing, localizing, and stabilizing domestic production.
“These alternate manufacturing processes will help to mitigate identified supply chain risks, and this work can help bring quality-assured products to market more efficiently, strengthen domestic manufacturing capabilities, and build national security,” according to Piervincenzi.
At the same time, technologies such as artificial intelligence, automation, and real-time monitoring systems are making continuous manufacturing more practical and effective. For a host of reasons, including environmental benefits such as reduced waste, lower energy consumption, and fewer emissions, the time has come for the pharma industry to make continuous manufacturing a reality. But will it?
The good news, according to a recent CRB Horizons: Life Sciences survey, is that 75% of respondents are using or plan to use continuous technologies almost exclusively within the next five years. The bad news: While continuous technologies have been adopted for individual processes, CRB found the implementation of end-to-end continuous manufacturing in the pharma industry remains elusive.
