- The FDA wants drug manufacturers to transition away from its standard manufacturing practices to a speedier technique known as continuous manufacturing. In a blog post this week, FDA Deputy Director Lawrence Yu argued continuous manufacturing offered a safer and more reliable choice than "batch" technology.
- Yu noted the agency has begun to see more companies building continuous manufacturing into their production processes—something which the industry has been slow to do.
- Last week, the FDA approved the first switch from batch to continuous manufacturing, giving the green light to Janssen for production of its HIV-1 drug Prezista.
Batch processing, which the industry has relied on for more than a century, produces the finished drug in a series of successive steps. While tried and true, it introduces delays and inefficiencies into the process.
Continuous manufacturing on the other hand, feeds raw materials through a continuous, nonstop process. This boosts the speed of the production process, potentially by a significant amount. Yu noted some processes which would take one month under batch processing can be competed in a day with continuous manufacturing.
By reducing the amount of human intervention (where batches are taken from one step in the process to the next), the FDA seems to think continuous manufacturing can be safer too.
But pharma companies have been slow to adopt the new method. Much of the industry and regulatory apparatus is built around batch processing and it would be expensive to overhaul. Yet, once a system is switched over, there could be room for substantial savings in the costs associated with producing any given unit of drugs. One estimate from the National Science and Technology Council puts variable cost savings as high as 40% to 50% compared to batching.
There are some early adopters. Vertex has been using continuous manufacturing for its cystic fibrosis drug Orkambi since July 2015, according to the FDA. Just last week, Elil Lilly announced it would invest €35 million in building a continuous API facility in Ireland for its late-stage pipeline.
And the FDA's approval of Janssen's switchover last week should help pave the way for other companies to do the same. That's what the regulator is hoping for, at least.
"FDA will continue our efforts to encourage the advancement of continuous manufacturing as one of a variety of ways to enhance the quality of the medications used by the American public," Yu said.