More and more drugmakers are giving continuous manufacturing a try, seeing it as the future in small molecule drug production, in part, because the plants for the process are much smaller than those for batch processing. Now, scientists at MIT have a prototype of a continuous manufacturing device so small it might be used by pharmacies to produce their own generic drugs.
The work for the unit is being funded by the Defense Department, which sees its potential to be put into field hospitals or dropped into combat zones to produce some drugs, MIT scientists told NPR. But there could be lots of other uses for a unit the size of a refrigerator that can produce 1,000 pills in 24 hours, say, pharmacies or hospitals that want to produce their own drugs.
Allan Myerson, an MIT professor of chemical engineering, says it could eventually be an option for anyone. "We're giving them an alternative to traditional plants and we're reducing the time it takes to manufacture a drug," he says.
The equipment has yet to be approved by the FDA and there are lots of questions about impinging on intellectual approval and oversight if there are thousands of these around the world churning out meds. MIT, where much of the work for continuous processing has been done, is instead focused on reducing the size of the unit even further.
But the unit does offer possibilities for the industry at a time when more companies are buying into the benefits of continuous manufacturing, in which ingredients are continuously fed into production units that integrate weighing, milling, blending, compression and other processes into a single line. The process requires less production space, so it costs much less and produces far less waste.
The FDA, which has approved several continuous manufacturing operations already, is pushing the industry to embrace the technology, seeing it as one way to improve drug-making quality by reducing the chances for human error.
The agency has approved a $30 million, 4,000-square-foot continuous manufacturing facility in Boston built by Vertex ($VRTX) to produce its new cystic fibrosis drug, Orkambi. And in April it gave Johnson & Johnson’s ($JNJ) Janssen drug unit approval to switch from batch processing to continuous production for its HIV drug Prezista on a line at its plant in Gurabo, Puerto Rico. J&J has said it plans to eventually produce 70% of its high-volume products through continuous manufacturing.
Other drugmakers including Eli Lilly ($LLY) and GlaxoSmithKline ($GSK) are building continuous manufacturing facilities.
- here’s the NPR piece
FDA urges companies to get on board with continuous manufacturing
Lilly commits to continuous manufacturing with Ireland plant
Vertex, J&J, GSK, Novartis all working on continuous manufacturing facilities