Moving away from the design of massive pharmaceutical plants, MIT researchers developed a small, transportable machine
that can formulate and dispense drugs on the go, and on demand. Roughly the size of a household refrigerator, the apparatus has applications not only in critical emergencies, but also for small-scale needs such as producing ‘orphan drugs.’
"The goal of this project was to build a small-scale, portable unit that was completely integrated, so you could imagine being able to ship it anywhere. And as long as you had the right chemicals, you could make pharmaceuticals," said Klavs Jensen, the Warren K. Lewis Professor of Chemical Engineering at MIT, and co-author of the study.
The concept of a mobile pharmacy was inspired by needs for life-saving drugs in times of emergency. "Think of this as the emergency backup for pharmaceutical manufacturing," says Allan Myerson, MIT professor in the Department of Chemical Engineering, and co-author of the study. "The purpose is not to replace traditional manufacturing; it's to provide an alternative for these special situations."
In the typical manufacturing of pharmaceuticals, medicines are produced via a “batch processing” system often involving multiple locations. This significantly lengthens the time it takes to go from raw active ingredients into medicines that can be administered to patients. Another limitation is that the system is quite rigid in its design, which means it can’t be easily modified to meet demand surges. Moreover, this inflexibility could be disastrous when any point of the processing is disrupted, either by power failure or natural catastrophes.
The mobile pharmacy operates on a different approach, using flow processing instead of batch processing. This means that all steps of drug manufacturing is done in one location, including synthesis, purification, and final formulation. To make it work, researchers replaced the huge vats that are typical of manufacturing plants with small tubes, which are easier to cool and control.
The specifications on this refrigerator-sized machine include temperatures up to 250 degrees Celsius, and pressures up to 17 atmospheres. It also has different modules where chemicals are synthesized, purified, and formulated as solutions or suspensions. The modules and its components allow reconfiguration of the chemicals in order to produce different drugs. "Within a few hours we could change from one compound to the other," said Jensen.
The machine, with funding by the Defense Advanced Research Projects Agency (DARPA), can produce four drugs: Benadryl, licodain, Valium, and Prozac. Each drug is ensured to be at the correct concentration via an ultrasound monitoring system inside the machine. Its estimated current pace of production is an impressive 1,000 doses of a given drug within 24 hours.
In the next phase of the design, the team will improve on this machine by making it even smaller while increasing its synthesis capacity. This will include drugs that are more complex and formulations in pill form.
But already, the machine has applications as part of a back-up pharmacy system, ready to be deployed to alleviate drug shortages. Importantly, it is also quite useful in small-scale drug production for clinical trials, or to treat rare diseases with orphan drugs. "Sometimes it's very difficult to get those drugs, because economically it makes no sense to have a huge production operation for those," said Jensen.
Additional source: MIT press release