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By swapping in different module components, the researchers can easily reconfigure the system to produce different drugs. “Within a few hours we could change from one compound to the other,” Jensen says.
In the second module, the crude drug solution is purified by crystallization, filtered, and dried to remove solvent, then dissolved or suspended in water as the final dosage form. The researchers also incorporated an ultrasound monitoring system that ensures the formulated drug solution is at the correct concentration.
Small-scale manufacturing
John Lewin, the division director of critical care and surgery pharmacy at Johns Hopkins Hospital, says this type of manufacturing could bring down production costs and help patients get better access to the drugs they need.
“This sets the foundation for a new paradigm in terms of the way we manufacture pharmaceuticals and distribute them to patients,” says Lewin, who was not involved in the study. “Such a device could really meet a lot of the supply chain challenges here in the U.S. and around the world.”
One of the advantages of this small-scale system is that it could be used to make small amounts of drugs that would be prohibitively expensive to make in a large-scale plant. This would be useful for so-called “orphan drugs” — drugs needed by a small number of patients. “Sometimes it’s very difficult to get those drugs, because economically it makes no sense to have a huge production operation for those,” Jensen says.
It could also be useful in regions with few pharmaceutical storage facilities, because drugs can be produced on demand, eliminating the need for long-term storage.
“The idea here is you make what you need, and you make a simple dosage form, because they’re going to be taken on demand. The dosages don’t have to have long-term stability,” Myerson says. “People line up, you make it, and they take it.”
The researchers are now working on the second phase of the project, which includes making the system about 40 percent smaller and producing drugs whose chemical syntheses are more complex. They are also working on producing tablets, which are more complicated to manufacture than liquid drugs.
