New, portable system can be configured to produce different drugs

MIT researchers have developed a compact, portable pharmaceutical manufacturing system that can be reconfigured to produce a variety of drugs on demand.

Just as an emergency generator supplies electricity to handle a power outage, this system could be rapidly deployed to produce drugs needed to handle an unexpected disease outbreak, or to prevent a drug shortage caused by a manufacturing plant shutdown, the researchers say.

In the new endeavor, funded by the Defense Advanced Research Projects Agency (DARPA), the MIT researchers built on what they learned from the Novartis-funded project to create a much smaller, transportable device. Their new system can produce four drugs formulated as solutions or suspensions — Benadryl, lidocaine, Valium, and Prozac. Using this apparatus, the researchers can manufacture about 1,000 doses of a given drug in 24 hours.

Key to the continuous system is the development of chemical reactions that can take place as the reactants flow through relatively small tubes as opposed to the huge vats in which most pharmaceutical reactions now take place. Traditional batch processing is limited by the difficulty of cooling these vats, but the flow system allows reactions that produce a great deal of heat to be run safely.

The chemical reactions required to synthesize each drug take place in the first of two modules. The reactions were designed so that they can take place at temperatures up to 250 degrees Celsius and pressures up to 17 atmospheres. By swapping in different module components, the researchers can easily reconfigure the system to produce different drugs.

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.

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 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.