Manufacturing drugs is a complexprocess, often involving multiple facilities and taking weeks ormonths to arrive at the finished article. The lack of flexibility inthe system led MIT researchers to develop a compact, all-in-onesolution to allow for streamlined, speedy drug production. It can beadjusted to produce different medications, and isn't designedto replace existing manufacturing plants, but rather to complementthem by providing, for example, an emergency backup solution should afacility have to be shut down.
While it's not quite as laborious asactually developing new medication, drug manufacturing is usually apretty complex process. Normal procedure makes use of a "batchprocessing" setup, wherein the ingredients of the drug aresynthesized at one location, before being shipped to a second plantto be turned into a consumer-ready product.
When everything is running smoothly,this multi-site approach works fine, but when disruptive events occur– such as significantly increased demand, or even a plant shut down – the setup can't cope, potentially even grinding to a completehalt.
That's where the new system steps in –allowing for fast, portable and generally much more versatileproduction of a selection of drugs. Funded by DARPA, the idea is fairly simple, scaling down every stage of production so thatbatches are much smaller, but everything is more manageable, allowingfor an all-in-one setup. It's not an entirely new idea – MITactually came out with a much larger version (24 x 8 x 8 ft, or7.3 x 2.4 x 2.4 m) around five years go – but the new setup is more developed,and at roughly the size of a household fridge, it's compact enough tobe practical.
The design is split into two modules,with the first being where the reactions that synthesize the drugtake place, at temperatures up to 250 °C (482 °F) and pressures of up to 17 atmospheres. In traditionalmanufacturing, this process takes place in large vats, which aredifficult to keep cool. The compact system gets around the issue byhousing the reactions within small tubes that can have theirtemperatures more easily manipulated.
Once the reactions have taken place,the solution is sent to a second module where it's purified bycrystallization, before being filtered and then dried. Finally, it'sdissolved or suspended in water at the required dose level. Thisprocess is monitored by an ultrasound system to confirm that theconcentrations are correct.
Aside from its compact, all-in-onenature, the other big benefit of the new machine is its speed.Whereas batch processing can take months to arrive at a finisheddrug, the new solution can produce consumer-ready medication in aslittle as 24 hours, allowing it to quickly respond to disruptivesituations.
It's able to produce four differentdrugs – Benadryl, lidocaine, Valium and Prozac – simply bychanging the setup of the first stage, an adjustment that takes justa few hours. In testing, around 1,000 doses of a given drug wereproduced in a period of 24 hours.
Not onlycould the system come in useful if normal manufacturing procedures were, forwhatever reason, disrupted, but it could also be used to producesmall batches of drugs that would otherwise be too expensive forpharmaceutical companies to manufacture. Such medication, known as "orphan drugs," could be helpful to patients, but don't benefitfrom high levels of demand.
While the new system is pretty compact,the team is still working to shrink things down, aiming to create anew version that's 40 percent smaller than the current hardware, making it more convenient. Theresearchers also hope to make the next machine more capable, with theability to produce more complex drugs. The possibility of producingtablets, rather than just liquid drugs, is also being investigated.
Full details of the work can be found in the journal Science.
Source: MIT