The door is open for making drugs on-site in doctors' offices, or even in space.
Kitson et alImage:
The pharmaceutical industry is the very definition of a centralization. It is, after all, an industry predicated on carefully litigated intellectual property, intense de facto regulatory and legal scrutiny, and large-scale, capital-intensive chemical manufacturing infrastructure. As such, it's slow-moving. Drug distribution is thus anticipatory rather than responsive.
This tends to work out at large (epidemiological) scales. But drug needs are not always so macro. Outbreaks are often abrupt and confined; in poor, rural areas, this may mean limited or no access to drugs that may otherwise be facts of life in more developed areas closer and better synced to the pharmaceutical system.
Philip Kitson and colleagues at the University of Glasgow have developed a new framework for 3D printing drug manufacturing devices on-site on an as-needed basis. All it requires is a $2,000 3D printer and a drug specification (the manufacturing processes required to produce it). Given such a specification, software created by Kitson's group dictates to the printer exactly what sort of manufacturing hardware it needs to print that is then capable of producing a particular drug. So, it's machines (microreactors, actually) for making specific drugs that are printed, not the drugs themselves.
Kitson and co.'s new system is described in the current issue of Science.
"We propose a concept whereby the large-scale manufacturing process of complex fine chemicals, such as APIs [active pharmaceutical ingredients], is augmented by distributed, point-of-use manufacturing in self-contained cartridges, requiring limited user interaction to produce the desired products on demand," the current paper begins.
"In this way, we aim to move beyond the preserve of industrial manufacturing and prototyping applications, to revolutionize the relationship between the design, manufacture, and operation of functional devices and exploit the increasing use of 3D printing in the automation of the chemical sciences."
The heart of the new system is less the hardware than the generation of standardized recipes for manufacturing specific drugs. The drug synthesis processes usually implemented in large-scale manufacturing schemes are instead translated into simple step-by-step workflows that can be translated by software into small manufacturing devices that can be cheaply 3D printed. As proof-of-concept, Kitson's team produced baclofen, a muscle relaxant, from readily available chemical precursors (chemicals that change into other chemicals) using a three-step process.
It'd be hard to overstate the potential of this sort of drug (or chemical, generally) manufacturing.
"By demonstrating the multistep synthesis of baclofen in this integrated, benchtop device, the door has been opened to making complex molecules, such as APIs, on demand in nontraditional manufacturing environments such as hospitals or even doctors’ offices, bringing manufacturing closer to the point of use," writes Christian Hornung, an Australian chemical engineering researcher, in a separate Science commentary. These manufacturing scenarios might also include remote settings, synthesis of personalized medicines, small-scale production of abandoned pharmaceuticals, or even space missions."
Obviously, there are some issues to be worked out here when it comes to regulation, but it's hard to think of an industry more worthy of tech disruption than pharmaceuticals.