Researchers in the VCU School of Engineering’s Pharmacy on Demand initiative design drug manufacturing processes that shrink the environmental and industrial footprint as they expand global access to drugs. Thomas D. Roper, Ph.D., the school’s director of pharmaceutical engineering, is working on Pharmacy on Demand with colleagues from the Massachusetts Institute of Technology.
“The theme of my lab is miniaturization for the purpose of personalized medicine,” Roper said. “By taking processes from the macro scale to the micro scale, we are able to bring science and engineering closer to the patient.”
Pharmacy on Demand is an object lesson in these themes — in this case, the object is a pharmaceutical factory merely the size of a refrigerator. Pharmacy on Demand is creating small, configurable pharmaceutical manufacturing platforms that can ultimately be shipped to different locations to supply patients with locally produced, high-quality medicines.
In addition to providing pharmaceutical manufacturing where it has traditionally been absent, the units reduce environmental impact and make the manufacturing process safer. The units convert raw materials into active ingredients and formulated products in a continuous flow, avoiding the stops and starts of batch processing. This results in lower costs and less waste.
“In my opinion, the biggest advantage of these manufacturing facilities is footprint,” Roper said. “Take hydrogen, for example, which is highly flammable and explosive. If you have a big reactor with hydrogen under high pressure, imagine the safety parameters. In the case of Pharmacy on Demand, the much smaller manufacturing footprint is inherently safer because the chemical hazards are significantly reduced.”
Roper’s recruitment to VCU from GlaxoSmithKline was funded in large part by a substantial eminent scholar award from the Commonwealth Research Commercialization Fund (CRCF), the university’s first CRCF award in the eminent scholar category.
As he helps shape development of VCU’s pharmaceutical engineering initiative, Roper anticipates other projects in biological catalysis that will streamline the pharmaceutical manufacturing process further.
“Another way to manufacture things is biologically,” Roper said. “An area I am interested in is biological catalysis of reactions, so eventually you are creating medicines in an E. coli platform or even in human cells.”
In this paradigm, the medicine is not a tablet from an amber-colored bottle, but a chemical process that transfers the manufacturing to the patient’s body.
“In other words, if you string together chemical transformations that can be done by enzymes in a cell, you can effectively reduce the size of your manufacturing footprint,” Roper said.
He sees other trends away from the production of substances that patients take regularly and toward the creation of processes that play out in a patient’s body over time.
Roper also points to development of long-acting medicines that patients take only once every 60 to 90 days. When perfected, they would offer major advantages, including freedom from the stigma of disease and greater assurance that patients will actually take their medications.
“Compliance in pharmaceuticals is terrible. Even in cancer treatment, patients will not always take their medicine when they are supposed to,” Roper said.
He noted an additional advantage to many of the next-generation drugs — one harder to quantify.
“There is a general improvement in patient quality of life,” Roper said. “These treatments come closer to being cures, so people have to spend less time feeling like a patient.”