The surge in mail-order drug deliveries, amid rising temperatures and climate volatility, presents a growing challenge to the security of the pharmaceutical supply chain, according to the New Jersey Institute of Technology.
Every time a vaccine is subject to excessive heat or cold, its potency may be diminished, according to the Centers for Disease Control and Prevention. A single exposure to freezing temperatures can destroy a batch entirely. With these trends in mind, a pair of New Jersey inventors set their sights on the “cold chain” – the controlled transport environment of medications traveling from manufacturer to customer – with a device that will alert health care providers if a medication has reached a temperature that may have compromised it.
Called ThermaProx, the device includes a proxy sensor clipped to individual vials and syringes that mimics the temperature profile of the dose of vaccine or insulin on its final journey, rather than simply recording the ambient temperature in which it traveled. If the medication freezes, the proxy turns blue; if it overheats, it turns a deep red, according to NJIT.
The proxy has the same amount of liquid as the medication in a container that is the same size, while the solution has the physical and chemical properties of the product it monitors, as well as its thermal mass. It contains a solution of a reactive ingredient in water that changes color when another reactive ingredient, encased in wax micro-capsules that are suspended in the solution, is released as the wax melts with overheating or cracks upon freezing.
“For example, both the vaccine material and the indicator can be water solutions or dispersions and hence have similar heat capacities such that the vaccine and the indicator would behave similarly at the same temperature,” Robert Geissler, a co-founder of the company ThermaProx, which is named after the technology, and an NJIT alumnus with a degree in electrical engineering, said.
“Now that more and more temperature-sensitive medications are being sent to patients by mail or delivery services, the probability of temperature excursions becomes greater,” said Nathaniel Cooperman, who conceived of the device several years ago and sought Geissler’s help to build it.
Geissler, a serial entrepreneur with four decades of experience in engineering technology sectors, and Cooperman, the developer of diverse chemical processes for the efficient utilization of materials, met several years ago as virtual tenants of NJIT’s Enterprise Development Center, now known as VentureLink. They have since developed prototypes in the university’s Makerspace.
“The rapid, inexpensive production of our syringe rod and syringe clip in the Makerspace allowed us to show prototypes to potential buyers and investors without long waits and large expense,” said Cooperman.
To date, they have obtained a dozen U.S. and foreign patents, including a version of their invention that includes the sensor as a replacement for the syringe rod itself that can be included as part of the pre-filled syringe manufacturing process.