Do needles make you wince? Boris Stoeber feels your pain. So he developed technology that will make getting flu and other kinds of shots a breeze.
Stoeber, PEng, a professor in UBC’s Departments of Mechanical Engineering and Electrical and Computer Engineering and the Canada Research Chair in Microfluidics and Sensing Technology, works on microneedles: thorn-like projections less than a millimetre long that may revolutionize the way drugs and vaccines are administered.
Today this revolution moved one step closer, with the announcement that Stoeber’s company, Microdermics, has signed a strategic cooperation agreement with Vetter Pharma, a global leader in clinical development and manufacturing. Microdermics closed a $1 million financing round in April.
The hypodermic needle and syringe, whose basic design and mechanics have remained essentially the same for over 160 years, cause pain and bleeding because they pierce tissue containing nerves and blood vessels.
Microneedles, on the other hand, puncture only the outermost layer of skin -- the stratum corneum -- which is nerve- and blood vessel-free. The drug or vaccine is then delivered directly into the skin or diffuses from the microneedle to the vessels underneath, making the whole process painless and clean.
In fact, many drugs and vaccines are more effective when delivered into the upper skin layers instead of blood, muscle or subcutaneous tissue. For instance, vaccines trigger stronger immune responses when administered into the skin, which is rich in immune cells. This means that by using microneedles, immunization campaigns can achieve the same results with less vaccine -- up to 80% less.
“Not only would the cost savings be significant, but it could also save lives when there’s a shortage of vaccine -- like right now, with the yellow fever vaccine,” says Stoeber. “We’d be able to treat five times as many yellow fever patients with microneedles, for example, than we can with conventional delivery technology.”
Injecting a vaccine into the skin also prevents it from going to places in the body it shouldn’t, and other therapeutic agents, such as insulin, are actually absorbed more efficiently through the skin.
Microneedles trump hypodermics in other respects, as well. They are easier to store, distribute and dispose of. They minimize the risks of needlestick injury and infection. And because they are so safe and simple to use, they may allow people to self-administer drugs and vaccines. The adoption of microneedles could also improve compliance in clinical trials, immunization programs and insulin regimens: injection-related pain and anxiety are reasons why many adults avoid getting important medical care for themselves or their children.
These advantages, which would be particularly beneficial in developing countries, will likely boost global vaccination coverage and help eliminate vaccine-preventable diseases such as measles.
Stoeber began researching microneedles in the late 1990s, as a PhD student at the University of California, Berkeley. Today he is co-founder and CTO of Microdermics, a Vancouver-based UBC spin-off that will commercialize a hollow metal microneedle delivery platform which is cheap, customizable and won’t break when inserted into the skin. Microdermics’ unique manufacturing process, which utilizes reusable molds and inexpensive equipment, is low-cost and scalable.
They do have competitors. Although no microneedle products are yet on the market for medical applications (they are available for cosmetic ones, mostly in Asia), a number of other research groups, including at industry giants like 3M and Fujifilm, are developing microneedle platforms of their own. But most of these are costlier to produce, cause pain due to their large size, are more prone to breakage or fail to target therapeutically ideal skin cells.
Getting regulatory approval may also be more onerous for them. Microneedles that dissolve into the skin upon injection, for example, encapsulate the drug in a biodegradable matrix -- a new formulation, according to regulatory agencies, which must undergo the grueling drug approval process before it can be made available. In contrast, Microdermics’ needles can simply be loaded with the desired dose of an existing drug or vaccine formulation and applied immediately, just like conventional needles.
More recently, Stoeber has explored how microneedles can improve therapeutic drug monitoring, a process that can require multiple blood collections, expensive medical tests and protracted hospitalizations as people wait for the test results to arrive.
Drawing on their expertise in microfluidics, optics and biotechnology, Stoeber and his colleagues created a microneedle system that can not only extract a miniscule amount of interstitial fluid from the skin, but also analyse that fluid to determine the concentration of antibiotic in the patient’s blood -- all at the patient’s bedside. This device has the potential to drastically reduce the distress, time and money involved in monitoring patient health.
Microdermics plans to conduct human clinical trials later this year. If all goes well, we can look forward to getting vaccinated with microneedles as early as 2020.