When I started my first job in college, I worked in a vaccine manufacturing facility. I was thrilled that my job was to do research and development on children’s vaccines. I relished in learning all I could about the process, utilities, valves, reactors, piping, separations processes and philosophies involved, along with anything else they threw at me. I knew so little. I still marvel in wonder at the vast changes that occur in the industry on a daily basis.
A few years ago, I read an article about microneedles and started tracking the technology. Instead of using one long needle to penetrate the skin and deliver a dose into the muscular or subcutaneous tissue, microneedles inject medicine directly into the skin. The skin is the largest organ in the body and is key to transmitting much of the information from the world around us through the nervous system into the brain. Microneedle technology is growing in its application and will prove to be one of those disruptive technologies that we will tell our grandchildren about.
Microneedles are being researched by university groups and pharmaceutical companies alike for their applications in delivering vaccines and other medicines. Unlike other transdermal dosage forms, the use of microneedles is not restricted by the texture or the health of the skin. The data that is being reported with vaccine research associated with microneedles is amazing; much smaller doses of vaccines trigger the same immune response associated with current dosages.
Imagine doubling your current production capacity without building additional footprint onto your current bulk manufacturing facility. Simply changing the dosing mechanism and location of your dosage device allows very small doses of medicine to have profound effects on the body. This is beyond exciting!
Microneedles will dramatically affect the pricing of vaccines—making more vaccinations attainable worldwide. Another benefit: Vaccines may be able to be temperature stabilized so that the cold-chain storage and shipping costs are reduced by as much as 90 percent. According to current research, these factors account for over 80 percent of the costs associated with vaccines. If we can dramatically reduce these costs, manufacturing and deploying vaccines will become both more affordable for the patient population and more profitable for the companies that spend so much time and research perfecting them.
Initially, microneedles were studied primarily for delivery of vaccines, but very quickly the research has expanded to determine if they can be used for delivery of insulin and cancer fighting medicines. University of North Carolina and North Carolina State University have been researching a thin patch of microneedles that looks like a tiny bandage to provide glucose sensing and insulin dosing for patients with insulin-dependent diabetes. The biomedical engineering researchers at North Carolina State University have also expanded the usage of microneedles for delivery of cancer immunotherapies to targeted melanomas in animal studies. The immunotherapy work itself is very interesting, but using microneedles to change and enhance treatment to a localized and sustained dosage is likely to change the way we treat melanomas. The research group is also looking for partners to develop this research for basal cell carcinomas, another type of skin cancer.
At INTERPHEX this past year, my colleague and I discussed this and other dosage form changes that will radicalize our industry and our methods for administering many different kinds of medicines in the future. Do you have a fitness tracking device on your wrist? Imagine it being electronically connected to a medicine-dosing, wearable patch on your arm that automatically doses you with needed medicines as your body chemistry changes. Now imagine that same scenario for patients with Alzheimer’s or other diseases associated with old age who have trouble remembering to take their medicines.
The industry is on the brink of a cutting-edge breakthrough in dosing technology. Microneedles, through transdermal dosing, have the ability to reduce overall cost and increase effectiveness with an easy-to-use device. This truly is the trifecta of how the pharmaceutical industry improves the lives of its patients.
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