From the Lab to the Pharmacy: Commercializing Microarray Patch Products Will Unlock a New Era in Drug Delivery
The Microarray Patch or Microneedle Patch is poised to transform drug delivery. They’ve already changed the skincare market, and the medical market is following. Microarray patches (MAPs) can reliably release medicinal compounds across the skin barrier painlessly and more effectively than oral or topical applications. Commercializing MAPs will unlock a new era in drug delivery.
While Microarray Patches may seem new, transdermal drug delivery has existed since the late 1970s. From the first motion sickness and smoking cessation patches to the latest technology, they are safe, effective and easy to use.
But getting from the lab to the pharmacy takes time, technology and money. The latest advances in patch design and manufacturing methods confirm the significance of this ground-breaking healthcare technology. As researchers discover countless applications, the race to bring them to market is on.
How will MAPs impact you and me?
Vaccines, medicines, and other treatments delivered via a MAP mean:
o no more costly cold chain transportation and storage
o reduced visits to clinics for treatment and hypodermic needles
o painless drug delivery
o reduced use of pills and eliminating “first-pass” efficacy challenges
o increased patient compliance
o massive benefits to traditionally underserved populations
What is a Microarray Patch and How Does it Work?
A Microarray Patch looks like a small bandage—an array of microscopic needles project at specific lengths for each application on its surface. When you apply it to your skin, the tiny needles penetrate the outermost layer – the epidermis – and deliver the drug or vaccine to the top layers of the skin. Your body absorbs the medicine over time.
Unlike painful hypodermic needles that deliver drugs subcutaneously (under the skin), MAPs deliver into the skin.
And best of all, applying a MAP is painless.
PATH recently observed that drug delivery into the skin “might also create a stronger immune response with less vaccine. This could ultimately accelerate the uptake of vaccines since a limited amount of vaccine antigen could be used to vaccinate more people.”
MAPs are destined to replace traditional drug delivery mechanisms like the hypodermic needle. They are easy to use at home and don’t require special administration. They avoid the “first-pass” effect of tablets and liquids, where the liver and gut absorb a fraction of the drug before it reaches its target.
There are several knock-on advantages of MAPs, like equitable drug delivery, reduction of harm, and environmental benefits.
Different Types of Microarray Patches
Until recently, there were six main types, as seen below.
Source: Recent advances in porous microneedles: materials, fabrication, and transdermal applications
Each type offers advantages depending on the drug administered. However, some trade-offs can affect dosage consistency.
The good news is that the team at ArrayPatch has introduced a new type of MAP that delivers a consistent dosage.
Team lead Dr. Waleed Faisal says, "Microneedles are typically made of polymers so they could be strong and sharp and then loaded with medication. However, only a small percentage of the needle involves the actual drug.
What we have done with ArrayPatch, our wearable microneedle patch, is to build the needle out of pure medication. We make a powder of the drug, melt it and shape it into a microarray with about 100 tiny needles. It penetrates the skin on application and then dissolves to deliver a local effective dose of medication.”
ArrayPatch improves patient outcomes and reduces treatment times by providing effective treatment with lower doses delivered painlessly. The first commercial version of ArrayPatch targets fungal fingernail and toenail infections.
“We are now at the commercialization stage, working with our partners at Harro Höfliger to bring this novel technology and treatment to market,” says Dr. Faisal.
Getting From the Lab to the Pharmacy
New microarray patch solutions are being developed and validated faster than ever. But getting from the lab to the pharmacy is challenging. According to Dr. Faisal, part of the problem is that “researchers tend to focus on publication. But once you disclose your concept in that way, you can’t apply for a patent. We’ve protected our intellectual property and have applied for a patent.”
Like every new technology, early adoption is a double-edged sword. There are risks, but the potential rewards are great. And turning successful laboratory-based processes into commercial products requires deep pockets and a willingness to refine the process to manufacture at scale.
As Dr. Faisal notes, “the deliverables for commercialization funding are quite different.”
Industry leaders are reducing risks for partners looking to commercialize applications by investing heavily in manufacturing and production technology. They know how to manage production costs, demonstrate efficacy and navigate complex regulatory landscapes.
However, lab-based processes don’t always translate well to commercialized production. Companies like LTS Lohmann and Harro Höfliger are developing manufacturing techniques to speed the transition to volume-driven processes and establish MAPs as a market-viable technology. They aim to minimize the risk of potential delays and additional costs for companies and their investors.
Successfully commercializing MAP technology helps pharmaceutical clients reduce the time-to-market and cost of developing a drug product using this platform.
Dr. Faisal is optimistic about MAP technology. “Simplifying and improving treatment has massive benefits for patients everywhere. And the potential financial return for early adopters from this technology makes it an exciting opportunity for investors.”
6 Benefits of MAP Technology
Commercializing and scaling the manufacturing cycle can reduce a product's lifetime cost. However, investors and consumers often need guidance to understand their potential.
Here are 6 benefits of MAP technology:
MAPs are non-invasive.
They can be self-administered, reducing or eliminating travel to clinics and increasing patient compliance.
The first-pass effect does not impact dosing and can be fine-tuned.
There is no need for special storage temperatures.
Painless application is a winning formula.
Biohazardous waste and needlesticks injuries associated with hypodermic needles are eliminated.
These benefits make MAP technology a more competitive proposition than many may perceive. The platform typically targets vaccines, high-potency biologics, and mRNA lipid nanoparticles. These economics of commercialization open the door to compatible small-molecule active pharmaceutical ingredients and applications that address unmet medical needs or provide an appealing alternative to injection.
The market for MAPs is maturing fast, and costs are likely to recalibrate further as efficiencies are increased, pass-through times improve, and yields grow. Pharma partners are adjusting their stance on MAPs, reevaluating the cost of the opportunity in a competitive market.
Successfully commercializing a new MAP technology is an opportunity to gain market share and acquire valuable knowledge. It leads to stronger Intellectual Property and expertise that can be fed into future developments.
Microarray Patch technology is no longer a pipedream within universities and academia. It’s starting to emerge in pharma companies' development pipelines. Gaining the first-mover advantage in the race to commercialize a drug product is critical.
Companies like ArrayPatch are developing better drug delivery with microarray patch technology. They are well-positioned to solve medical issues, meet the demands of patients and lead the transition to a new era of safe, accessible, and painless solutions.
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