The COVID-19 pandemic has changed every aspect of the way we live. It has also revealed challenges in healthcare that already existed, but which were not a concern for the general population before the global pandemic and its media coverage. In 2019, WHO listed vaccine hesitancy as one of the top 10 threats to global health. Along with COVID-19, this fear has actualised, as a significant part of the population is still unvaccinated worldwide, even though vaccines are readily available. Most vaccines are administered using conventional injection needles intramuscularly. While there are different reasons for people to avoid vaccination, needle phobia plays an important part up to 30% of the world’s population is afraid of injections with needles. An innovation that has real potential to change this is the use of a microneedle patch.
Unlike injection needles, microneedle patches deliver drugs painlessly through the skin to humans and animals. They can be applied by anyone without training and do not require a cold-chain infrastructure to transport and store them, which could make it easier to medicate people living in remote regions. In addition to injections, microneedle patches also have advantages over oral and transdermal formulations, as they allow the drug to pass through the metabolic system and skin without any loss of the administered dose. The application of a microneedle patch is extremely simple: press the patch against the skin and remove the back layer, ;which positions the needles inside the skin, where the needles dissolve to release the drug in a controlled manner. After that, the patch can be disposed of into a regular rubbish bin since the materials are biofriendly.
“After almost 20 years of lab experience with different biomaterials in the drug delivery field, our lab envisioned the application of polymeric-based microneedles as the perfect platform to deliver medicines across the skin. The uniqueness of our microneedles lies in their fabrication process and how the drug is contained inside them,” says the team leader, Professor Hélder A. Santos.
Currently, the team focuses on developing prototypes for the administration of two different drugs for veterinary markets. The advantage in the veterinary pharmaceutical markets is that they have substantially lower regulatory and clinical trial barriers compared to human pharmaceutical markets, while also having the same demand for improved patient compliancy and user experience. The preclinical experiments are ongoing with the aim of showing the safety of the microneedle patches and improved efficacy over conventional dosage forms. The initial strategy is to prove that the technology is groundbreaking in the pharmaceutical target markets.
A recent article published by Professor Santos’ Lab monitors the breakthrough progress in the development of microneedles for immunotherapy. “We discussed using microneedles for immunotherapy due to the high abundance of immune cells under the skin. This approach can be applied to vaccination or the treatment of different diseases, such as cancer and autoimmune disorders, with minimal invasiveness and side effects. However, the advantages of microneedles are not limited to vaccinations; they can improve the administration of, for example, hormones and drugs of high clinical potency,” says Professor Santos.
In addition,microneedle patches use biocompatible dissolving or swelling polymers, which allow the drug to be released in different physiological conditions.
The review article highlights that microneedles have many outstanding properties, such as the ability to directly deliver antibodies, allergens and therapeutic antigens into the skin and to bypass the first-pass metabolism, allowing the direct translocation of therapeutics into the systematic circulation. Other properties include minimal invasiveness, facile fabrication, excellent biocompatibility and convenient administration. Moreover, transdermal microneedles can improve the biological effect of drugs through adjustable drug release.
“Our strength is that we have a very multidisciplinary and skilful team with extensive expertise in the field, who are tackling all the requirements for moving this microneedle technology from the bench to the market,” says Assistant Professor Mohammad-Ali Shahbazi.
First, as a platform technology, the potential markets are enormous, with applicability in treating both human and animal patients. However, developing products for pharmaceutical markets also brings challenges, as the formulations need to surpass the high regulatory barriers set by the regional medicine agencies as well as demonstrate high efficiency in clinical trials. These challenges are slightly easier to overcome in the veterinary medicine markets, where the demand is also high. Successfully demonstrating that a microneedle patch can treat medical conditions in animals also signals to actors in the pharmaceutical field that this can work on humans too. Second, another objective is to find commercial partners in the pharmaceutical industry to co-develop different microneedle formulations, for both human and animal use.
“The COVID-19 pandemic will certainly increase the awareness and interest of pharmaceutical companies towards new innovations in drug delivery technologies. As such, we expect that in the future we will see opportunities to co-develop microneedle patches for various medical applications in the pharmaceutical industry,” says commercial lead Antti Rahikkala.
The team consists of scientific and commercial teams, with overall leadership being in the hands of Professor Hélder A. Santos, an outstanding scientist with over 400 publications and 13,500 citations as well as hands on start-up experience. The science team is led by Assistant Professor Mohammad-Ali Shahbazi, also an accomplished scientist in pharmacy and preclinical development with start-up experience. The technology experts working on the lab side are Dr Nesma Ibrahim, a specialist in microneedle fabrication, Dr Flavia Fontana, a specialist in materials and drug delivery technologies and pre-clinical experimentation, and doctoral candidates Carmine d'Amico, MSc, and Khalil Elbadry, MSc. The commercial team consists of the commercial lead Dr Antti Rahikkala, who has experience in materials science and drug delivery technologies and is a co-founder and former CEO of another start-up, Dr Kajsa Kajander, who has experience in industrial R&D in pharmaceutics and medical devices, and Dr Andrea Dichlberger, who is an IP specialist with science experience in biomedicine. We have an experienced and skilled steering board with members representing expertise in veterinary medicine, drug formulation and delivery, the veterinary healthcare business, and product management. At the spinout stage, the company will need to hire executives (a CEO and CTO), marketing professionals and possibly regulatory professionals.
Administering drugs via a normal injection needle is painful and undesirable to humans and animals. Furthermore, cold-chain supply management is often needed in the logistics of injectables, which limits their availability in rural areas. Additionally, it has been estimated that 30% of the world’s population is afraid of injection needles, which may result in lower ;vaccination rates.
Microneedle patches are the next generation of drug delivery technology that will revolutionise the way we administer drugs to human and animal patients. Unlike injection needles, microneedle patches deliver drugs painlessly through the skin. One patch consists of hundreds of tiny microneedles, which dissolve within the skin when applied. The drug release time can be controlled, meaning that extended release is also possible.
Contrary to conventional injections, the application of microneedles is painless and can be administered by untrained people or the patients themselves. The logistics of microneedles is not dependent on a complex and expensive cold-chain storage system. Further, the material is biofriendly and thus can be disposed of with general waste.