See that tiny, pen-looking piece of polymer Gijsbert van de Wijdeven is holding with tweezers in this image? That’s how Bioneedle Technologies Group is hoping to help public health take a giant step forward.
Actually, that’s just one piece of it. The Netherlands-based company has developed what it thinks is a way to make transporting and administering vaccines safer and easier, especially for large populations in remote areas of the world.
At the core of the system is the Bioneedle (pictured). It’s a tiny, biodegradable implant about 1.5 cm long that’s filled with a dose of a temperature-stable vaccine and loaded into an applicator. The applicator, powered by compressed air (think of it like a mini blow pipe), shoots the implant into a person’s arm without ever touching the skin. It happens so quickly that it’s painless, the company says. Within minutes of implantation, the Bioneedle dissolves, releasing the vaccine into the bloodstream.
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It sounds simple enough, but there are several innovative components that have taken the company nearly a decade to develop – a pharmaceutical grade biomaterial, the Bioneedles themselves, the thermo-stability technology for the vaccines, and the applicator.
Public health organizations say vaccines are one of the most cost-effective ways to prevent unnecessary deaths and disease outbreaks. But they’re expensive for the world’s poorest countries, which often need them most of all. And shortages in supply, trained workers and reliable transport systems are also challenges.
As part of the Global Vaccine Action Plan, nearly 200 countries are supporting a plan to expand access to vaccines and prevent millions of deaths by 2020.
A number of other companies and organizations are developing innovative vaccine delivery technology of their own, from microneedle patches to nasal sprays to pre-filled, all-in-one syringes.
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Co-founder and CSO van de Wijdeven said the idea for the Bioneedle approach came, literally, “from a pig sty.”
A veterinarian by training, van de Wijdeven and his wife for a time ran their own veterinary practice where he worked on farm animals. But he was bothered by the century-and-a-half old technique of using a syringe for vaccinations. It creates unnecessary waste, puts people at risk for needle sticks and infections, and requires refrigeration, which makes transporting vaccines to remote areas a challenge.
Drawing on his background in biopolymer and pharmaceutical research, he came up with the Bioneedle idea and has been working for about nine years to turn it into a working technology.
“In the meantime we’ve stayed quiet because we wanted to do all of (the preclinical) studies first,” he said. “We’re working with a large number of specialists, machine builders, life science laboratories and designers,” as well as the Netherlands Vaccine Institute.
Van de Wijdeven said the company has the machines needed to manufacture the Bioneedles and has already completed a phase 1 study demonstrating that empty Bioneedles are safe to use on humans. The next step is ensuring that the manufacture process is CGMP compliant and securing approval from the FDA to begin clinical trials with actual vaccines.
To do that, it will need both time and money. By Van de Wijdeven’s estimate, it could be a year and a half to two years before clinical trials would begin, and three years before a pivotal trial, even if it uses vaccines that are already on the market inside of the Bioneedles. At the earliest, Bioneedle could have a product on the market in four years, he said.
“Preclinically we have given all proof of concept,” he said. “Clinically we have given proof of principal. We hope it is enough to raise enough money to get us to clinical trials.”
Based on its preclinical studies, Bioneedle Technologies thinks its system could be used for all kinds of vaccines, from protein-based vaccines like tetanus to composite vaccines like tuberculosis and live viruses. “We could also do vaccines that are new types, like RNA-based vaccines,” he said.
He’s hoping the system’s versatility will help move along the commercialization process. “We would be glad to partner with vaccine manufacturers to further the Bioneedle vaccination technology together,” he said.
