Microarray patches (MAPs) are seeing interest from NGOs and governments as having the potential to revolutionize vaccine delivery. Here, GEN talks to Scott Fry, PhD, COO at Vaxxas, about the challenges of scaling up MAP manufacture to commercial scale.
GEN: What are you doing at Vaxxas?
Fry: We’ve developed our technology and successfully completed three Phase I clinical studies. We’re planning a manufacturing roadmap as we’re now confident that, in the foreseeable future, we’ll have line-of-sight to commercialization. I’ve got experience in scaling-up diagnostic tests and that’s why I’ve now come on board as COO.
GEN: What are three main challenges to scale-up and commercial manufacturing?
Fry: The first challenge is cost. We’re competing head-to-head with syringe fill-and-finish, which is highly optimized because it’s been in existence for a hundred years. Our target is to get to under one Euro a unit, which means we’ve had to make significant capital investments in high-speed automation before our technology is proven in a clinical environment.
Our second challenge is how rapidly we can increase our output. We have partnerships with the Bill & Melinda Gates Foundation and big pharmaceutical companies. As our technology has enormous potential, if we can demonstrate performance, we could be looking at an immediate demand for large quantities of product—and we need to manage that scaleup.
Finally, there’s a regulatory challenge. Our high-density MAPs (HD-MAP) are a completely disruptive technology with no predicate. They’re also a combination of drug substance and medical device. We need to satisfy the regulators that we can manufacture our product reliably and safely, as well as navigate both the medical device and drug substance regulatory pathways.
GEN: How are you overcoming these challenges?
Fry: We’re having to innovate. As well as inventing the HD-MAP, we’ve invented a head to print the vaccine onto each micro-projection in a single pass. We’re also leveraging experts who know how to, for example, build machines for aseptic manufacturing. Our MAP device is made from aluminum and stainless steel, due to cost and ease of recycling, and we’ve gone to experts who understand how to rapidly press metal parts.
In addition, we’ve made a careful selection of partners, such as the Gates Foundation, and we’re receiving good support from the U.S. government and the Australian government locally. Where we can, we also outsource to licensed vendors and suppliers. We’ve outsourced the scaling up of our reformulation and filtration processes, for example.