A joint manufacturing research project between the University of Sydney, Vaxxas and the Innovative Manufacturing Cooperative Research Centre is due to test end-user usability, manufacturability, patient acceptability and supply chain logistics of a new technology that aims to replace traditional needle and syringe for vaccinating people against diseases.
Vaxxas is an Australian based biotechnology company with the primary goal of commercialising an innovative, next generation vaccine delivery platform.
The company’s Micro-projection Array Patch (MAP) technology targets immunological cells below the surface of the skin.
The Vaxxas MAP is applied to the skin using a disposable applicator, containing and protecting the product and ensuring repeatable delivery into the skin.
This project focuses on the manufacture and testing of a prototype commercial applicator to de- risk the device design prior to the high capital investment of a pilot scale manufacturing equipment and Australian based pilot scale manufacturing facility.
University of Sydney researchers from the Faculty of Medicine and Health, Rachel Skinner, Cristyn Davies and Robert Booy, are working with Behnam Fahimnia from the Business School to undertake usability and acceptability studies including an in-clinic assessment and a logistic impact/disruption assessment.
Davies said the initial study provided valuable information and showed a lot of promise for the new vaccine delivery technology.
“With Vaxxas planning to develop and commercialise the device in Australia, the focus of our research will be how the applicator is perceived by patients and administrators here,” she said.
Skinner said Australia is a mature, developed vaccination market.
“What immunisation providers expect in using the device and its acceptance by immunisation providers and recipients alike may differ dramatically from those in developing countries,” said Skinner.
Vaxxas head of clinical operations Charles Ross said the company is at an important stage of the product development process.
“Before investing in manufacturing the applicator at pilot scale, we want to be confident that the device satisfies design, end-user and logistical requirements for its intended markets,” said Ross.
In 2015 Vaxxas conducted a WHO-funded study testing the usability and end-user acceptability of the Vaxxas applicator for polio vaccination in Benin, Nepal and Vietnam.
The application will be tested in several settings and across different age groups, in the workplace and at the local GP.
The findings will then be compared against the WHO usability study to ascertain different requirements from these different markets.
Vaxxas will begin a large Phase I clinical study in 2019. Alongside this, the University of Sydney’s Faculty of Medicine and Health will undertake an acceptability study for Vaxxas which will compare end-user and patient experience with the Vaxxas MAP technology compared to traditional needle and syringe vaccinations.
The logistics study will highlight how cost-effective and environmentally sustainable the new supply chain will be compared to the traditional decentralised cold chain.
There is also the opportunity to revolutionise the current vaccine supply chain through addressing the future trends of product serialisation and developing methods for analysing big digital data collected from various supply chain sources.