Head of Formulation and Analytical Vaxxas Pty Ltd Brisbane, Queensland, Australia
Vaxxas is in the process of commercializing its novel needle-free vaccination platform, the high-density microarray patch (HD-MAP), which aims to improve the efficacy, reach, safety, and economics of vaccination. As a platform technology for vaccination aimed at control of endemic, epidemic, or pandemic diseases, MAPs are expected to transform vaccine delivery. They provide a valuable alternative for vaccines that are injected by needles and syringes (N&S), stored and transported in vials in the cold chain and delivered by highly trained healthcare workers. Vaxxas’ HD-MAP comprises an array of thousands of micro-projections, each coated with vaccine and contained within a single-use disposable applicator. The administration process for the HD-MAP is simple where the device is placed on skin and vaccine delivery is triggered by pressing down on the top of the device. This dynamic application results in localized cell death at the application site, generating ‘alarm signals’ (damage- associated molecular patterns) in combination with proximal delivery of antigen from the high-density array. For HD-MAPs, penetration of the high-density array of micro-projections through the stratum corneum of the skin is achieved via an integrated applicator. This has been designed to compete on cost and manufacturability with disposable prefilled syringes. The integrated applicator ensures a controlled, consistent skin penetration and delivery of the vaccine product with low reliance on technical expertise of the user. Enhanced thermo- stability of vaccine products, has been reported for seasonal influenza antigens, inactivated poliovirus vaccine (IPV) and measles rubella (MR) vaccine on the Vaxxas HD-MAP. Introduction of a new technology also requires a clear plan and data set to test usability/human factors in a real-world context. Manufacturing HD-MAP product for phase 1 clinical studies can be achieved relatively easily to the required compliance and quality standards. As an HD-MAP product moves into phase 2 and 3 trials, however, the regulatory compliance requirements increase substantially. The regulatory knowledge-base has been built around liquid vaccine filling for delivery by syringe. To qualify and manufacture a new technology, such as dry-coated MAPs, there are several aspects of manufacturing and quality standards that are likely to be unfamiliar to regulatory authorities and require new guidance. Several usability studies have been published indicating the general ease of use of Vaxxas MAP technology in both low/middle income and high-income countries, but both studies also highlighted the need for significant user education around technology introduction. The presentation will talk about the current status of MAPs (combination products), opportunities as well as challenges the MAP developers will face on the path of commercialization.
Learning Objectives:
Gain more knowledge of the MAP technology for vaccine delivery, the delivery mechanism as well as formulation and analytical methods to determine the dose loaded on MAPs.
Describe the manufacturing scale-up challenges and infrastructure requirements for MAP developers.
Describe potential regulatory challenges and requirements for vaccine MAPs.