Project description and overview:

Vaxxas is a clinical-stage biotechnology company commercialising a novel needle-free vaccination platform, the High-Density Micro-projection Array Patch (HD-MAP), to improve the efficacy, reach, safety and economics of vaccination. The Vaxxas HD-MAP is expected to revolutionize the delivery of vaccines, making the 169-year-old needle and syringe technology obsolete for many applications.

The manufacturing process includes the production of sterile HD-MAP devices and the coating of those devices with a vaccine product in a clean-room manufacturing facility. The company has completed Phase I clinical trials for three different vaccine products on the device platform and is poised to begin Phase II trials for one of those. Vaxxas must manufacture sufficient volume of safe and efficacious vaccine product whilst ensuring compliance to regulations for the Phase II clinical studies. At the same time there is a requirement to integrate automation and in-process quality control steps (using process analytical technologies) into the fill and finish manufacturing process to start closing the gap between late-stage-clinical and commercial production.

This project targets a significant bottleneck in the final product manufacturing process where the vaccine is applied to the HD-MAP in a controlled cleanroom environment. Specifically, the manual In-Process Testing and high level of manual manipulation steps associated with the existing Phase I manufacturing process, exposes the system to various risks (e.g. contamination, process shutdown, product integrity, loss of finished product) and inefficiencies (immovable bottlenecks).

In this project Vaxxas, together with its collaborators, proposes to leverage machine learning and artificial intelligence technologies to automate In-process checks and integrity testing, ultimately enabling a scaled-up, reliable, high-throughput cleanroom manufacturing process. The project will enable maximal throughput and reduce time to market, providing valuable competitive advantages to Vaxxas at a critical development point.

The project will build valuable datasets and experience in the requirements for improved in-process controls, product handling and advanced automation, throughout the entire manufacturing process.