Head of Formulation and Analytical Vaxxas Pty Ltd HAMILTON, Queensland, Australia
Continued advances in microarray patch (MAP) technology are starting to make needle-free delivery of a broad range of vaccines an achievable goal. The drivers and potential benefits of a MAP platform for pandemic response and routine vaccination are clear and include dose-sparing, cold- chain elimination, increased safety, and potential self-administration. Formulation factors such as type of excipient, ratio, total solids loaded on the MAP can have significant impact on delivery of the payload (vaccine, drug) across the skin. Balance between these factors is crucial to develop a stable formulation and achieve the desired delivery efficiency at the site of action. Also it is critical to understand the impact of coating processes on critical quality attributes (CQAs) and equally important to develop discriminatory test methods to determine stability indicating quality attributes to enable formulation down-selection and develop a robust analytical control strategy.
Learning Objectives:
The audience will understand the HD-MAP technology for vaccine delivery and delivery mechanism.
Importance of formulation factors and impact of manufacturing processes.
Criticality and challenges while developing discriminatory test methods.