Bassam Hallis
Head of Vaccine Development & Evaluation Centre UK Health Security Agency
Seminars
Wednesday 20th May 2026
De-Risking mRNA Vaccines Through GxP Evaluation: Converting Designed-In Quality into Licensable Evidence
10:00 am
- Translating quality decisions made at the starting material and purification stages into GxP-ready assay development, validation, and high-containment preclinical datasets that regulators can rely on from early development through licensure
- Ensuring modality and platform diversification (mRNA, saRNA, circRNA; LNP and emerging delivery systems) is reflected in fit-for-purpose quality evidence packages, rather than relying on legacy or “standard” approaches that fail to capture platformspecific risks
- Defining what “right-first-time” quality confirmation looks like for assay strategy, comparability, and effectiveness evaluation, and how misalignment between process design and evidence generation drives late-stage rework
