Leveraging Established mRNA Vaccine Quality Standards to Guide the Transition into Emerging mRNA Therapeutics

• Distinguishing drug-substance CQAs from drug-product CQAs to clarify where controls need to be applied
• Setting phase-appropriate specifications that evolve from Phase I through later-stage development
• Determining what level of heterogeneity is acceptable without compromising safety, potency or manufacturability

Speakers:

Ioannis Rabias

Head of QC

Hellenic Pasteur Institute