Adapting CMC & Quality by Design for Individualised mRNA-LNP Therapies

11:30 am - Friday 19th February 2027

  • Applying phase-appropriate CMC strategies to enable the efficient development and clinical translation of individualised mRNA-LNP therapies
  • Leveraging Quality by Design (QbD) principles to build product and process understanding while maintaining flexibility for patient-specific treatments
  • Addressing comparability, control strategy, and regulatory considerations in the evolving landscape of personalised medicines

Speakers:

Associate Director GMP/CMC Drug Product
BioNTech