Panel Discussion: What Should Be Characterized at Drug Substance vs Drug Product Stage?

• Explore which attributes should be controlled before formulation versus reassessed in the final LNP product
• Debate how much characterization is enough at different stages of development without creating unnecessary analytical burden
• Benchmark industry approaches for defining CQAs, release strategies, and regulatory-ready analytical packages

Speakers:

Meredith Packer

Director, Analytical Development,

Nava Therapeutics

Marco Blanco

Principal Scientist,

Merck & Co