BiopharmaPublished: June 10, 2026
The Definitive IND Readiness Checklist for mRNA Teams
B
Beacon Compliance Team
Biopharma Intelligence Unit
Preparing for an IND is an exercise in evidence coordination. Use this checklist to ensure your CMC package is aligned with 2026 reviewer expectations.
Analytical Characterization
- Particle size distribution via DLS and orthogonal method (NTA/Cryo-TEM)
- Encapsulation efficiency validation with Ribogreen
- RNA integrity and purity profiling
- Lipid component identity and purity