Michael Unbehauen
CMC Lead, mRNA Almirall
Seminars
Thursday 21st May 2026
Roundtable Discussion: Translating LNP Drug Product CMC Learnings to Enable Novel Excipients in mRNA Formulations
9:30 am
- Identifying the key principles for advancing LNP drug products through clinical phases while maintaining flexibility for evolving modalities and indications
- Evaluating when and why to introduce novel excipients and ionisable lipids into LNP formulations to balance innovation with CMC and regulatory risk
- Managing drug product CMC across development stages to ensure manufacturability, comparability, and clinical progression of LNP-based mRNA therapies
- Aligning formulation strategy, excipient selection, and control approaches to support robust CMC packages without over-engineering early programs
