mRNA had its Cambrian explosion; 2025 is the speciation. At the mRNA‑Based Therapeutics Summit Europe in Frankfurt (Jan 28–30, Sheraton Frankfurt Airport), the industry is done debating whether mRNA works. Now it’s racing to make it reliable, affordable and indication‑specific.
What’s moving fast
Oncology steals the show: patient‑specific neoantigen vaccines collide with manufacturing TAT, while off‑the‑shelf shared‑antigen programs chase broader economics. Watch for trials pairing mRNA with checkpoint inhibitors and oncolytic viruses.
Delivery tech is the kingmaker. Lipid nanoparticles (LNPs) still dominate, but the edge goes to platforms proving extra‑hepatic delivery with tolerable reactogenicity. Keep an eye on adaptive ionizable lipids and charge‑shielding tricks.
Self‑amplifying RNA (saRNA) graduates from poster to plan, promising lower dose and longer expression windows—if innate immunity can be tamed.
Thermostability and cold‑chain relief are no longer nice‑to‑haves. The winning decks show weeks at 2–8°C or room‑temp stability using sugar glass or novel excipients without nuking potency.
Manufacturing reality: the cost curve decides the winners
Everyone loves a platform until they see the COGS line. If your release testing and plasmid prep aren’t automated, your margin disappears. Expect lively hallway talk on:
- Continuous in‑vitro transcription and next‑gen capping (co‑transcriptional vs enzymatic) trade‑offs.
- Template supply chains: synthetic DNA and cell‑free plasmid alternatives.
- In‑process analytics that predict potency early and cut failed batches.
Regulation, quality, trust
EMA/MHRA expectations are converging on lifecycle control, not just batch release. Sponsors need living control strategies, validated analytical methods and change‑managed process tweaks. Real‑world evidence from post‑authorization safety studies will tip payer decisions.
What to watch for in dealflow
- CDMOs with credible extra‑hepatic delivery data will be over‑subscribed.
- IP around LNP libraries remains a minefield—expect cross‑licensing and defensive M&A.
- Companion diagnostics for oncology vaccines become a serious line item.
Dates & venue: Jan 28–30, 2025, Sheraton Frankfurt Airport Hotel & Conference Center; the summit is positioned as Europe’s end‑to‑end mRNA forum with 200+ participants.
